Trial Outcomes & Findings for Study Investigating the Safety and Efficacy of HP802-247 in the Treatment of Venous Leg Ulcers >12 cm2 to ≤ 36 cm2 (NCT NCT01737762)

NCT ID: NCT01737762

Last Updated: 2017-07-26

Results Overview

Compare HP802-247 plus compression therapy against Vehicle plus compression therapy for proportion of subjects with complete wound closure over the 16-week treatment period from baseline.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 155 participants
• Primary outcome timeframe: 16 Weeks
• Results posted on: 2017-07-26

Participant Flow

Subjects were screened at 36 sites in the US and 3 in Canada; between November 30, 2012 and November 11, 2015; 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 HP802-247 (fibrinogen solution \& thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 solution) containing 0.5 x 106 cells per mL every 14 days.	Vehicle Vehicle Control(fibrinogen solution \& thrombin solution without cells)
Overall Study STARTED	77	78
Overall Study COMPLETED	57	61
Overall Study NOT COMPLETED	20	17

Reasons for withdrawal

Measure	HP802-247 HP802-247 (fibrinogen solution \& thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 solution) containing 0.5 x 106 cells per mL every 14 days.	Vehicle Vehicle Control(fibrinogen solution \& thrombin solution without cells)
Overall Study Adverse Event	2	2
Overall Study Lost to Follow-up	1	0
Overall Study Withdrawal by Subject	2	2
Overall Study Progressive disease	1	2
Overall Study Physician Decision	1	1
Overall Study Moved from area	2	1
Overall Study Trial termination	11	9

Baseline Characteristics

Study Investigating the Safety and Efficacy of HP802-247 in the Treatment of Venous Leg Ulcers >12 cm2 to ≤ 36 cm2

Baseline characteristics by cohort

Measure	HP802-247 n=69 Participants HP802-247 (fibrinogen solution \& thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 solution) containing 0.5 x 106 cells per mL every 14 days.	Vehicle n=70 Participants Vehicle Control(fibrinogen solution \& thrombin solution without cells)	Total n=139 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	37 Participants n=5 Participants	44 Participants n=7 Participants	81 Participants n=5 Participants
Age, Categorical >=65 years	32 Participants n=5 Participants	26 Participants n=7 Participants	58 Participants n=5 Participants
Age, Continuous	62.4 years STANDARD_DEVIATION 15.1 • n=5 Participants	61.0 years STANDARD_DEVIATION 12.1 • n=7 Participants	61.7 years STANDARD_DEVIATION 13.6 • n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants	32 Participants n=7 Participants	60 Participants n=5 Participants
Sex: Female, Male Male	41 Participants n=5 Participants	38 Participants n=7 Participants	79 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	17 Participants n=5 Participants	15 Participants n=7 Participants	32 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	52 Participants n=5 Participants	55 Participants n=7 Participants	107 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 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	13 Participants n=5 Participants	11 Participants n=7 Participants	24 Participants n=5 Participants
Race (NIH/OMB) White	51 Participants n=5 Participants	58 Participants n=7 Participants	109 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	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment Canada	4 participants n=5 Participants	3 participants n=7 Participants	7 participants n=5 Participants
Region of Enrollment United States	65 participants n=5 Participants	67 participants n=7 Participants	132 participants n=5 Participants

PRIMARY outcome

Timeframe: 16 Weeks

Compare HP802-247 plus compression therapy against Vehicle plus compression therapy for proportion of subjects with complete wound closure over the 16-week treatment period from baseline.

Outcome measures

Measure	HP802-247 n=69 Participants HP802-247 (fibrinogen solution \& thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 solution) containing 0.5 x 106 cells per mL every 14 days.	Vehicle n=70 Participants Vehicle Control(fibrinogen solution \& thrombin solution without cells)
Wound Closure	17 participants	23 participants

SECONDARY outcome

Timeframe: 16 Weeks

Compare the efficacy of HP802-247 plus compression therapy against Vehicle plus compression therapy in achieving complete wound closure, based on time in days to closure over the 16-week treatment period from baseline.

Outcome measures

Measure	HP802-247 n=69 Participants HP802-247 (fibrinogen solution \& thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 solution) containing 0.5 x 106 cells per mL every 14 days.	Vehicle n=70 Participants Vehicle Control(fibrinogen solution \& thrombin solution without cells)
Time in Days to Closure	83.4 Days Standard Deviation 33.8	87.1 Days Standard Deviation 42.5

Adverse Events

HP802-247

Serious events: 7 serious events

Other events: 23 other events

Deaths: 0 deaths

Vehicle

Serious events: 7 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Measure	HP802-247 n=77 participants at risk HP802-247 (fibrinogen solution \& thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 solution) containing 0.5 x 106 cells per mL every 14 days.	Vehicle n=78 participants at risk Vehicle Control(fibrinogen solution \& thrombin solution without cells) Vehicle
Cardiac disorders Myocardial infarction	0.00% 0/77 • Treatment emergent Adverse Events (AE) were collected weekly during the 16-week treatment period; post treatment AE were collected during the follow up period. Adverse events were reported at each study visit over the duration of the study	1.3% 1/78 • Number of events 1 • Treatment emergent Adverse Events (AE) were collected weekly during the 16-week treatment period; post treatment AE were collected during the follow up period. Adverse events were reported at each study visit over the duration of the study
Infections and infestations Cellulitis	2.6% 2/77 • Number of events 2 • Treatment emergent Adverse Events (AE) were collected weekly during the 16-week treatment period; post treatment AE were collected during the follow up period. Adverse events were reported at each study visit over the duration of the study	1.3% 1/78 • Number of events 1 • Treatment emergent Adverse Events (AE) were collected weekly during the 16-week treatment period; post treatment AE were collected during the follow up period. Adverse events were reported at each study visit over the duration of the study
Infections and infestations Infected skin ulcer	0.00% 0/77 • Treatment emergent Adverse Events (AE) were collected weekly during the 16-week treatment period; post treatment AE were collected during the follow up period. Adverse events were reported at each study visit over the duration of the study	1.3% 1/78 • Number of events 1 • Treatment emergent Adverse Events (AE) were collected weekly during the 16-week treatment period; post treatment AE were collected during the follow up period. Adverse events were reported at each study visit over the duration of the study
Infections and infestations Pneumonia	0.00% 0/77 • Treatment emergent Adverse Events (AE) were collected weekly during the 16-week treatment period; post treatment AE were collected during the follow up period. Adverse events were reported at each study visit over the duration of the study	1.3% 1/78 • Number of events 1 • Treatment emergent Adverse Events (AE) were collected weekly during the 16-week treatment period; post treatment AE were collected during the follow up period. Adverse events were reported at each study visit over the duration of the study
Infections and infestations Sepsis	1.3% 1/77 • Number of events 1 • Treatment emergent Adverse Events (AE) were collected weekly during the 16-week treatment period; post treatment AE were collected during the follow up period. Adverse events were reported at each study visit over the duration of the study	0.00% 0/78 • Treatment emergent Adverse Events (AE) were collected weekly during the 16-week treatment period; post treatment AE were collected during the follow up period. Adverse events were reported at each study visit over the duration of the study
Infections and infestations Skin infection	1.3% 1/77 • Number of events 1 • Treatment emergent Adverse Events (AE) were collected weekly during the 16-week treatment period; post treatment AE were collected during the follow up period. Adverse events were reported at each study visit over the duration of the study	0.00% 0/78 • Treatment emergent Adverse Events (AE) were collected weekly during the 16-week treatment period; post treatment AE were collected during the follow up period. Adverse events were reported at each study visit over the duration of the study
Infections and infestations Urinary tract infection	0.00% 0/77 • Treatment emergent Adverse Events (AE) were collected weekly during the 16-week treatment period; post treatment AE were collected during the follow up period. Adverse events were reported at each study visit over the duration of the study	1.3% 1/78 • Number of events 1 • Treatment emergent Adverse Events (AE) were collected weekly during the 16-week treatment period; post treatment AE were collected during the follow up period. Adverse events were reported at each study visit over the duration of the study
Injury, poisoning and procedural complications Fall	1.3% 1/77 • Number of events 1 • Treatment emergent Adverse Events (AE) were collected weekly during the 16-week treatment period; post treatment AE were collected during the follow up period. Adverse events were reported at each study visit over the duration of the study	0.00% 0/78 • Treatment emergent Adverse Events (AE) were collected weekly during the 16-week treatment period; post treatment AE were collected during the follow up period. Adverse events were reported at each study visit over the duration of the study
Injury, poisoning and procedural complications Rib fracture	1.3% 1/77 • Number of events 1 • Treatment emergent Adverse Events (AE) were collected weekly during the 16-week treatment period; post treatment AE were collected during the follow up period. Adverse events were reported at each study visit over the duration of the study	0.00% 0/78 • Treatment emergent Adverse Events (AE) were collected weekly during the 16-week treatment period; post treatment AE were collected during the follow up period. Adverse events were reported at each study visit over the duration of the study
Nervous system disorders Cerebrovascular accident	0.00% 0/77 • Treatment emergent Adverse Events (AE) were collected weekly during the 16-week treatment period; post treatment AE were collected during the follow up period. Adverse events were reported at each study visit over the duration of the study	1.3% 1/78 • Number of events 1 • Treatment emergent Adverse Events (AE) were collected weekly during the 16-week treatment period; post treatment AE were collected during the follow up period. Adverse events were reported at each study visit over the duration of the study
Nervous system disorders Encephalopathy	1.3% 1/77 • Number of events 1 • Treatment emergent Adverse Events (AE) were collected weekly during the 16-week treatment period; post treatment AE were collected during the follow up period. Adverse events were reported at each study visit over the duration of the study	0.00% 0/78 • Treatment emergent Adverse Events (AE) were collected weekly during the 16-week treatment period; post treatment AE were collected during the follow up period. Adverse events were reported at each study visit over the duration of the study
Renal and urinary disorders Renal failure acute	1.3% 1/77 • Number of events 1 • Treatment emergent Adverse Events (AE) were collected weekly during the 16-week treatment period; post treatment AE were collected during the follow up period. Adverse events were reported at each study visit over the duration of the study	0.00% 0/78 • Treatment emergent Adverse Events (AE) were collected weekly during the 16-week treatment period; post treatment AE were collected during the follow up period. Adverse events were reported at each study visit over the duration of the study
Renal and urinary disorders Urinary retention	1.3% 1/77 • Number of events 1 • Treatment emergent Adverse Events (AE) were collected weekly during the 16-week treatment period; post treatment AE were collected during the follow up period. Adverse events were reported at each study visit over the duration of the study	0.00% 0/78 • Treatment emergent Adverse Events (AE) were collected weekly during the 16-week treatment period; post treatment AE were collected during the follow up period. Adverse events were reported at each study visit over the duration of the study
Respiratory, thoracic and mediastinal disorders Pulmonary embo;ism	0.00% 0/77 • Treatment emergent Adverse Events (AE) were collected weekly during the 16-week treatment period; post treatment AE were collected during the follow up period. Adverse events were reported at each study visit over the duration of the study	1.3% 1/78 • Number of events 1 • Treatment emergent Adverse Events (AE) were collected weekly during the 16-week treatment period; post treatment AE were collected during the follow up period. Adverse events were reported at each study visit over the duration of the study
Vascular disorders Peripheral ischemia	1.3% 1/77 • Number of events 1 • Treatment emergent Adverse Events (AE) were collected weekly during the 16-week treatment period; post treatment AE were collected during the follow up period. Adverse events were reported at each study visit over the duration of the study	0.00% 0/78 • Treatment emergent Adverse Events (AE) were collected weekly during the 16-week treatment period; post treatment AE were collected during the follow up period. Adverse events were reported at each study visit over the duration of the study

Other adverse events

Measure	HP802-247 n=77 participants at risk HP802-247 (fibrinogen solution \& thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 solution) containing 0.5 x 106 cells per mL every 14 days.	Vehicle n=78 participants at risk Vehicle Control(fibrinogen solution \& thrombin solution without cells) Vehicle
Infections and infestations Cellulitis	10.4% 8/77 • Number of events 9 • Treatment emergent Adverse Events (AE) were collected weekly during the 16-week treatment period; post treatment AE were collected during the follow up period. Adverse events were reported at each study visit over the duration of the study	6.4% 5/78 • Number of events 6 • Treatment emergent Adverse Events (AE) were collected weekly during the 16-week treatment period; post treatment AE were collected during the follow up period. Adverse events were reported at each study visit over the duration of the study
Infections and infestations Infected skin ulcer	2.6% 2/77 • Number of events 2 • Treatment emergent Adverse Events (AE) were collected weekly during the 16-week treatment period; post treatment AE were collected during the follow up period. Adverse events were reported at each study visit over the duration of the study	3.8% 3/78 • Number of events 3 • Treatment emergent Adverse Events (AE) were collected weekly during the 16-week treatment period; post treatment AE were collected during the follow up period. Adverse events were reported at each study visit over the duration of the study
Infections and infestations Wound infecton	3.9% 3/77 • Number of events 5 • Treatment emergent Adverse Events (AE) were collected weekly during the 16-week treatment period; post treatment AE were collected during the follow up period. Adverse events were reported at each study visit over the duration of the study	1.3% 1/78 • Number of events 1 • Treatment emergent Adverse Events (AE) were collected weekly during the 16-week treatment period; post treatment AE were collected during the follow up period. Adverse events were reported at each study visit over the duration of the study
Injury, poisoning and procedural complications Wound complication	5.2% 4/77 • Number of events 5 • Treatment emergent Adverse Events (AE) were collected weekly during the 16-week treatment period; post treatment AE were collected during the follow up period. Adverse events were reported at each study visit over the duration of the study	5.1% 4/78 • Number of events 4 • Treatment emergent Adverse Events (AE) were collected weekly during the 16-week treatment period; post treatment AE were collected during the follow up period. Adverse events were reported at each study visit over the duration of the study
Musculoskeletal and connective tissue disorders Muscle spasms	3.9% 3/77 • Number of events 3 • Treatment emergent Adverse Events (AE) were collected weekly during the 16-week treatment period; post treatment AE were collected during the follow up period. Adverse events were reported at each study visit over the duration of the study	0.00% 0/78 • Treatment emergent Adverse Events (AE) were collected weekly during the 16-week treatment period; post treatment AE were collected during the follow up period. Adverse events were reported at each study visit over the duration of the study
Musculoskeletal and connective tissue disorders Pain in extremity	3.9% 3/77 • Number of events 4 • Treatment emergent Adverse Events (AE) were collected weekly during the 16-week treatment period; post treatment AE were collected during the follow up period. Adverse events were reported at each study visit over the duration of the study	1.3% 1/78 • Number of events 1 • Treatment emergent Adverse Events (AE) were collected weekly during the 16-week treatment period; post treatment AE were collected during the follow up period. Adverse events were reported at each study visit over the duration of the study
Skin and subcutaneous tissue disorders Skin ulcer	14.3% 11/77 • Number of events 17 • Treatment emergent Adverse Events (AE) were collected weekly during the 16-week treatment period; post treatment AE were collected during the follow up period. Adverse events were reported at each study visit over the duration of the study	10.3% 8/78 • Number of events 13 • Treatment emergent Adverse Events (AE) were collected weekly during the 16-week treatment period; post treatment AE were collected during the follow up period. Adverse events were reported at each study visit over the duration of the study

Additional Information

Dr Innes Cargill

Smith and Nephew

Phone: 817-302-3913

Email: innes.cargill@smith-nephew.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60