Trial Outcomes & Findings for Dose Finding Study of HP802-247 in Venous Leg Ulcers (NCT NCT00852995)
NCT ID: NCT00852995
Last Updated: 2016-10-24
Results Overview
For each treatment group the area of each subject's target ulcer was measured on a weekly basis, for up to 12 weeks, or until wound closure, whichever occurred first, using a laser-based wound imaging system in conjunction with software to measure area. An average of the 12 measurements were assessed.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
228 participants
Primary outcome timeframe
Weekly, over the 12 week treatment period, or until wound closure, which ever occurred first
Results posted on
2016-10-24
Participant Flow
Subjects were screened at 34 sites in the US and one in Canada, between June 11, 2009 and May 5, 2011; sites included independent and hospital wound clinics and private practice sites.
Subjects entered a 2-week run-in; subjects whose wound radius decreased by \< 0.349 cm/2weeks and met all other inclusion/exclusion (I/E) criteria were eligible for randomization.
Participant milestones
| Measure |
B - Low Q14D
Low dose HP802-247 applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12
HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.
|
A - Low Q7D
Low dose HP802-247, applied at each visit
HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.
|
D - High Q14D
High dose HP802-247, applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12
HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.
|
C - High Q7D
High dose HP802-247, applied at each visit
HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.
|
E - HP802-247 Vehicle
Placebo (Vehicle), applied at each visit
Placebo (Vehicle): Placebo (Vehicle) consisting of:
Component 1 - acellular fibrinogen solution; Component 2 - acellular thrombin solution
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
46
|
43
|
44
|
45
|
50
|
|
Overall Study
COMPLETED
|
38
|
42
|
39
|
40
|
46
|
|
Overall Study
NOT COMPLETED
|
8
|
1
|
5
|
5
|
4
|
Reasons for withdrawal
| Measure |
B - Low Q14D
Low dose HP802-247 applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12
HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.
|
A - Low Q7D
Low dose HP802-247, applied at each visit
HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.
|
D - High Q14D
High dose HP802-247, applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12
HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.
|
C - High Q7D
High dose HP802-247, applied at each visit
HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.
|
E - HP802-247 Vehicle
Placebo (Vehicle), applied at each visit
Placebo (Vehicle): Placebo (Vehicle) consisting of:
Component 1 - acellular fibrinogen solution; Component 2 - acellular thrombin solution
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
4
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
4
|
0
|
0
|
1
|
2
|
|
Overall Study
Non-Compliance
|
0
|
0
|
0
|
2
|
0
|
|
Overall Study
Progressive Disease
|
1
|
0
|
0
|
2
|
1
|
|
Overall Study
Physician Decision
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Moved Out of Area
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Dose Finding Study of HP802-247 in Venous Leg Ulcers
Baseline characteristics by cohort
| Measure |
E - HP802-247 Vehicle
n=50 Participants
Placebo (Vehicle), applied at each visit
Placebo (Vehicle): Placebo (Vehicle) consisting of:
Component 1 - acellular fibrinogen solution; Component 2 - acellular thrombin solution
|
B - Low Q14D
n=46 Participants
Low dose HP802-247 applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12
HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.
|
A - Low Q7D
n=43 Participants
Low dose HP802-247, applied at each visit
HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.
|
D - High Q14D
n=44 Participants
High dose HP802-247, applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12
HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.
|
C - High Q7D
n=45 Participants
High dose HP802-247, applied at each visit
HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.
|
Total
n=228 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
62.1 years
STANDARD_DEVIATION 14.1 • n=93 Participants
|
61.7 years
STANDARD_DEVIATION 15.7 • n=4 Participants
|
62.6 years
STANDARD_DEVIATION 15.4 • n=27 Participants
|
59.8 years
STANDARD_DEVIATION 15.0 • n=483 Participants
|
61.8 years
STANDARD_DEVIATION 16.1 • n=36 Participants
|
61.6 years
STANDARD_DEVIATION 15.2 • n=10 Participants
|
|
Age, Customized
Female Age
|
69.1 years
n=93 Participants
|
61.8 years
n=4 Participants
|
67.7 years
n=27 Participants
|
65.1 years
n=483 Participants
|
69.7 years
n=36 Participants
|
66.5 years
n=10 Participants
|
|
Age, Customized
Male Age
|
58.4 years
n=93 Participants
|
61.6 years
n=4 Participants
|
60.1 years
n=27 Participants
|
56.0 years
n=483 Participants
|
58.2 years
n=36 Participants
|
59.0 years
n=10 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=93 Participants
|
20 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
22 Participants
n=483 Participants
|
20 Participants
n=36 Participants
|
93 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=93 Participants
|
26 Participants
n=4 Participants
|
29 Participants
n=27 Participants
|
22 Participants
n=483 Participants
|
25 Participants
n=36 Participants
|
135 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
13 Participants
n=36 Participants
|
55 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=93 Participants
|
32 Participants
n=4 Participants
|
33 Participants
n=27 Participants
|
37 Participants
n=483 Participants
|
32 Participants
n=36 Participants
|
173 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
12 Participants
n=483 Participants
|
8 Participants
n=36 Participants
|
48 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
37 Participants
n=93 Participants
|
34 Participants
n=4 Participants
|
30 Participants
n=27 Participants
|
30 Participants
n=483 Participants
|
33 Participants
n=36 Participants
|
164 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
14 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Weekly, over the 12 week treatment period, or until wound closure, which ever occurred firstPopulation: ITT population.: Subjects who received at least one dose of test article. The primary analysis was performed using a two-way ANCOVA model, which included treatment group (the effect of interest), site, and the baseline target wound area (the covariate), with significance being at P \< 0.05.
For each treatment group the area of each subject's target ulcer was measured on a weekly basis, for up to 12 weeks, or until wound closure, whichever occurred first, using a laser-based wound imaging system in conjunction with software to measure area. An average of the 12 measurements were assessed.
Outcome measures
| Measure |
B - Low Q14D
n=46 Participants
Low dose HP802-247 applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12
HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.
|
A - Low Q7D
n=43 Participants
Low dose HP802-247, applied at each visit
HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.
|
D - High Q14D
n=44 Participants
High dose HP802-247, applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12
HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.
|
C - High Q7D
n=45 Participants
High dose HP802-247, applied at each visit
HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.
|
E - HP802-247 Vehicle
n=50 Participants
Placebo (Vehicle), applied at each visit
Placebo (Vehicle): Placebo (Vehicle) consisting of:
Component 1 - acellular fibrinogen solution; Component 2 - acellular thrombin solution
|
|---|---|---|---|---|---|
|
The Average Percent (%) Change From Baseline in the Target Wound Area in Each Treatment Group Over the Twelve-week Double-blind Treatment Period.
|
-77.11 percent change
Standard Deviation 21.95
|
-70.15 percent change
Standard Deviation 21.66
|
-68.14 percent change
Standard Deviation 26.29
|
-72.89 percent change
Standard Deviation 27.27
|
-60.38 percent change
Standard Deviation 29.79
|
SECONDARY outcome
Timeframe: 14 weeks - the final visit for one subject was delayed by two weeksPopulation: ITT Populations: Subjects who received at least one dose of test article. Data were analyzed using the Kaplan-Meier survival procedure, with significance being at P \< 0.05.
This key secondary outcome was the days to wound closure based on a Kaplan-Meier survival analysis.
Outcome measures
| Measure |
B - Low Q14D
n=50 Participants
Low dose HP802-247 applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12
HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.
|
A - Low Q7D
n=46 Participants
Low dose HP802-247, applied at each visit
HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.
|
D - High Q14D
n=43 Participants
High dose HP802-247, applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12
HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.
|
C - High Q7D
n=44 Participants
High dose HP802-247, applied at each visit
HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.
|
E - HP802-247 Vehicle
n=45 Participants
Placebo (Vehicle), applied at each visit
Placebo (Vehicle): Placebo (Vehicle) consisting of:
Component 1 - acellular fibrinogen solution; Component 2 - acellular thrombin solution
|
|---|---|---|---|---|---|
|
Kaplan-Meier Probability of Non-Closure
01 week
|
1 Probability of Non-Closure
|
1 Probability of Non-Closure
|
0.977 Probability of Non-Closure
|
1 Probability of Non-Closure
|
1 Probability of Non-Closure
|
|
Kaplan-Meier Probability of Non-Closure
02 weeks
|
1 Probability of Non-Closure
|
0.978 Probability of Non-Closure
|
0.977 Probability of Non-Closure
|
1 Probability of Non-Closure
|
0.978 Probability of Non-Closure
|
|
Kaplan-Meier Probability of Non-Closure
03 weeks
|
0.98 Probability of Non-Closure
|
0.934 Probability of Non-Closure
|
0.977 Probability of Non-Closure
|
0.953 Probability of Non-Closure
|
0.889 Probability of Non-Closure
|
|
Kaplan-Meier Probability of Non-Closure
04 weeks
|
0.918 Probability of Non-Closure
|
0.934 Probability of Non-Closure
|
0.907 Probability of Non-Closure
|
0.907 Probability of Non-Closure
|
0.867 Probability of Non-Closure
|
|
Kaplan-Meier Probability of Non-Closure
05 weeks
|
0.898 Probability of Non-Closure
|
0.71 Probability of Non-Closure
|
0.814 Probability of Non-Closure
|
0.791 Probability of Non-Closure
|
0.707 Probability of Non-Closure
|
|
Kaplan-Meier Probability of Non-Closure
06 weeks
|
0.834 Probability of Non-Closure
|
0.596 Probability of Non-Closure
|
0.814 Probability of Non-Closure
|
0.791 Probability of Non-Closure
|
0.661 Probability of Non-Closure
|
|
Kaplan-Meier Probability of Non-Closure
07 weeks
|
0.706 Probability of Non-Closure
|
0.596 Probability of Non-Closure
|
0.628 Probability of Non-Closure
|
0.741 Probability of Non-Closure
|
0.591 Probability of Non-Closure
|
|
Kaplan-Meier Probability of Non-Closure
08 weeks
|
0.663 Probability of Non-Closure
|
0.431 Probability of Non-Closure
|
0.581 Probability of Non-Closure
|
0.537 Probability of Non-Closure
|
0.543 Probability of Non-Closure
|
|
Kaplan-Meier Probability of Non-Closure
09 weeks
|
0.534 Probability of Non-Closure
|
0.359 Probability of Non-Closure
|
0.558 Probability of Non-Closure
|
0.537 Probability of Non-Closure
|
0.445 Probability of Non-Closure
|
|
Kaplan-Meier Probability of Non-Closure
10 weeks
|
0.512 Probability of Non-Closure
|
0.332 Probability of Non-Closure
|
0.558 Probability of Non-Closure
|
0.537 Probability of Non-Closure
|
0.418 Probability of Non-Closure
|
|
Kaplan-Meier Probability of Non-Closure
11 weeks
|
0.512 Probability of Non-Closure
|
0.332 Probability of Non-Closure
|
0.393 Probability of Non-Closure
|
0.46 Probability of Non-Closure
|
0.418 Probability of Non-Closure
|
|
Kaplan-Meier Probability of Non-Closure
12 weeks
|
0.512 Probability of Non-Closure
|
0.276 Probability of Non-Closure
|
0.393 Probability of Non-Closure
|
0.379 Probability of Non-Closure
|
0.288 Probability of Non-Closure
|
|
Kaplan-Meier Probability of Non-Closure
13 weeks
|
0.42 Probability of Non-Closure
|
0.237 Probability of Non-Closure
|
0.393 Probability of Non-Closure
|
0.32 Probability of Non-Closure
|
0.288 Probability of Non-Closure
|
|
Kaplan-Meier Probability of Non-Closure
14 weeks
|
0.42 Probability of Non-Closure
|
0 Probability of Non-Closure
|
0.393 Probability of Non-Closure
|
0.32 Probability of Non-Closure
|
0.288 Probability of Non-Closure
|
SECONDARY outcome
Timeframe: Weekly, over the 12 week treatment period, or until wound closure, which ever occurred firstPopulation: ITT population. Subjects who received at least one dose of test article. The data at each week were analyzed using a two-way ANCOVA model, which included treatment group (the effect of interest), site, and the baseline target wound area (the covariate). Significance was attained at P \< 0.05.
For each treatment group the area of each subject's target ulcer was measured on a weekly basis, for up to 12 weeks, using a laser-based wound imaging system in conjunction with software to measure area.
Outcome measures
| Measure |
B - Low Q14D
n=50 Participants
Low dose HP802-247 applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12
HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.
|
A - Low Q7D
n=46 Participants
Low dose HP802-247, applied at each visit
HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.
|
D - High Q14D
n=43 Participants
High dose HP802-247, applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12
HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.
|
C - High Q7D
n=44 Participants
High dose HP802-247, applied at each visit
HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.
|
E - HP802-247 Vehicle
n=45 Participants
Placebo (Vehicle), applied at each visit
Placebo (Vehicle): Placebo (Vehicle) consisting of:
Component 1 - acellular fibrinogen solution; Component 2 - acellular thrombin solution
|
|---|---|---|---|---|---|
|
Percent of Change From Baseline in Target Wound Area at Each of the Twelve Double-blind Treatment Weeks.
Tx Week 1
|
-22.94 Percent change
Standard Error 3.97
|
-38.88 Percent change
Standard Error 4.14
|
-27.89 Percent change
Standard Error 4.27
|
-25.88 Percent change
Standard Error 4.26
|
-34.97 Percent change
Standard Error 4.17
|
|
Percent of Change From Baseline in Target Wound Area at Each of the Twelve Double-blind Treatment Weeks.
Tx Week 2
|
-39.94 Percent change
Standard Error 4.9
|
-58.95 Percent change
Standard Error 5.11
|
-46.06 Percent change
Standard Error 5.26
|
-43.69 Percent change
Standard Error 5.26
|
-49.89 Percent change
Standard Error 5.14
|
|
Percent of Change From Baseline in Target Wound Area at Each of the Twelve Double-blind Treatment Weeks.
Tx Week 3
|
-47.30 Percent change
Standard Error 5.0
|
-65.56 Percent change
Standard Error 5.22
|
-53.5 Percent change
Standard Error 5.37
|
-55.2 Percent change
Standard Error 5.37
|
-56.66 Percent change
Standard Error 5.25
|
|
Percent of Change From Baseline in Target Wound Area at Each of the Twelve Double-blind Treatment Weeks.
Tx Week 4
|
-59.55 Percent change
Standard Error 5.28
|
-73.46 Percent change
Standard Error 5.51
|
-62.14 Percent change
Standard Error 5.68
|
-60.68 Percent change
Standard Error 5.68
|
-63.92 Percent change
Standard Error 5.55
|
|
Percent of Change From Baseline in Target Wound Area at Each of the Twelve Double-blind Treatment Weeks.
Tx Week 5
|
-60.54 Percent change
Standard Error 5.29
|
-79.98 Percent change
Standard Error 5.52
|
-68.95 Percent change
Standard Error 5.68
|
-61.87 Percent change
Standard Error 5.68
|
-72.41 Percent change
Standard Error 5.55
|
|
Percent of Change From Baseline in Target Wound Area at Each of the Twelve Double-blind Treatment Weeks.
Tx Week 6
|
-63.93 Percent change
Standard Error 4.63
|
-81.05 Percent change
Standard Error 4.83
|
-76.01 Percent change
Standard Error 4.98
|
-74.7 Percent change
Standard Error 4.97
|
-81.06 Percent change
Standard Error 4.86
|
|
Percent of Change From Baseline in Target Wound Area at Each of the Twelve Double-blind Treatment Weeks.
Tx Week 7
|
-65.38 Percent change
Standard Error 4.64
|
-87.22 Percent change
Standard Error 4.84
|
-79.84 Percent change
Standard Error 4.99
|
-77.63 Percent change
Standard Error 4.98
|
-79.81 Percent change
Standard Error 4.87
|
|
Percent of Change From Baseline in Target Wound Area at Each of the Twelve Double-blind Treatment Weeks.
Tx Week 8
|
-66.62 Percent change
Standard Error 5.04
|
-83.00 Percent change
Standard Error 5.26
|
-80.6 Percent change
Standard Error 5.42
|
-81.58 Percent change
Standard Error 5.42
|
-81.98 Percent change
Standard Error 5.3
|
|
Percent of Change From Baseline in Target Wound Area at Each of the Twelve Double-blind Treatment Weeks.
Tx Week 9
|
-69.03 Percent change
Standard Error 4.78
|
-83.28 Percent change
Standard Error 4.99
|
-83.96 Percent change
Standard Error 5.14
|
-84.28 Percent change
Standard Error 5.14
|
-86.17 Percent change
Standard Error 5.02
|
|
Percent of Change From Baseline in Target Wound Area at Each of the Twelve Double-blind Treatment Weeks.
Tx Week 10
|
-76.19 Percent change
Standard Error 3.39
|
-89.65 Percent change
Standard Error 3.54
|
-85.79 Percent change
Standard Error 3.65
|
-86.98 Percent change
Standard Error 3.65
|
-87.74 Percent change
Standard Error 3.56
|
|
Percent of Change From Baseline in Target Wound Area at Each of the Twelve Double-blind Treatment Weeks.
Tx Week 11
|
-77.05 Percent change
Standard Error 3.57
|
-89.26 Percent change
Standard Error 3.72
|
-87.49 Percent change
Standard Error 3.84
|
-83.37 Percent change
Standard Error 3.83
|
-87.54 Percent change
Standard Error 3.75
|
|
Percent of Change From Baseline in Target Wound Area at Each of the Twelve Double-blind Treatment Weeks.
Tx Week 12
|
-80.69 Percent change
Standard Error 3.54
|
-90.67 Percent change
Standard Error 3.69
|
-86.87 Percent change
Standard Error 3.8
|
-84.52 Percent change
Standard Error 3.8
|
-86.93 Percent change
Standard Error 3.72
|
SECONDARY outcome
Timeframe: Over the 12 week treatment period or until the wound closed, which ever occurred first.Population: The non-parametric Cochrane Mantel Haenszel test with adjustment for pooled site was used to examine treatment effects at each time point on the proportion of responders who have an average of ≥50% reduction from baseline in wound area over the treatment period. The test was performed separately for each pair of an active treatment vs. placebo.
The area of each subject's target wound was measured at each visit and the proportion of subjects with a decrease in area from baseline ≥ 50% was calculated for each treatment group.
Outcome measures
| Measure |
B - Low Q14D
n=50 Participants
Low dose HP802-247 applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12
HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.
|
A - Low Q7D
n=46 Participants
Low dose HP802-247, applied at each visit
HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.
|
D - High Q14D
n=43 Participants
High dose HP802-247, applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12
HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.
|
C - High Q7D
n=44 Participants
High dose HP802-247, applied at each visit
HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.
|
E - HP802-247 Vehicle
n=45 Participants
Placebo (Vehicle), applied at each visit
Placebo (Vehicle): Placebo (Vehicle) consisting of:
Component 1 - acellular fibrinogen solution; Component 2 - acellular thrombin solution
|
|---|---|---|---|---|---|
|
Proportion of Subjects Achieving ≥ 50% Decrease in Target Wound Area From Baseline Through Week 13
Visit 2
|
8 Responders
|
17 Responders
|
5 Responders
|
6 Responders
|
13 Responders
|
|
Proportion of Subjects Achieving ≥ 50% Decrease in Target Wound Area From Baseline Through Week 13
Visit 3
|
22 Responders
|
29 Responders
|
20 Responders
|
20 Responders
|
21 Responders
|
|
Proportion of Subjects Achieving ≥ 50% Decrease in Target Wound Area From Baseline Through Week 13
Visit 4
|
28 Responders
|
34 Responders
|
23 Responders
|
24 Responders
|
31 Responders
|
|
Proportion of Subjects Achieving ≥ 50% Decrease in Target Wound Area From Baseline Through Week 13
Visit 5
|
32 Responders
|
38 Responders
|
28 Responders
|
27 Responders
|
34 Responders
|
|
Proportion of Subjects Achieving ≥ 50% Decrease in Target Wound Area From Baseline Through Week 13
Visit 6
|
36 Responders
|
40 Responders
|
32 Responders
|
31 Responders
|
36 Responders
|
|
Proportion of Subjects Achieving ≥ 50% Decrease in Target Wound Area From Baseline Through Week 13
Visit 7
|
36 Responders
|
39 Responders
|
33 Responders
|
34 Responders
|
42 Responders
|
|
Proportion of Subjects Achieving ≥ 50% Decrease in Target Wound Area From Baseline Through Week 13
Visit 8
|
36 Responders
|
43 Responders
|
38 Responders
|
35 Responders
|
41 Responders
|
|
Proportion of Subjects Achieving ≥ 50% Decrease in Target Wound Area From Baseline Through Week 13
Visit 9
|
36 Responders
|
43 Responders
|
36 Responders
|
37 Responders
|
41 Responders
|
|
Proportion of Subjects Achieving ≥ 50% Decrease in Target Wound Area From Baseline Through Week 13
Visit 10
|
41 Responders
|
40 Responders
|
38 Responders
|
37 Responders
|
40 Responders
|
|
Proportion of Subjects Achieving ≥ 50% Decrease in Target Wound Area From Baseline Through Week 13
Visit 11
|
42 Responders
|
44 Responders
|
39 Responders
|
39 Responders
|
43 Responders
|
|
Proportion of Subjects Achieving ≥ 50% Decrease in Target Wound Area From Baseline Through Week 13
Visit 12
|
40 Responders
|
42 Responders
|
42 Responders
|
37 Responders
|
41 Responders
|
|
Proportion of Subjects Achieving ≥ 50% Decrease in Target Wound Area From Baseline Through Week 13
Visit 13
|
45 Responders
|
45 Responders
|
40 Responders
|
38 Responders
|
40 Responders
|
SECONDARY outcome
Timeframe: Weekly, over the 12 week treatment periodPopulation: ITT Populations: Subjects who received at least one dose of test article. Analysis was by the Cochrane Mantel Haenszel (CMH) test
Treatment groups were compared for the proportion of wounds closed at each weekly visit. For subjects who dropped from the study, their remaining visit values were imputed using LOCF.
Outcome measures
| Measure |
B - Low Q14D
n=50 Participants
Low dose HP802-247 applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12
HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.
|
A - Low Q7D
n=46 Participants
Low dose HP802-247, applied at each visit
HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.
|
D - High Q14D
n=43 Participants
High dose HP802-247, applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12
HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.
|
C - High Q7D
n=44 Participants
High dose HP802-247, applied at each visit
HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.
|
E - HP802-247 Vehicle
n=45 Participants
Placebo (Vehicle), applied at each visit
Placebo (Vehicle): Placebo (Vehicle) consisting of:
Component 1 - acellular fibrinogen solution; Component 2 - acellular thrombin solution
|
|---|---|---|---|---|---|
|
Percentage of Participants With Complete Wound Closure at Each Visit
Week 12
|
46.0 percentage of participants
|
69.6 percentage of participants
|
58.1 percentage of participants
|
65.1 percentage of participants
|
64.4 percentage of participants
|
|
Percentage of Participants With Complete Wound Closure at Each Visit
Week 01
|
0 percentage of participants
|
4.3 percentage of participants
|
2.3 percentage of participants
|
0 percentage of participants
|
2.2 percentage of participants
|
|
Percentage of Participants With Complete Wound Closure at Each Visit
Week 02
|
2.0 percentage of participants
|
8.7 percentage of participants
|
2.3 percentage of participants
|
7.0 percentage of participants
|
11.1 percentage of participants
|
|
Percentage of Participants With Complete Wound Closure at Each Visit
Week 03
|
8.0 percentage of participants
|
23.9 percentage of participants
|
9.3 percentage of participants
|
14.0 percentage of participants
|
20.0 percentage of participants
|
|
Percentage of Participants With Complete Wound Closure at Each Visit
Week 04
|
10.0 percentage of participants
|
30.4 percentage of participants
|
18.6 percentage of participants
|
20.9 percentage of participants
|
28.9 percentage of participants
|
|
Percentage of Participants With Complete Wound Closure at Each Visit
Week 05
|
16.0 percentage of participants
|
37.0 percentage of participants
|
25.6 percentage of participants
|
23.3 percentage of participants
|
33.3 percentage of participants
|
|
Percentage of Participants With Complete Wound Closure at Each Visit
Week 06
|
24.0 percentage of participants
|
47.8 percentage of participants
|
39.5 percentage of participants
|
27.9 percentage of participants
|
40.0 percentage of participants
|
|
Percentage of Participants With Complete Wound Closure at Each Visit
Week 07
|
28.0 percentage of participants
|
52.2 percentage of participants
|
41.9 percentage of participants
|
39.5 percentage of participants
|
44.4 percentage of participants
|
|
Percentage of Participants With Complete Wound Closure at Each Visit
Week 08
|
36.0 percentage of participants
|
58.7 percentage of participants
|
41.9 percentage of participants
|
48.8 percentage of participants
|
51.1 percentage of participants
|
|
Percentage of Participants With Complete Wound Closure at Each Visit
Week 09
|
36.0 percentage of participants
|
60.9 percentage of participants
|
55.8 percentage of participants
|
48.8 percentage of participants
|
55.6 percentage of participants
|
|
Percentage of Participants With Complete Wound Closure at Each Visit
Week 10
|
40.0 percentage of participants
|
60.9 percentage of participants
|
60.5 percentage of participants
|
53.5 percentage of participants
|
62.2 percentage of participants
|
|
Percentage of Participants With Complete Wound Closure at Each Visit
Week 11
|
40.0 percentage of participants
|
65.2 percentage of participants
|
58.1 percentage of participants
|
60.5 percentage of participants
|
64.4 percentage of participants
|
SECONDARY outcome
Timeframe: Weekly, over the 12 week treatment periodPopulation: ITT Populations: Subjects who received at least one dose of test article. Data were analyzed by an ANCOVA, adjusted for site and baseline score.
Target ulcer pain was measured using a Visual Analog Scale \[Range: 0mm - 100mm\]. Subjects marked their pain level on a 100 mm horizontal line, with a short vertical line across the scale, 0 denoting no pain and 100mm the maximum pain. Each weekly measurement is reported as the average of all subjects scores at each week per treatment group.
Outcome measures
| Measure |
B - Low Q14D
n=50 Participants
Low dose HP802-247 applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12
HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.
|
A - Low Q7D
n=46 Participants
Low dose HP802-247, applied at each visit
HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.
|
D - High Q14D
n=43 Participants
High dose HP802-247, applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12
HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.
|
C - High Q7D
n=44 Participants
High dose HP802-247, applied at each visit
HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.
|
E - HP802-247 Vehicle
n=45 Participants
Placebo (Vehicle), applied at each visit
Placebo (Vehicle): Placebo (Vehicle) consisting of:
Component 1 - acellular fibrinogen solution; Component 2 - acellular thrombin solution
|
|---|---|---|---|---|---|
|
Target Ulcer Pain Was Measured Using a Visual Analog Scale [Range: 0mm - 100mm]. Subjects Marked Their Pain Level on a 100 mm Horizontal Line, With a Short Vertical Line Across the Scale, 0 Denoting no Pain and 100mm the Maximum Pain.
Baseline
|
30.82 units on a scale
Standard Deviation 31.22
|
21.11 units on a scale
Standard Deviation 25.23
|
28.6 units on a scale
Standard Deviation 21.77
|
29.84 units on a scale
Standard Deviation 26.36
|
25.47 units on a scale
Standard Deviation 27.7
|
|
Target Ulcer Pain Was Measured Using a Visual Analog Scale [Range: 0mm - 100mm]. Subjects Marked Their Pain Level on a 100 mm Horizontal Line, With a Short Vertical Line Across the Scale, 0 Denoting no Pain and 100mm the Maximum Pain.
Week 03
|
21.68 units on a scale
Standard Deviation 25.01
|
13.37 units on a scale
Standard Deviation 18.61
|
16.87 units on a scale
Standard Deviation 19.22
|
18.81 units on a scale
Standard Deviation 22.15
|
14.42 units on a scale
Standard Deviation 18.17
|
|
Target Ulcer Pain Was Measured Using a Visual Analog Scale [Range: 0mm - 100mm]. Subjects Marked Their Pain Level on a 100 mm Horizontal Line, With a Short Vertical Line Across the Scale, 0 Denoting no Pain and 100mm the Maximum Pain.
Week 06
|
10.72 units on a scale
Standard Deviation 18.22
|
10.35 units on a scale
Standard Deviation 20.43
|
7.35 units on a scale
Standard Deviation 13.36
|
12.25 units on a scale
Standard Deviation 17.96
|
11.61 units on a scale
Standard Deviation 19.03
|
|
Target Ulcer Pain Was Measured Using a Visual Analog Scale [Range: 0mm - 100mm]. Subjects Marked Their Pain Level on a 100 mm Horizontal Line, With a Short Vertical Line Across the Scale, 0 Denoting no Pain and 100mm the Maximum Pain.
Week 09
|
9.3 units on a scale
Standard Deviation 14.96
|
8.85 units on a scale
Standard Deviation 18.53
|
4.53 units on a scale
Standard Deviation 9.54
|
11.51 units on a scale
Standard Deviation 18.29
|
7.01 units on a scale
Standard Deviation 13.63
|
|
Target Ulcer Pain Was Measured Using a Visual Analog Scale [Range: 0mm - 100mm]. Subjects Marked Their Pain Level on a 100 mm Horizontal Line, With a Short Vertical Line Across the Scale, 0 Denoting no Pain and 100mm the Maximum Pain.
Week 12
|
7.95 units on a scale
Standard Deviation 13.34
|
6.83 units on a scale
Standard Deviation 11.72
|
3.28 units on a scale
Standard Deviation 6.83
|
13.22 units on a scale
Standard Deviation 20.71
|
6.61 units on a scale
Standard Deviation 13.43
|
SECONDARY outcome
Timeframe: 14 weeks - the final visit for one subject was delayed by two weeksPopulation: ITT Populations: Subjects who received at least one dose of test article. Data were analyzed using the Kaplan-Meier survival procedure, with significance being at P \< 0.05.
This key secondary outcome was the days to wound closure based on a Kaplan-Meier survival analysis.
Outcome measures
| Measure |
B - Low Q14D
n=50 Participants
Low dose HP802-247 applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12
HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.
|
A - Low Q7D
n=46 Participants
Low dose HP802-247, applied at each visit
HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.
|
D - High Q14D
n=43 Participants
High dose HP802-247, applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12
HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.
|
C - High Q7D
n=44 Participants
High dose HP802-247, applied at each visit
HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.
|
E - HP802-247 Vehicle
n=45 Participants
Placebo (Vehicle), applied at each visit
Placebo (Vehicle): Placebo (Vehicle) consisting of:
Component 1 - acellular fibrinogen solution; Component 2 - acellular thrombin solution
|
|---|---|---|---|---|---|
|
Median Time to Achieve Complete Wound Closure, Based on Based on a Kaplan-Meier Survival Analysis, Over the 12-Week Treatment Period From Baseline.
|
71 Days to Closure
Interval 57.0 to
Unable to assess upper limit. The placebo did not reach 50% closure.
|
50 Days to Closure
Interval 37.0 to 66.0
|
64 Days to Closure
Interval 43.0 to
Unable to assess upper limit. The placebo did not reach 50% closure.
|
57 Days to Closure
Interval 50.0 to 85.0
|
57 Days to Closure
Interval 43.0 to 71.0
|
Adverse Events
E - HP802-247 Vehicle
Serious events: 4 serious events
Other events: 26 other events
Deaths: 0 deaths
B - Low Q14D
Serious events: 4 serious events
Other events: 15 other events
Deaths: 0 deaths
A - Low Q7D
Serious events: 3 serious events
Other events: 19 other events
Deaths: 0 deaths
D - High Q14D
Serious events: 3 serious events
Other events: 16 other events
Deaths: 0 deaths
C - High Q7D
Serious events: 2 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
E - HP802-247 Vehicle
n=50 participants at risk
Placebo (Vehicle), applied at each visit
Placebo (Vehicle): Placebo (Vehicle) consisting of:
Component 1 - acellular fibrinogen solution; Component 2 - acellular thrombin solution
|
B - Low Q14D
n=46 participants at risk
Low dose HP802-247 applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12
HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.
|
A - Low Q7D
n=43 participants at risk
Low dose HP802-247, applied at each visit
HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.
|
D - High Q14D
n=44 participants at risk；n=43 participants at risk
High dose HP802-247, applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12
HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.
|
C - High Q7D
n=45 participants at risk
High dose HP802-247, applied at each visit
HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Splenic infarction
|
2.0%
1/50 • Number of events 1 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/46 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/43 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/43 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/45 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/50 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/46 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/43 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/43 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
2.2%
1/45 • Number of events 1 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
|
Cardiac disorders
Cardiac failure congestive
|
2.0%
1/50 • Number of events 1 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/46 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/43 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/43 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
2.2%
1/45 • Number of events 1 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/50 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
2.2%
1/46 • Number of events 1 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/43 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/43 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/45 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/50 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
2.2%
1/46 • Number of events 1 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/43 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/43 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/45 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
|
General disorders
Chest pain
|
0.00%
0/50 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
2.2%
1/46 • Number of events 1 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/43 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/43 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/45 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
|
Infections and infestations
Localised infection
|
0.00%
0/50 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/46 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/43 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/43 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
2.2%
1/45 • Number of events 1 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.00%
0/50 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/46 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
2.3%
1/43 • Number of events 1 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/43 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/45 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
2.0%
1/50 • Number of events 1 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/46 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/43 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/43 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/45 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.00%
0/50 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/46 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/43 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
2.3%
1/43 • Number of events 1 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/45 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.00%
0/50 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/46 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
2.3%
1/43 • Number of events 1 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/43 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/45 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/50 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/46 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/43 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
2.3%
1/43 • Number of events 1 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/45 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/50 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
2.2%
1/46 • Number of events 1 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/43 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/43 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/45 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
|
Skin and subcutaneous tissue disorders
Excessive granulation tissue
|
2.0%
1/50 • Number of events 1 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/46 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/43 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/43 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/45 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/50 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
2.2%
1/46 • Number of events 1 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/43 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/43 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/45 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.00%
0/50 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/46 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
2.3%
1/43 • Number of events 1 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
2.3%
1/43 • Number of events 1 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/45 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
Other adverse events
| Measure |
E - HP802-247 Vehicle
n=50 participants at risk
Placebo (Vehicle), applied at each visit
Placebo (Vehicle): Placebo (Vehicle) consisting of:
Component 1 - acellular fibrinogen solution; Component 2 - acellular thrombin solution
|
B - Low Q14D
n=46 participants at risk
Low dose HP802-247 applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12
HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.
|
A - Low Q7D
n=43 participants at risk
Low dose HP802-247, applied at each visit
HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.
|
D - High Q14D
n=44 participants at risk；n=43 participants at risk
High dose HP802-247, applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12
HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.
|
C - High Q7D
n=45 participants at risk
High dose HP802-247, applied at each visit
HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Cardiac Disorders
|
0.00%
0/50 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/46 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/43 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/44 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
4.4%
2/45 • Number of events 2 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
0.00%
0/50 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
2.2%
1/46 • Number of events 1 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/43 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
2.3%
1/44 • Number of events 1 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
4.4%
2/45 • Number of events 3 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/50 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/46 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/43 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/44 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
4.4%
2/45 • Number of events 2 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
|
General disorders
General disorders and administration site conditions
|
6.0%
3/50 • Number of events 4 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
4.3%
2/46 • Number of events 2 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/43 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
4.5%
2/44 • Number of events 2 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/45 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
|
Infections and infestations
Infections and infestations
|
18.0%
9/50 • Number of events 11 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
8.7%
4/46 • Number of events 4 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
18.6%
8/43 • Number of events 9 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
9.1%
4/44 • Number of events 5 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
17.8%
8/45 • Number of events 9 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
|
Infections and infestations
Cellulitis
|
6.0%
3/50 • Number of events 3 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
2.2%
1/46 • Number of events 1 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
4.7%
2/43 • Number of events 2 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/44 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/45 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
|
Infections and infestations
Infected skin ulcer
|
4.0%
2/50 • Number of events 2 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/46 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
2.3%
1/43 • Number of events 1 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
2.3%
1/44 • Number of events 1 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
4.4%
2/45 • Number of events 3 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
|
Infections and infestations
Wound infection
|
0.00%
0/50 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/46 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/43 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
2.3%
1/44 • Number of events 1 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
4.4%
2/45 • Number of events 2 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications
|
8.0%
4/50 • Number of events 4 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
4.3%
2/46 • Number of events 2 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
9.3%
4/43 • Number of events 5 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
9.1%
4/44 • Number of events 4 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
2.2%
1/45 • Number of events 1 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
|
Injury, poisoning and procedural complications
Excoriation
|
4.0%
2/50 • Number of events 2 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/46 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
4.7%
2/43 • Number of events 2 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/44 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/45 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders
|
0.00%
0/50 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
6.5%
3/46 • Number of events 3 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
2.3%
1/43 • Number of events 1 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
2.3%
1/44 • Number of events 1 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
6.7%
3/45 • Number of events 3 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/50 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
4.3%
2/46 • Number of events 2 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
2.3%
1/43 • Number of events 1 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
2.3%
1/44 • Number of events 1 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/45 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
|
Nervous system disorders
Nervous system disorders
|
4.0%
2/50 • Number of events 2 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
4.3%
2/46 • Number of events 2 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/43 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
4.5%
2/44 • Number of events 2 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
4.4%
2/45 • Number of events 2 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
|
Nervous system disorders
Psychiatric disorders
|
0.00%
0/50 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/46 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
4.7%
2/43 • Number of events 3 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/44 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/45 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders
|
4.0%
2/50 • Number of events 2 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
2.2%
1/46 • Number of events 2 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
4.7%
2/43 • Number of events 2 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/44 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/45 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous
|
28.0%
14/50 • Number of events 26 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
8.7%
4/46 • Number of events 7 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
14.0%
6/43 • Number of events 8 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
15.9%
7/44 • Number of events 17 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
17.8%
8/45 • Number of events 10 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
4.0%
2/50 • Number of events 2 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
2.2%
1/46 • Number of events 1 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/43 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/44 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/45 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
16.0%
8/50 • Number of events 16 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
6.5%
3/46 • Number of events 4 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
7.0%
3/43 • Number of events 3 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
9.1%
4/44 • Number of events 5 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
11.1%
5/45 • Number of events 5 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
|
Vascular disorders
Vascular disorders
|
0.00%
0/50 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
4.3%
2/46 • Number of events 2 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/43 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
2.3%
1/44 • Number of events 1 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/45 • The duration of the 12-week treatment period
All subjects randomized to treatment were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each weekly visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60