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Study Investigating the Safety and Efficacy of HP802-247 in the Treatment of Venous Leg Ulcers

This study has been completed.
Sponsor:
Collaborator:
Smith & Nephew, Inc.
Information provided by (Responsible Party):
Healthpoint
ClinicalTrials.gov Identifier:
NCT01656889
First received: August 1, 2012
Last updated: February 16, 2016
Last verified: February 2016
Results First Received: January 19, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Venous Leg Ulcers
Interventions: Biological: HP-802-247
Biological: Vehicle

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were screened at 43 sites in the US and 5 in Canada; between August 22, 2012 and April 18, 2014; sites included independent and hospital wound clinics and private practice sites.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
HP802-247

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 106 cells per mL every 14 days.

HP-802-247: 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 106 cells per mL every 14 days.

Vehicle

Vehicle Control (fibrinogen solution & thrombin solution without cells)

Vehicle


Participant Flow for 2 periods

Period 1:   Treatment Period, 12 Weeks
    HP802-247   Vehicle
STARTED   222 [1]   225 [1] 
COMPLETED   210 [2]   214 [2] 
NOT COMPLETED   12   11 
Adverse Event                10                4 
Death                0                1 
Lost to Follow-up                1                1 
Withdrawal by Subject                1                2 
Protocol Violation                0                1 
Moved out of the area                0                2 
[1] Randomized (Met all I/E criteria at completion of run-in)
[2] Completed treatment

Period 2:   Post Treatment Follow-Up, 3 Months
    HP802-247   Vehicle
STARTED   210   213 
COMPLETED   206   204 
NOT COMPLETED   4   9 
Death                1                5 
Lost to Follow-up                1                2 
Withdrawal by Subject                2                1 
Site Closure                0                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT population

Reporting Groups
  Description
HP802-247

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 106 cells per mL every 14 days.

HP-802-247: 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 106 cells per mL every 14 days.

Vehicle

Vehicle Control (fibrinogen solution & thrombin solution without cells)

Vehicle

Total Total of all reporting groups

Baseline Measures
   HP802-247   Vehicle   Total 
Overall Participants Analyzed 
[Units: Participants]
 211   210   421 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   136   138   274 
>=65 years   75   72   147 
Age 
[Units: Years]
Mean (Standard Deviation)
 60.5  (14.8)   61.0  (12.5)   60.7  (13.7) 
Gender 
[Units: Participants]
     
Female   71   82   153 
Male   140   128   268 
Ethnicity (NIH/OMB) 
[Units: Participants]
     
Hispanic or Latino   36   42   78 
Not Hispanic or Latino   175   168   343 
Unknown or Not Reported   0   0   0 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   1   0   1 
Asian   3   1   4 
Native Hawaiian or Other Pacific Islander   1   1   2 
Black or African American   43   34   77 
White   160   167   327 
More than one race   0   0   0 
Unknown or Not Reported   3   7   10 
Region of Enrollment 
[Units: Participants]
     
Canada   9   13   22 
United States   202   197   399 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Compare the Treatment Groups for the Proportion of Subjects With Complete Wound Closure Over the 12-Week Treatment Period From Baseline   [ Time Frame: 12 Weeks ]

2.  Secondary:   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.   [ Time Frame: 12 Weeks ]

3.  Secondary:   Compare the Treatment Groups for the Percentage of Closed Ulcers at Each Visit of the 12-Week Treatment Period From Baseline   [ Time Frame: Weekly, over the 12 week treatment period, or until wound closure, which ever occurred first ]

4.  Secondary:   Number of Subjects With Durable Wound Healing Over the 3 Months Following Complete Wound Closure   [ Time Frame: Target ulcer status observed at two and three months following initial ulcer closure. ]

5.  Secondary:   Change in Pain Associated With the Target Leg at Each of the 12 Double Blind Treatment Weeks   [ Time Frame: Weekly, over the 12 week treatment period, baseline ]

6.  Secondary:   Change in Target Ulcer Pain   [ Time Frame: Weekly, over 12 week treament period, baseline ]

7.  Secondary:   Compare the Efficacy of the Treatment Groups in Achieving Complete Wound Closure, Based on the Median Time (in Days) to Closure Over the 12-Week Treatment Period From Baseline.   [ Time Frame: 12 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Jaime E Dickerson, PhD
Organization: Smith & Nephew
phone: 1-817-302-3914
e-mail: Jaime.Dickerson@smith-nephew.com



Responsible Party: Healthpoint
ClinicalTrials.gov Identifier: NCT01656889     History of Changes
Other Study ID Numbers: 802-247-09-029
Study First Received: August 1, 2012
Results First Received: January 19, 2016
Last Updated: February 16, 2016
Health Authority: United States: Food and Drug Administration