Trial Outcomes & Findings for Safety and Efficacy Trial of HP802-247 in the Treatment of Chronic Venous Leg Ulcers (NCT NCT01853384)
NCT ID: NCT01853384
Last Updated: 2016-10-03
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, using a laser-based wound imaging system in conjunction with software to measure area. Following initial closure subjects returned for four weekly visits to confirm wound closure. Wounds that remained closed for four weeks were classified as confirmed closures; if a wound opened at any of the 4 visits it was not considered to have closed. For subjects who dropped from the study prior to the end of treatment, their remaining visit values were imputed using LOCF; wound status of closed was not imputed.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
252 participants
Primary outcome timeframe
Weekly, over 12 Weeks or until wound closure, which ever occurred first
Results posted on
2016-10-03
Participant Flow
Subjects were screened at 47 sites in the EU \[Belgium (3), Czech Republic (8), Germany (15), Hungary (8), Poland (13)\] between January 10, 2014 and November 27, 2014; 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. After completion of the treatment period, subjects entered a three-month follow up period.
Participant milestones
| Measure |
HP802-247 Plus Compression Therapy
HP802-247 (fibrinogen solution \& thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days for up to 12 weeks or wound closure, which ever occurred first. Subjects randomized to HP802-247 will receive Vehicle on alternate weeks.
HP802-247: Study Dosage / Usage: 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days.
|
HP802-247 Vehicle Plus Compression Therapy
fibrinogen solution \& thrombin solution without cells. Subjects randomized to HP802-247 Vehicle will receive Vehicle weekly for up to 12 weeks or wound closure, which ever occurred first.
HP802-247 Vehicle: HP802-247 Vehicle consists of two separate components, a fibrinogen solution (Component 1) and a cell free thrombin solution which is identical to Component 2 except that no keratinocytes and no fibroblasts are present. A single dose is created when combined on the wound surface.
|
|---|---|---|
|
Randomized
STARTED
|
131
|
121
|
|
Randomized
COMPLETED
|
69
|
75
|
|
Randomized
NOT COMPLETED
|
62
|
46
|
|
Enrolled in Follow up Period
STARTED
|
96
|
94
|
|
Enrolled in Follow up Period
Not Enrolled in Follow-up
|
35
|
27
|
|
Enrolled in Follow up Period
COMPLETED
|
96
|
94
|
|
Enrolled in Follow up Period
NOT COMPLETED
|
0
|
0
|
|
Completed Follow up Visit 1
STARTED
|
96
|
94
|
|
Completed Follow up Visit 1
COMPLETED
|
82
|
85
|
|
Completed Follow up Visit 1
NOT COMPLETED
|
14
|
9
|
|
Completed Follow up Visit 2
STARTED
|
96
|
94
|
|
Completed Follow up Visit 2
COMPLETED
|
93
|
91
|
|
Completed Follow up Visit 2
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
HP802-247 Plus Compression Therapy
HP802-247 (fibrinogen solution \& thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days for up to 12 weeks or wound closure, which ever occurred first. Subjects randomized to HP802-247 will receive Vehicle on alternate weeks.
HP802-247: Study Dosage / Usage: 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days.
|
HP802-247 Vehicle Plus Compression Therapy
fibrinogen solution \& thrombin solution without cells. Subjects randomized to HP802-247 Vehicle will receive Vehicle weekly for up to 12 weeks or wound closure, which ever occurred first.
HP802-247 Vehicle: HP802-247 Vehicle consists of two separate components, a fibrinogen solution (Component 1) and a cell free thrombin solution which is identical to Component 2 except that no keratinocytes and no fibroblasts are present. A single dose is created when combined on the wound surface.
|
|---|---|---|
|
Randomized
Adverse Event
|
5
|
3
|
|
Randomized
Death
|
1
|
2
|
|
Randomized
Lost to Follow-up
|
1
|
1
|
|
Randomized
Withdrawal by Subject
|
5
|
3
|
|
Randomized
Sponsor Decision
|
47
|
34
|
|
Randomized
Other
|
3
|
3
|
|
Completed Follow up Visit 1
Early Termination
|
13
|
9
|
|
Completed Follow up Visit 1
Withdrawal by Subject
|
1
|
0
|
|
Completed Follow up Visit 2
Adverse Event
|
1
|
0
|
|
Completed Follow up Visit 2
Withdrawal by Subject
|
1
|
2
|
|
Completed Follow up Visit 2
Death
|
1
|
0
|
|
Completed Follow up Visit 2
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Safety and Efficacy Trial of HP802-247 in the Treatment of Chronic Venous Leg Ulcers
Baseline characteristics by cohort
| Measure |
HP802-247 Plus Compression Therapy
n=131 Participants
HP802-247 (fibrinogen solution \& thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days for up to 12 weeks or wound closure, which ever occurred first. Subjects randomized to HP802-247 will receive Vehicle on alternate weeks.
HP802-247: Study Dosage / Usage: 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days.
|
HP802-247 Vehicle Plus Compression Therapy
n=121 Participants
fibrinogen solution \& thrombin solution without cells. Subjects randomized to HP802-247 Vehicle will receive Vehicle weekly for up to 12 weeks or wound closure, which ever occurred first.
HP802-247 Vehicle: HP802-247 Vehicle consists of two separate components, a fibrinogen solution (Component 1) and a cell free thrombin solution which is identical to Component 2 except that no keratinocytes and no fibroblasts are present. A single dose is created when combined on the wound surface.
|
Total
n=252 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.6 years
n=5 Participants
|
68.1 years
n=7 Participants
|
66.8 years
n=5 Participants
|
|
Age, Customized
18-39 years
|
6 participants
n=5 Participants
|
3 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Age, Customized
40-49 years
|
6 participants
n=5 Participants
|
3 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Age, Customized
50-59 years
|
26 participants
n=5 Participants
|
20 participants
n=7 Participants
|
46 participants
n=5 Participants
|
|
Age, Customized
60-69 years
|
40 participants
n=5 Participants
|
40 participants
n=7 Participants
|
80 participants
n=5 Participants
|
|
Age, Customized
70+ years
|
53 participants
n=5 Participants
|
55 participants
n=7 Participants
|
108 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
76 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
139 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
55 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
113 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
129 Participants
n=5 Participants
|
120 Participants
n=7 Participants
|
249 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
131 Participants
n=5 Participants
|
121 Participants
n=7 Participants
|
252 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Weekly, over 12 Weeks or until wound closure, which ever occurred firstPopulation: ITT Populations: Subjects who received at least one dose of test article.
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. Following initial closure subjects returned for four weekly visits to confirm wound closure. Wounds that remained closed for four weeks were classified as confirmed closures; if a wound opened at any of the 4 visits it was not considered to have closed. For subjects who dropped from the study prior to the end of treatment, their remaining visit values were imputed using LOCF; wound status of closed was not imputed.
Outcome measures
| Measure |
HP802-247 Plus Compression Therapy
n=131 Participants
HP802-247 (fibrinogen solution \& thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days for up to 12 weeks or wound closure, which ever occurred first. Subjects randomized to HP802-247 will receive Vehicle on alternate weeks.
HP802-247: Study Dosage / Usage: 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days.
|
HP802-247 Vehicle Plus Compression Therapy
n=121 Participants
fibrinogen solution \& thrombin solution without cells. Subjects randomized to HP802-247 Vehicle will receive Vehicle weekly for up to 12 weeks or wound closure, which ever occurred first.
HP802-247 Vehicle: HP802-247 Vehicle consists of two separate components, a fibrinogen solution (Component 1) and a cell free thrombin solution which is identical to Component 2 except that no keratinocytes and no fibroblasts are present. A single dose is created when combined on the wound surface.
|
|---|---|---|
|
Compare the Treatment Groups for the Number of Subjects With Complete Wound Closure Over the 12-Week Treatment Period From Baseline
Wounds Closed
|
61 participants
|
61 participants
|
|
Compare the Treatment Groups for the Number of Subjects With Complete Wound Closure Over the 12-Week Treatment Period From Baseline
Wounds Not Closed
|
70 participants
|
60 participants
|
SECONDARY outcome
Timeframe: 12 WeeksPopulation: ITT Populations: Subjects who received at least one dose of test article. Data were analyzed using the Cox Proportional hazard procedure, with significance being at P \< 0.05.
This key secondary outcome was based on a Cox Proportional Hazard Analysis.
Outcome measures
| Measure |
HP802-247 Plus Compression Therapy
n=131 Participants
HP802-247 (fibrinogen solution \& thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days for up to 12 weeks or wound closure, which ever occurred first. Subjects randomized to HP802-247 will receive Vehicle on alternate weeks.
HP802-247: Study Dosage / Usage: 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days.
|
HP802-247 Vehicle Plus Compression Therapy
n=121 Participants
fibrinogen solution \& thrombin solution without cells. Subjects randomized to HP802-247 Vehicle will receive Vehicle weekly for up to 12 weeks or wound closure, which ever occurred first.
HP802-247 Vehicle: HP802-247 Vehicle consists of two separate components, a fibrinogen solution (Component 1) and a cell free thrombin solution which is identical to Component 2 except that no keratinocytes and no fibroblasts are present. A single dose is created when combined on the wound surface.
|
|---|---|---|
|
Compare the Efficacy of the Treatment Groups in Achieving Complete Wound Closure, Based on Time in Days to Closure Over the 12-Week Treatment Period From Baseline.
|
57.0 days
Interval 8.0 to 115.0
|
50.0 days
Interval 6.0 to 134.0
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: ITT Populations: Subjects who received at least one dose of test article. Data were analyzed using Kaplan-Meier Survival analysis, with significance being at P \< 0.05.
This key secondary outcome was based on a Kaplan-Meier Survival analysis.
Outcome measures
| Measure |
HP802-247 Plus Compression Therapy
n=131 Participants
HP802-247 (fibrinogen solution \& thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days for up to 12 weeks or wound closure, which ever occurred first. Subjects randomized to HP802-247 will receive Vehicle on alternate weeks.
HP802-247: Study Dosage / Usage: 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days.
|
HP802-247 Vehicle Plus Compression Therapy
n=121 Participants
fibrinogen solution \& thrombin solution without cells. Subjects randomized to HP802-247 Vehicle will receive Vehicle weekly for up to 12 weeks or wound closure, which ever occurred first.
HP802-247 Vehicle: HP802-247 Vehicle consists of two separate components, a fibrinogen solution (Component 1) and a cell free thrombin solution which is identical to Component 2 except that no keratinocytes and no fibroblasts are present. A single dose is created when combined on the wound surface.
|
|---|---|---|
|
Compare the Efficacy of the Treatment Groups in Achieving Complete Wound Closure, Based on Median Time (Days) to Closure Over the 12-Week Treatment Period From Baseline.
|
64 days
Interval 57.0 to 78.0
|
57 days
Interval 50.0 to 71.0
|
SECONDARY outcome
Timeframe: Weekly, over the 12 week treatment period, or until wound closure, which ever occurred firstPopulation: ITT Populations: Subjects who received at least one dose of test article. Analysis was by the Cochrane Mantel Haenszel (CMH) test, adjusted for sites, with significance being at P \< 0.05
For subjects who dropped from the study, their remaining visit values were imputed using LOCF. Treatment groups were compared for percentage of participants with closed wounds at each treatment visit.
Outcome measures
| Measure |
HP802-247 Plus Compression Therapy
n=131 Participants
HP802-247 (fibrinogen solution \& thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days for up to 12 weeks or wound closure, which ever occurred first. Subjects randomized to HP802-247 will receive Vehicle on alternate weeks.
HP802-247: Study Dosage / Usage: 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days.
|
HP802-247 Vehicle Plus Compression Therapy
n=121 Participants
fibrinogen solution \& thrombin solution without cells. Subjects randomized to HP802-247 Vehicle will receive Vehicle weekly for up to 12 weeks or wound closure, which ever occurred first.
HP802-247 Vehicle: HP802-247 Vehicle consists of two separate components, a fibrinogen solution (Component 1) and a cell free thrombin solution which is identical to Component 2 except that no keratinocytes and no fibroblasts are present. A single dose is created when combined on the wound surface.
|
|---|---|---|
|
Compare the Treatment Groups for the Proportion of Subjects With Wound Closure at Each of the 12-Week Treatment Period From Baseline
Treatment Week 12
|
48.1 percentage of participants
|
53.7 percentage of participants
|
|
Compare the Treatment Groups for the Proportion of Subjects With Wound Closure at Each of the 12-Week Treatment Period From Baseline
Baseline
|
0 percentage of participants
|
0 percentage of participants
|
|
Compare the Treatment Groups for the Proportion of Subjects With Wound Closure at Each of the 12-Week Treatment Period From Baseline
Treatment Week 01
|
2.3 percentage of participants
|
3.3 percentage of participants
|
|
Compare the Treatment Groups for the Proportion of Subjects With Wound Closure at Each of the 12-Week Treatment Period From Baseline
Treatment Week 02
|
8.4 percentage of participants
|
7.4 percentage of participants
|
|
Compare the Treatment Groups for the Proportion of Subjects With Wound Closure at Each of the 12-Week Treatment Period From Baseline
Treatment Week 03
|
13.7 percentage of participants
|
18.2 percentage of participants
|
|
Compare the Treatment Groups for the Proportion of Subjects With Wound Closure at Each of the 12-Week Treatment Period From Baseline
Treatment Week 04
|
22.1 percentage of participants
|
25.6 percentage of participants
|
|
Compare the Treatment Groups for the Proportion of Subjects With Wound Closure at Each of the 12-Week Treatment Period From Baseline
Treatment Week 05
|
26.7 percentage of participants
|
33.9 percentage of participants
|
|
Compare the Treatment Groups for the Proportion of Subjects With Wound Closure at Each of the 12-Week Treatment Period From Baseline
Treatment Week 06
|
29.8 percentage of participants
|
38.0 percentage of participants
|
|
Compare the Treatment Groups for the Proportion of Subjects With Wound Closure at Each of the 12-Week Treatment Period From Baseline
Treatment Week 07
|
32.8 percentage of participants
|
39.7 percentage of participants
|
|
Compare the Treatment Groups for the Proportion of Subjects With Wound Closure at Each of the 12-Week Treatment Period From Baseline
Treatment Week 08
|
37.4 percentage of participants
|
39.7 percentage of participants
|
|
Compare the Treatment Groups for the Proportion of Subjects With Wound Closure at Each of the 12-Week Treatment Period From Baseline
Treatment Week 09
|
38.9 percentage of participants
|
43.8 percentage of participants
|
|
Compare the Treatment Groups for the Proportion of Subjects With Wound Closure at Each of the 12-Week Treatment Period From Baseline
Treatment Week 10
|
40.5 percentage of participants
|
46.3 percentage of participants
|
|
Compare the Treatment Groups for the Proportion of Subjects With Wound Closure at Each of the 12-Week Treatment Period From Baseline
Treatment Week 11
|
41.2 percentage of participants
|
47.9 percentage of participants
|
|
Compare the Treatment Groups for the Proportion of Subjects With Wound Closure at Each of the 12-Week Treatment Period From Baseline
Week 12 - Primary Endpoint
|
46.6 percentage of participants
|
50.4 percentage of participants
|
SECONDARY outcome
Timeframe: Target ulcer status observed at two (visit 1) and three (visit 2) months following initial ulcer closure.Population: Due to study termination the data available to assess durability of closure were limited to only the subjects who completed at least one of the follow-up visits. Participants who had CLOSED wounds at completion of treatment; 103 subjects (HP802-247: 49; Vehicle: 54) completed Visit 18, 114 subjects (HP802-247: 57; Vehicle: 57) completed Visit 19
Subjects who completed the treatment period with confirmed wound closure were followed in the post-treatment period for a further two months to determine their closed wound status (remained closed/reopened), giving a measure of persistence of wound closure following completion of treatment.
Outcome measures
| Measure |
HP802-247 Plus Compression Therapy
n=134 Participants
HP802-247 (fibrinogen solution \& thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days for up to 12 weeks or wound closure, which ever occurred first. Subjects randomized to HP802-247 will receive Vehicle on alternate weeks.
HP802-247: Study Dosage / Usage: 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days.
|
HP802-247 Vehicle Plus Compression Therapy
n=132 Participants
fibrinogen solution \& thrombin solution without cells. Subjects randomized to HP802-247 Vehicle will receive Vehicle weekly for up to 12 weeks or wound closure, which ever occurred first.
HP802-247 Vehicle: HP802-247 Vehicle consists of two separate components, a fibrinogen solution (Component 1) and a cell free thrombin solution which is identical to Component 2 except that no keratinocytes and no fibroblasts are present. A single dose is created when combined on the wound surface.
|
|---|---|---|
|
Number of Subjects With Durable Wound Healing Over the 3 Months Following Complete Wound Closure
Follow-up Visit 1 (wounds remained closed)
|
45 participants
|
52 participants
|
|
Number of Subjects With Durable Wound Healing Over the 3 Months Following Complete Wound Closure
Follow-up Visit 1 (wounds reopened)
|
4 participants
|
2 participants
|
|
Number of Subjects With Durable Wound Healing Over the 3 Months Following Complete Wound Closure
Follow-up Visit 2 (wounds remained closed)
|
51 participants
|
47 participants
|
|
Number of Subjects With Durable Wound Healing Over the 3 Months Following Complete Wound Closure
Follow-up Visit 2 (wounds reopened)
|
6 participants
|
10 participants
|
SECONDARY outcome
Timeframe: Baseline and 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.
Outcome measures
| Measure |
HP802-247 Plus Compression Therapy
n=131 Participants
HP802-247 (fibrinogen solution \& thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days for up to 12 weeks or wound closure, which ever occurred first. Subjects randomized to HP802-247 will receive Vehicle on alternate weeks.
HP802-247: Study Dosage / Usage: 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days.
|
HP802-247 Vehicle Plus Compression Therapy
n=121 Participants
fibrinogen solution \& thrombin solution without cells. Subjects randomized to HP802-247 Vehicle will receive Vehicle weekly for up to 12 weeks or wound closure, which ever occurred first.
HP802-247 Vehicle: HP802-247 Vehicle consists of two separate components, a fibrinogen solution (Component 1) and a cell free thrombin solution which is identical to Component 2 except that no keratinocytes and no fibroblasts are present. A single dose is created when combined on the wound surface.
|
|---|---|---|
|
Change From Baseline in Pain Associated With the Target Wound at Each of the 12 Double Blind Treatment Weeks
Week 10
|
-18.9 mm
Standard Error 2.0
|
-18.4 mm
Standard Error 2.1
|
|
Change From Baseline in Pain Associated With the Target Wound at Each of the 12 Double Blind Treatment Weeks
Week 11
|
-19.4 mm
Standard Error 2.0
|
-19.7 mm
Standard Error 2.1
|
|
Change From Baseline in Pain Associated With the Target Wound at Each of the 12 Double Blind Treatment Weeks
Baseline
|
29.40 mm
Standard Error 28.5
|
26.30 mm
Standard Error 28.3
|
|
Change From Baseline in Pain Associated With the Target Wound at Each of the 12 Double Blind Treatment Weeks
Week 01
|
-8.6 mm
Standard Error 2
|
-7.5 mm
Standard Error 2.1
|
|
Change From Baseline in Pain Associated With the Target Wound at Each of the 12 Double Blind Treatment Weeks
Week 02
|
-10.4 mm
Standard Error 2.2
|
-11.0 mm
Standard Error 2.3
|
|
Change From Baseline in Pain Associated With the Target Wound at Each of the 12 Double Blind Treatment Weeks
Week 03
|
-14.0 mm
Standard Error 2.3
|
-10.7 mm
Standard Error 2.4
|
|
Change From Baseline in Pain Associated With the Target Wound at Each of the 12 Double Blind Treatment Weeks
Week 04
|
-14.3 mm
Standard Error 2.3
|
-12.1 mm
Standard Error 2.3
|
|
Change From Baseline in Pain Associated With the Target Wound at Each of the 12 Double Blind Treatment Weeks
Week 05
|
-17.2 mm
Standard Error 2.1
|
-13.6 mm
Standard Error 2.2
|
|
Change From Baseline in Pain Associated With the Target Wound at Each of the 12 Double Blind Treatment Weeks
Week 06
|
-17.8 mm
Standard Error 2.2
|
-15.4 mm
Standard Error 2.2
|
|
Change From Baseline in Pain Associated With the Target Wound at Each of the 12 Double Blind Treatment Weeks
Week 07
|
-18.5 mm
Standard Error 2.0
|
-17.5 mm
Standard Error 2.1
|
|
Change From Baseline in Pain Associated With the Target Wound at Each of the 12 Double Blind Treatment Weeks
Week 08
|
-20.0 mm
Standard Error 2.0
|
-17.1 mm
Standard Error 2.1
|
|
Change From Baseline in Pain Associated With the Target Wound at Each of the 12 Double Blind Treatment Weeks
Week 09
|
-19.7 mm
Standard Error 2.1
|
-17.9 mm
Standard Error 2.1
|
|
Change From Baseline in Pain Associated With the Target Wound at Each of the 12 Double Blind Treatment Weeks
Week 12
|
-20.0 mm
Standard Error 2.0
|
-20.1 mm
Standard Error 2.0
|
SECONDARY outcome
Timeframe: Baseline and 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 leg pain were 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.
Outcome measures
| Measure |
HP802-247 Plus Compression Therapy
n=131 Participants
HP802-247 (fibrinogen solution \& thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days for up to 12 weeks or wound closure, which ever occurred first. Subjects randomized to HP802-247 will receive Vehicle on alternate weeks.
HP802-247: Study Dosage / Usage: 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days.
|
HP802-247 Vehicle Plus Compression Therapy
n=121 Participants
fibrinogen solution \& thrombin solution without cells. Subjects randomized to HP802-247 Vehicle will receive Vehicle weekly for up to 12 weeks or wound closure, which ever occurred first.
HP802-247 Vehicle: HP802-247 Vehicle consists of two separate components, a fibrinogen solution (Component 1) and a cell free thrombin solution which is identical to Component 2 except that no keratinocytes and no fibroblasts are present. A single dose is created when combined on the wound surface.
|
|---|---|---|
|
Change From Baseline in Pain Associated With the Target Leg at Each of the 12 Double Blind Treatment Weeks
Baseline
|
24.18 mm
Standard Error 27.0
|
22.35 mm
Standard Error 16.0
|
|
Change From Baseline in Pain Associated With the Target Leg at Each of the 12 Double Blind Treatment Weeks
Week 01
|
-4.1 mm
Standard Error 2.3
|
-4.9 mm
Standard Error 2.4
|
|
Change From Baseline in Pain Associated With the Target Leg at Each of the 12 Double Blind Treatment Weeks
Week 02
|
-2.2 mm
Standard Error 2.3
|
-1.3 mm
Standard Error 2.4
|
|
Change From Baseline in Pain Associated With the Target Leg at Each of the 12 Double Blind Treatment Weeks
Week 03
|
-9.2 mm
Standard Error 2.2
|
-5.3 mm
Standard Error 2.3
|
|
Change From Baseline in Pain Associated With the Target Leg at Each of the 12 Double Blind Treatment Weeks
Week 04
|
-10.1 mm
Standard Error 2.2
|
-8.8 mm
Standard Error 2.2
|
|
Change From Baseline in Pain Associated With the Target Leg at Each of the 12 Double Blind Treatment Weeks
Week 05
|
-9.7 mm
Standard Error 2.3
|
-8.6 mm
Standard Error 2.3
|
|
Change From Baseline in Pain Associated With the Target Leg at Each of the 12 Double Blind Treatment Weeks
Week 06
|
-12.2 mm
Standard Error 2.0
|
-9.1 mm
Standard Error 2.1
|
|
Change From Baseline in Pain Associated With the Target Leg at Each of the 12 Double Blind Treatment Weeks
Week 07
|
-13.1 mm
Standard Error 2.2
|
-8.9 mm
Standard Error 2.2
|
|
Change From Baseline in Pain Associated With the Target Leg at Each of the 12 Double Blind Treatment Weeks
Week 08
|
-14.2 mm
Standard Error 2.1
|
-9.0 mm
Standard Error 2.1
|
|
Change From Baseline in Pain Associated With the Target Leg at Each of the 12 Double Blind Treatment Weeks
Week 09
|
-10.1 mm
Standard Error 2.2
|
-6.3 mm
Standard Error 2.3
|
|
Change From Baseline in Pain Associated With the Target Leg at Each of the 12 Double Blind Treatment Weeks
Week 10
|
-12.7 mm
Standard Error 2.1
|
-11.1 mm
Standard Error 2.2
|
|
Change From Baseline in Pain Associated With the Target Leg at Each of the 12 Double Blind Treatment Weeks
Week 11
|
-12.9 mm
Standard Error 2.0
|
-11.8 mm
Standard Error 2.1
|
|
Change From Baseline in Pain Associated With the Target Leg at Each of the 12 Double Blind Treatment Weeks
Week 12
|
-14.3 mm
Standard Error 2.0
|
-12.2 mm
Standard Error 2.1
|
Adverse Events
HP802-247 Plus Compression Therapy
Serious events: 5 serious events
Other events: 60 other events
Deaths: 0 deaths
HP802-247 Vehicle Plus Compression Therapy
Serious events: 12 serious events
Other events: 64 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
HP802-247 Plus Compression Therapy
n=131 participants at risk
HP802-247 (fibrinogen solution \& thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days for up to 12 weeks or wound closure, which ever occurred first. Subjects randomized to HP802-247 will receive Vehicle on alternate weeks.
HP802-247: Study Dosage / Usage: 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days.
|
HP802-247 Vehicle Plus Compression Therapy
n=121 participants at risk
fibrinogen solution \& thrombin solution without cells. Subjects randomized to HP802-247 Vehicle will receive Vehicle weekly for up to 12 weeks or wound closure, which ever occurred first.
HP802-247 Vehicle: HP802-247 Vehicle consists of two separate components, a fibrinogen solution (Component 1) and a cell free thrombin solution which is identical to Component 2 except that no keratinocytes and no fibroblasts are present. A single dose is created when combined on the wound surface.
|
|---|---|---|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/131 • Up to 19 Weeks or subjects who completed 12 weeks of treatment and the post-treatment follow up. For subjects who had wound closure, collection time included the treatment period and the post-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.
|
0.83%
1/121 • Number of events 1 • Up to 19 Weeks or subjects who completed 12 weeks of treatment and the post-treatment follow up. For subjects who had wound closure, collection time included the treatment period and the post-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
Arrhythmia
|
0.76%
1/131 • Number of events 1 • Up to 19 Weeks or subjects who completed 12 weeks of treatment and the post-treatment follow up. For subjects who had wound closure, collection time included the treatment period and the post-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%
0/121 • Up to 19 Weeks or subjects who completed 12 weeks of treatment and the post-treatment follow up. For subjects who had wound closure, collection time included the treatment period and the post-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 arrest
|
0.76%
1/131 • Number of events 1 • Up to 19 Weeks or subjects who completed 12 weeks of treatment and the post-treatment follow up. For subjects who had wound closure, collection time included the treatment period and the post-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%
0/121 • Up to 19 Weeks or subjects who completed 12 weeks of treatment and the post-treatment follow up. For subjects who had wound closure, collection time included the treatment period and the post-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
|
0.00%
0/131 • Up to 19 Weeks or subjects who completed 12 weeks of treatment and the post-treatment follow up. For subjects who had wound closure, collection time included the treatment period and the post-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.
|
0.83%
1/121 • Number of events 1 • Up to 19 Weeks or subjects who completed 12 weeks of treatment and the post-treatment follow up. For subjects who had wound closure, collection time included the treatment period and the post-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
Small intestinal obstruction
|
0.00%
0/131 • Up to 19 Weeks or subjects who completed 12 weeks of treatment and the post-treatment follow up. For subjects who had wound closure, collection time included the treatment period and the post-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.
|
0.83%
1/121 • Number of events 1 • Up to 19 Weeks or subjects who completed 12 weeks of treatment and the post-treatment follow up. For subjects who had wound closure, collection time included the treatment period and the post-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
Oedema peripheral
|
0.00%
0/131 • Up to 19 Weeks or subjects who completed 12 weeks of treatment and the post-treatment follow up. For subjects who had wound closure, collection time included the treatment period and the post-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.
|
0.83%
1/121 • Number of events 2 • Up to 19 Weeks or subjects who completed 12 weeks of treatment and the post-treatment follow up. For subjects who had wound closure, collection time included the treatment period and the post-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
Erysipelas
|
0.00%
0/131 • Up to 19 Weeks or subjects who completed 12 weeks of treatment and the post-treatment follow up. For subjects who had wound closure, collection time included the treatment period and the post-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.
|
0.83%
1/121 • Number of events 1 • Up to 19 Weeks or subjects who completed 12 weeks of treatment and the post-treatment follow up. For subjects who had wound closure, collection time included the treatment period and the post-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
Gangrene
|
0.76%
1/131 • Number of events 1 • Up to 19 Weeks or subjects who completed 12 weeks of treatment and the post-treatment follow up. For subjects who had wound closure, collection time included the treatment period and the post-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%
0/121 • Up to 19 Weeks or subjects who completed 12 weeks of treatment and the post-treatment follow up. For subjects who had wound closure, collection time included the treatment period and the post-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
|
0.00%
0/131 • Up to 19 Weeks or subjects who completed 12 weeks of treatment and the post-treatment follow up. For subjects who had wound closure, collection time included the treatment period and the post-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.
|
0.83%
1/121 • Number of events 1 • Up to 19 Weeks or subjects who completed 12 weeks of treatment and the post-treatment follow up. For subjects who had wound closure, collection time included the treatment period and the post-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 sepsis
|
0.00%
0/131 • Up to 19 Weeks or subjects who completed 12 weeks of treatment and the post-treatment follow up. For subjects who had wound closure, collection time included the treatment period and the post-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.
|
0.83%
1/121 • Number of events 1 • Up to 19 Weeks or subjects who completed 12 weeks of treatment and the post-treatment follow up. For subjects who had wound closure, collection time included the treatment period and the post-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
Humerus fracture
|
0.76%
1/131 • Number of events 1 • Up to 19 Weeks or subjects who completed 12 weeks of treatment and the post-treatment follow up. For subjects who had wound closure, collection time included the treatment period and the post-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%
0/121 • Up to 19 Weeks or subjects who completed 12 weeks of treatment and the post-treatment follow up. For subjects who had wound closure, collection time included the treatment period and the post-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
Lower limb fracture
|
0.76%
1/131 • Number of events 1 • Up to 19 Weeks or subjects who completed 12 weeks of treatment and the post-treatment follow up. For subjects who had wound closure, collection time included the treatment period and the post-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%
0/121 • Up to 19 Weeks or subjects who completed 12 weeks of treatment and the post-treatment follow up. For subjects who had wound closure, collection time included the treatment period and the post-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
Multiple injuries
|
0.00%
0/131 • Up to 19 Weeks or subjects who completed 12 weeks of treatment and the post-treatment follow up. For subjects who had wound closure, collection time included the treatment period and the post-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.
|
1.7%
2/121 • Number of events 2 • Up to 19 Weeks or subjects who completed 12 weeks of treatment and the post-treatment follow up. For subjects who had wound closure, collection time included the treatment period and the post-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
Traumatic haematoma
|
0.00%
0/131 • Up to 19 Weeks or subjects who completed 12 weeks of treatment and the post-treatment follow up. For subjects who had wound closure, collection time included the treatment period and the post-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.
|
0.83%
1/121 • Number of events 1 • Up to 19 Weeks or subjects who completed 12 weeks of treatment and the post-treatment follow up. For subjects who had wound closure, collection time included the treatment period and the post-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)
Metastases to lung
|
0.76%
1/131 • Number of events 1 • Up to 19 Weeks or subjects who completed 12 weeks of treatment and the post-treatment follow up. For subjects who had wound closure, collection time included the treatment period and the post-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%
0/121 • Up to 19 Weeks or subjects who completed 12 weeks of treatment and the post-treatment follow up. For subjects who had wound closure, collection time included the treatment period and the post-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)
Vulval cancer
|
0.76%
1/131 • Number of events 1 • Up to 19 Weeks or subjects who completed 12 weeks of treatment and the post-treatment follow up. For subjects who had wound closure, collection time included the treatment period and the post-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%
0/121 • Up to 19 Weeks or subjects who completed 12 weeks of treatment and the post-treatment follow up. For subjects who had wound closure, collection time included the treatment period and the post-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.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.00%
0/131 • Up to 19 Weeks or subjects who completed 12 weeks of treatment and the post-treatment follow up. For subjects who had wound closure, collection time included the treatment period and the post-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.
|
0.83%
1/121 • Number of events 1 • Up to 19 Weeks or subjects who completed 12 weeks of treatment and the post-treatment follow up. For subjects who had wound closure, collection time included the treatment period and the post-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
Dermatitis contact
|
0.00%
0/131 • Up to 19 Weeks or subjects who completed 12 weeks of treatment and the post-treatment follow up. For subjects who had wound closure, collection time included the treatment period and the post-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.
|
0.83%
1/121 • Number of events 1 • Up to 19 Weeks or subjects who completed 12 weeks of treatment and the post-treatment follow up. For subjects who had wound closure, collection time included the treatment period and the post-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
Pemphigoid
|
0.00%
0/131 • Up to 19 Weeks or subjects who completed 12 weeks of treatment and the post-treatment follow up. For subjects who had wound closure, collection time included the treatment period and the post-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.
|
0.83%
1/121 • Number of events 1 • Up to 19 Weeks or subjects who completed 12 weeks of treatment and the post-treatment follow up. For subjects who had wound closure, collection time included the treatment period and the post-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
Purpura
|
0.00%
0/131 • Up to 19 Weeks or subjects who completed 12 weeks of treatment and the post-treatment follow up. For subjects who had wound closure, collection time included the treatment period and the post-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.
|
0.83%
1/121 • Number of events 1 • Up to 19 Weeks or subjects who completed 12 weeks of treatment and the post-treatment follow up. For subjects who had wound closure, collection time included the treatment period and the post-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
|
0.76%
1/131 • Number of events 1 • Up to 19 Weeks or subjects who completed 12 weeks of treatment and the post-treatment follow up. For subjects who had wound closure, collection time included the treatment period and the post-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%
0/121 • Up to 19 Weeks or subjects who completed 12 weeks of treatment and the post-treatment follow up. For subjects who had wound closure, collection time included the treatment period and the post-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
Stasis dermatitis
|
0.00%
0/131 • Up to 19 Weeks or subjects who completed 12 weeks of treatment and the post-treatment follow up. For subjects who had wound closure, collection time included the treatment period and the post-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.
|
0.83%
1/121 • Number of events 1 • Up to 19 Weeks or subjects who completed 12 weeks of treatment and the post-treatment follow up. For subjects who had wound closure, collection time included the treatment period and the post-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 |
HP802-247 Plus Compression Therapy
n=131 participants at risk
HP802-247 (fibrinogen solution \& thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days for up to 12 weeks or wound closure, which ever occurred first. Subjects randomized to HP802-247 will receive Vehicle on alternate weeks.
HP802-247: Study Dosage / Usage: 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days.
|
HP802-247 Vehicle Plus Compression Therapy
n=121 participants at risk
fibrinogen solution \& thrombin solution without cells. Subjects randomized to HP802-247 Vehicle will receive Vehicle weekly for up to 12 weeks or wound closure, which ever occurred first.
HP802-247 Vehicle: HP802-247 Vehicle consists of two separate components, a fibrinogen solution (Component 1) and a cell free thrombin solution which is identical to Component 2 except that no keratinocytes and no fibroblasts are present. A single dose is created when combined on the wound surface.
|
|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
3.8%
5/131 • Number of events 9 • Up to 19 Weeks or subjects who completed 12 weeks of treatment and the post-treatment follow up. For subjects who had wound closure, collection time included the treatment period and the post-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.
|
5.0%
6/121 • Number of events 8 • Up to 19 Weeks or subjects who completed 12 weeks of treatment and the post-treatment follow up. For subjects who had wound closure, collection time included the treatment period and the post-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
|
2.3%
3/131 • Number of events 3 • Up to 19 Weeks or subjects who completed 12 weeks of treatment and the post-treatment follow up. For subjects who had wound closure, collection time included the treatment period and the post-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.
|
7.4%
9/121 • Number of events 11 • Up to 19 Weeks or subjects who completed 12 weeks of treatment and the post-treatment follow up. For subjects who had wound closure, collection time included the treatment period and the post-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
|
11.5%
15/131 • Number of events 20 • Up to 19 Weeks or subjects who completed 12 weeks of treatment and the post-treatment follow up. For subjects who had wound closure, collection time included the treatment period and the post-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.
|
15.7%
19/121 • Number of events 23 • Up to 19 Weeks or subjects who completed 12 weeks of treatment and the post-treatment follow up. For subjects who had wound closure, collection time included the treatment period and the post-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
|
5.3%
7/131 • Number of events 9 • Up to 19 Weeks or subjects who completed 12 weeks of treatment and the post-treatment follow up. For subjects who had wound closure, collection time included the treatment period and the post-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.
|
4.1%
5/121 • Number of events 7 • Up to 19 Weeks or subjects who completed 12 weeks of treatment and the post-treatment follow up. For subjects who had wound closure, collection time included the treatment period and the post-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
|
13.7%
18/131 • Number of events 22 • Up to 19 Weeks or subjects who completed 12 weeks of treatment and the post-treatment follow up. For subjects who had wound closure, collection time included the treatment period and the post-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.
|
10.7%
13/121 • Number of events 13 • Up to 19 Weeks or subjects who completed 12 weeks of treatment and the post-treatment follow up. For subjects who had wound closure, collection time included the treatment period and the post-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
|
7.6%
10/131 • Number of events 12 • Up to 19 Weeks or subjects who completed 12 weeks of treatment and the post-treatment follow up. For subjects who had wound closure, collection time included the treatment period and the post-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.
|
5.0%
6/121 • Number of events 6 • Up to 19 Weeks or subjects who completed 12 weeks of treatment and the post-treatment follow up. For subjects who had wound closure, collection time included the treatment period and the post-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.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders
|
1.5%
2/131 • Number of events 2 • Up to 19 Weeks or subjects who completed 12 weeks of treatment and the post-treatment follow up. For subjects who had wound closure, collection time included the treatment period and the post-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.
|
3.3%
4/121 • Number of events 4 • Up to 19 Weeks or subjects who completed 12 weeks of treatment and the post-treatment follow up. For subjects who had wound closure, collection time included the treatment period and the post-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
|
6.9%
9/131 • Number of events 13 • Up to 19 Weeks or subjects who completed 12 weeks of treatment and the post-treatment follow up. For subjects who had wound closure, collection time included the treatment period and the post-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.
|
11.6%
14/121 • Number of events 19 • Up to 19 Weeks or subjects who completed 12 weeks of treatment and the post-treatment follow up. For subjects who had wound closure, collection time included the treatment period and the post-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
|
3.8%
5/131 • Number of events 6 • Up to 19 Weeks or subjects who completed 12 weeks of treatment and the post-treatment follow up. For subjects who had wound closure, collection time included the treatment period and the post-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.
|
9.9%
12/121 • Number of events 15 • Up to 19 Weeks or subjects who completed 12 weeks of treatment and the post-treatment follow up. For subjects who had wound closure, collection time included the treatment period and the post-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
|
1.5%
2/131 • Number of events 7 • Up to 19 Weeks or subjects who completed 12 weeks of treatment and the post-treatment follow up. For subjects who had wound closure, collection time included the treatment period and the post-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.
|
3.3%
4/121 • Number of events 4 • Up to 19 Weeks or subjects who completed 12 weeks of treatment and the post-treatment follow up. For subjects who had wound closure, collection time included the treatment period and the post-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 tissue disorders
|
22.9%
30/131 • Number of events 62 • Up to 19 Weeks or subjects who completed 12 weeks of treatment and the post-treatment follow up. For subjects who had wound closure, collection time included the treatment period and the post-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.
|
32.2%
39/121 • Number of events 87 • Up to 19 Weeks or subjects who completed 12 weeks of treatment and the post-treatment follow up. For subjects who had wound closure, collection time included the treatment period and the post-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
Dermatitis
|
3.1%
4/131 • Number of events 6 • Up to 19 Weeks or subjects who completed 12 weeks of treatment and the post-treatment follow up. For subjects who had wound closure, collection time included the treatment period and the post-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.
|
0.83%
1/121 • Number of events 2 • Up to 19 Weeks or subjects who completed 12 weeks of treatment and the post-treatment follow up. For subjects who had wound closure, collection time included the treatment period and the post-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
Erythema
|
3.1%
4/131 • Number of events 4 • Up to 19 Weeks or subjects who completed 12 weeks of treatment and the post-treatment follow up. For subjects who had wound closure, collection time included the treatment period and the post-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.
|
4.1%
5/121 • Number of events 6 • Up to 19 Weeks or subjects who completed 12 weeks of treatment and the post-treatment follow up. For subjects who had wound closure, collection time included the treatment period and the post-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 maceration
|
1.5%
2/131 • Number of events 3 • Up to 19 Weeks or subjects who completed 12 weeks of treatment and the post-treatment follow up. For subjects who had wound closure, collection time included the treatment period and the post-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.
|
5.8%
7/121 • Number of events 13 • Up to 19 Weeks or subjects who completed 12 weeks of treatment and the post-treatment follow up. For subjects who had wound closure, collection time included the treatment period and the post-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
|
13.0%
17/131 • Number of events 34 • Up to 19 Weeks or subjects who completed 12 weeks of treatment and the post-treatment follow up. For subjects who had wound closure, collection time included the treatment period and the post-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.
|
16.5%
20/121 • Number of events 37 • Up to 19 Weeks or subjects who completed 12 weeks of treatment and the post-treatment follow up. For subjects who had wound closure, collection time included the treatment period and the post-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
Venous ulcer pain
|
4.6%
6/131 • Number of events 6 • Up to 19 Weeks or subjects who completed 12 weeks of treatment and the post-treatment follow up. For subjects who had wound closure, collection time included the treatment period and the post-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.
|
2.5%
3/121 • Number of events 3 • Up to 19 Weeks or subjects who completed 12 weeks of treatment and the post-treatment follow up. For subjects who had wound closure, collection time included the treatment period and the post-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
|
3.8%
5/131 • Number of events 8 • Up to 19 Weeks or subjects who completed 12 weeks of treatment and the post-treatment follow up. For subjects who had wound closure, collection time included the treatment period and the post-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.
|
8.3%
10/121 • Number of events 11 • Up to 19 Weeks or subjects who completed 12 weeks of treatment and the post-treatment follow up. For subjects who had wound closure, collection time included the treatment period and the post-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
Hypertension
|
3.8%
5/131 • Number of events 8 • Up to 19 Weeks or subjects who completed 12 weeks of treatment and the post-treatment follow up. For subjects who had wound closure, collection time included the treatment period and the post-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.
|
5.8%
7/121 • Number of events 8 • Up to 19 Weeks or subjects who completed 12 weeks of treatment and the post-treatment follow up. For subjects who had wound closure, collection time included the treatment period and the post-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