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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Healthpoint
ClinicalTrials.gov Identifier:
NCT01737762
First received: November 20, 2012
Last updated: June 27, 2017
Last verified: September 2016
Results First Received: June 27, 2017  
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

  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 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
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 solution) containing 0.5 x 106 cells per mL every 14 days.
Vehicle Vehicle Control(fibrinogen solution & thrombin solution without cells)

Participant Flow:   Overall Study
    HP802-247   Vehicle
STARTED   77   78 
COMPLETED   57   61 
NOT COMPLETED   20   17 
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 



  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 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)
Total Total of all reporting groups

Baseline Measures
   HP802-247   Vehicle   Total 
Overall Participants Analyzed 
[Units: Participants]
 69   70   139 
Age 
[Units: Participants]
Count of 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 
[Units: Years]
Mean (Standard Deviation)
 62.4  (15.1)   61.0  (12.1)   61.7  (13.6) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      28  40.6%      32  45.7%      60  43.2% 
Male      41  59.4%      38  54.3%      79  56.8% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of 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) 
[Units: Participants]
Count of 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 
[Units: Participants]
     
Canada   4   3   7 
United States   65   67   132 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Wound Closure   [ Time Frame: 16 Weeks ]

2.  Secondary:   Time in Days to Closure   [ Time Frame: 16 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
The trial was terminated due to the failure of the Phase 3 study


  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: Dr Innes Cargill
Organization: Smith and Nephew
phone: 817-302-3913
e-mail: innes.cargill@smith-nephew.com



Responsible Party: Healthpoint
ClinicalTrials.gov Identifier: NCT01737762     History of Changes
Other Study ID Numbers: 802-247-09-031
Study First Received: November 20, 2012
Results First Received: June 27, 2017
Last Updated: June 27, 2017