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Safety and Efficacy Trial of HP802-247 in the Treatment of Chronic Venous Leg Ulcers

This study has been terminated.
(based on outcome of trial NCT01656889.)
Sponsor:
Information provided by (Responsible Party):
Healthpoint
ClinicalTrials.gov Identifier:
NCT01853384
First received: May 8, 2013
Last updated: September 19, 2016
Last verified: September 2016
Results First Received: September 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
Conditions: Venous Ulcer
Venous Stasis Ulcer
Ulcer
Interventions: Biological: HP802-247
Other: HP802-247 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 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.

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 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.


Participant Flow for 4 periods

Period 1:   Randomized
    HP802-247 Plus Compression Therapy   HP802-247 Vehicle Plus Compression Therapy
STARTED   131   121 
COMPLETED   69   75 
NOT COMPLETED   62   46 
Adverse Event                5                3 
Death                1                2 
Lost to Follow-up                1                1 
Withdrawal by Subject                5                3 
Sponsor Decision                47                34 
Other                3                3 

Period 2:   Enrolled in Follow up Period
    HP802-247 Plus Compression Therapy   HP802-247 Vehicle Plus Compression Therapy
STARTED   96   94 
Not Enrolled in Follow-up   35   27 
COMPLETED   96   94 
NOT COMPLETED   0   0 

Period 3:   Completed Follow up Visit 1
    HP802-247 Plus Compression Therapy   HP802-247 Vehicle Plus Compression Therapy
STARTED   96   94 
COMPLETED   82   85 
NOT COMPLETED   14   9 
Early Termination                13                9 
Withdrawal by Subject                1                0 

Period 4:   Completed Follow up Visit 2
    HP802-247 Plus Compression Therapy   HP802-247 Vehicle Plus Compression Therapy
STARTED   96   94 
COMPLETED   93   91 
NOT COMPLETED   3   3 
Adverse Event                1                0 
Withdrawal by Subject                1                2 
Death                1                0 
Lost to Follow-up                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.
No text entered.

Reporting Groups
  Description
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.

Total Total of all reporting groups

Baseline Measures
   HP802-247 Plus Compression Therapy   HP802-247 Vehicle Plus Compression Therapy   Total 
Overall Participants Analyzed 
[Units: Participants]
 131   121   252 
Age 
[Units: Years]
Mean (Full Range)
 65.6 
 (28 to 90) 
 68.1 
 (28 to 92) 
 66.8 
 (28 to 92) 
Age, Customized 
[Units: Participants]
     
18-39 years   6   3   9 
40-49 years   6   3   9 
50-59 years   26   20   46 
60-69 years   40   40   80 
70+ years   53   55   108 
Gender 
[Units: Participants]
     
Female   76   63   139 
Male   55   58   113 
Ethnicity (NIH/OMB) 
[Units: Participants]
     
Hispanic or Latino   1   0   1 
Not Hispanic or Latino   129   120   249 
Unknown or Not Reported   1   1   2 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   0   0   0 
Asian   0   0   0 
Native Hawaiian or Other Pacific Islander   0   0   0 
Black or African American   0   0   0 
White   131   121   252 
More than one race   0   0   0 
Unknown or Not Reported   0   0   0 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Compare the Treatment Groups for the Number of Subjects With Complete Wound Closure Over the 12-Week Treatment Period From Baseline   [ Time Frame: Weekly, over 12 Weeks or until wound closure, which ever occurred first ]

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 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.   [ Time Frame: 12 weeks ]

4.  Secondary:   Compare the Treatment Groups for the Proportion of Subjects With Wound Closure at Each 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 ]

5.  Secondary:   Number of Subjects With Durable Wound Healing Over the 3 Months Following Complete Wound Closure   [ Time Frame: Target ulcer status observed at two (visit 1) and three (visit 2) months following initial ulcer closure. ]

6.  Secondary:   Change From Baseline in Pain Associated With the Target Wound at Each of the 12 Double Blind Treatment Weeks   [ Time Frame: Baseline and Weekly, over the 12 week treatment period ]

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


  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
No text entered.


  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, Inc
phone: 1-817-302-3914
e-mail: Jaime.Dickerson@smith-nephew.com



Responsible Party: Healthpoint
ClinicalTrials.gov Identifier: NCT01853384     History of Changes
Other Study ID Numbers: 802-247-09-032
2012-003286-18 ( EudraCT Number )
Study First Received: May 8, 2013
Results First Received: September 19, 2016
Last Updated: September 19, 2016
Health Authority: United States: Food and Drug Administration
Belgium: Ethics Committee
Belgium: Federal Agency for Medicinal Products and Health Products
Czech Republic: Ethics Committee
Czech Republic: State Institute for Drug Control
Germany: Ethics Commission
Germany: Paul-Ehrlich-Institut
Hungary: National Institute for Quality and Organizational Development in Healthcare and Medicines
Hungary: Research Ethics Medical Committee
Poland: Ethics Committee
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products