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

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ClinicalTrials.gov Identifier: NCT01737762
Recruitment Status : Completed
First Posted : November 30, 2012
Results First Posted : July 26, 2017
Last Update Posted : July 26, 2017
Sponsor:
Information provided by (Responsible Party):
Healthpoint

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Venous Leg Ulcers
Interventions Biological: HP802-247
Biological: Vehicle
Enrollment 155

Recruitment Details 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.
Pre-assignment Details 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.
Arm/Group Title HP802-247 Vehicle
Hide Arm/Group Description 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 Control(fibrinogen solution & thrombin solution without cells)
Period Title: Overall Study
Started 77 78
Completed 57 61
Not Completed 20 17
Reason Not Completed
Adverse Event             2             2
Lost to Follow-up             1             0
Withdrawal by Subject             2             2
Progressive disease             1             2
Physician Decision             1             1
Moved from area             2             1
Trial termination             11             9
Arm/Group Title HP802-247 Vehicle Total
Hide Arm/Group Description 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 Control(fibrinogen solution & thrombin solution without cells) Total of all reporting groups
Overall Number of Baseline Participants 69 70 139
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 69 participants 70 participants 139 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
37
  53.6%
44
  62.9%
81
  58.3%
>=65 years
32
  46.4%
26
  37.1%
58
  41.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 69 participants 70 participants 139 participants
62.4  (15.1) 61.0  (12.1) 61.7  (13.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 69 participants 70 participants 139 participants
Female
28
  40.6%
32
  45.7%
60
  43.2%
Male
41
  59.4%
38
  54.3%
79
  56.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 69 participants 70 participants 139 participants
Hispanic or Latino
17
  24.6%
15
  21.4%
32
  23.0%
Not Hispanic or Latino
52
  75.4%
55
  78.6%
107
  77.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 69 participants 70 participants 139 participants
American Indian or Alaska Native
2
   2.9%
1
   1.4%
3
   2.2%
Asian
1
   1.4%
0
   0.0%
1
   0.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
13
  18.8%
11
  15.7%
24
  17.3%
White
51
  73.9%
58
  82.9%
109
  78.4%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
2
   2.9%
0
   0.0%
2
   1.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 69 participants 70 participants 139 participants
Canada 4 3 7
United States 65 67 132
1.Primary Outcome
Title Wound Closure
Hide Description 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.
Time Frame 16 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HP802-247 Vehicle
Hide Arm/Group Description:
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 Control(fibrinogen solution & thrombin solution without cells)
Overall Number of Participants Analyzed 69 70
Measure Type: Number
Unit of Measure: participants
17 23
2.Secondary Outcome
Title Time in Days to Closure
Hide Description 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.
Time Frame 16 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HP802-247 Vehicle
Hide Arm/Group Description:
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 Control(fibrinogen solution & thrombin solution without cells)
Overall Number of Participants Analyzed 69 70
Mean (Standard Deviation)
Unit of Measure: Days
83.4  (33.8) 87.1  (42.5)
Time Frame 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 Event Reporting Description Adverse events were reported at each study visit over the duration of the study
 
Arm/Group Title HP802-247 Vehicle
Hide Arm/Group Description 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 Control(fibrinogen solution & thrombin solution without cells)

Vehicle

All-Cause Mortality
HP802-247 Vehicle
Affected / at Risk (%) Affected / at Risk (%)
Total   0/77 (0.00%)      0/78 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
HP802-247 Vehicle
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/77 (9.09%)      7/78 (8.97%)    
Cardiac disorders     
Myocardial infarction  1  0/77 (0.00%)  0 1/78 (1.28%)  1
Infections and infestations     
Cellulitis  1  2/77 (2.60%)  2 1/78 (1.28%)  1
Infected skin ulcer  1  0/77 (0.00%)  0 1/78 (1.28%)  1
Pneumonia  1  0/77 (0.00%)  0 1/78 (1.28%)  1
Sepsis  1  1/77 (1.30%)  1 0/78 (0.00%)  0
Skin infection  1  1/77 (1.30%)  1 0/78 (0.00%)  0
Urinary tract infection  1  0/77 (0.00%)  0 1/78 (1.28%)  1
Injury, poisoning and procedural complications     
Fall  1  1/77 (1.30%)  1 0/78 (0.00%)  0
Rib fracture  1  1/77 (1.30%)  1 0/78 (0.00%)  0
Nervous system disorders     
Cerebrovascular accident  1  0/77 (0.00%)  0 1/78 (1.28%)  1
Encephalopathy  1  1/77 (1.30%)  1 0/78 (0.00%)  0
Renal and urinary disorders     
Renal failure acute  1  1/77 (1.30%)  1 0/78 (0.00%)  0
Urinary retention  1  1/77 (1.30%)  1 0/78 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Pulmonary embo;ism  1  0/77 (0.00%)  0 1/78 (1.28%)  1
Vascular disorders     
Peripheral ischemia  1  1/77 (1.30%)  1 0/78 (0.00%)  0
1
Term from vocabulary, MedDRA 13.1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
HP802-247 Vehicle
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   23/77 (29.87%)      19/78 (24.36%)    
Infections and infestations     
Cellulitis  1  8/77 (10.39%)  9 5/78 (6.41%)  6
Infected skin ulcer  1  2/77 (2.60%)  2 3/78 (3.85%)  3
Wound infecton  1  3/77 (3.90%)  5 1/78 (1.28%)  1
Injury, poisoning and procedural complications     
Wound complication  1  4/77 (5.19%)  5 4/78 (5.13%)  4
Musculoskeletal and connective tissue disorders     
Muscle spasms  1  3/77 (3.90%)  3 0/78 (0.00%)  0
Pain in extremity  1  3/77 (3.90%)  4 1/78 (1.28%)  1
Skin and subcutaneous tissue disorders     
Skin ulcer  1  11/77 (14.29%)  17 8/78 (10.26%)  13
1
Term from vocabulary, MedDRA 13.1
Indicates events were collected by systematic assessment
The trial was terminated due to the failure of the Phase 3 study
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr Innes Cargill
Organization: Smith and Nephew
Phone: 817-302-3913
Responsible Party: Healthpoint
ClinicalTrials.gov Identifier: NCT01737762     History of Changes
Other Study ID Numbers: 802-247-09-031
First Submitted: November 20, 2012
First Posted: November 30, 2012
Results First Submitted: June 27, 2017
Results First Posted: July 26, 2017
Last Update Posted: July 26, 2017