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NCT01656889 · ClinicalTrials.gov registry record · Phase 3
Study Investigating the Safety and Efficacy of HP802-247 in the Treatment of Venous Leg Ulcers
A Phase 3 study, sponsored by Healthpoint.
- Completed
- Registry status
- Phase 3
- Development phase
- 447
- Enrollment target
NCT01656889: Completed Phase 3 study, sponsored by Healthpoint.
NCT01656889 is a Phase 3 study that has completed, run by Healthpoint. The registered enrollment target is 447 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (42% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01656889, a Phase 3 study, has completed, sponsored by Healthpoint.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 447 participants
- Enrollment target
Study Summary
This study is being done to find out if an investigational product called HP802-247 can help people with venous leg ulcers. Investigational means that HP802-247 has not been approved by the U.S. Food and Drug Administration (FDA). This research is being done to compare the efficacy of HP802-247 plus compression therapy against Vehicle plus compression therapy in achieving complete wound closure over the 12-week treatment period. Vehicle looks the same as HP802-247 but contains no cells.
Primary Outcome
For each treatment group the area of each subject's target ulcer was measured on a weekly basis, for up to 12 weeks, using a laser-based wound imaging system in conjunction with software to measure area. Following initial closure subjects returned for four weekly visits to confirm wound closure. Wounds that remained closed for four weeks were classified as confirmed closures; if a wound opened at any of the 4 visits it was not considered to have closed. For subjects who dropped from the study, t
Interventions
- BIOLOGICAL Vehicle
- BIOLOGICAL HP-802-247
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 447 participants |
| Start Date | 2012-08 |
| Est. Completion | 2014-12 |
| Phase | Phase 3 |
What the finished NCT01656889 record still lists
NCT01656889 is an interventional study that assigns participants to a tested intervention. The registered 447 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (42% lower).
The record links to 0 conditions, and to 2 interventions - of which Vehicle is the first listed.
NCT01656889 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01656889 about?
NCT01656889 is a clinical study titled "Study Investigating the Safety and Efficacy of HP802-247 in the Treatment of Venous Leg Ulcers". This study is being done to find out if an investigational product called HP802-247 can help people with venous leg ulcers. Investigational means that HP802-247 has not been approved by the U.S. Food and Drug Administration (FDA). This research is being done to compare the efficacy of HP802-247 plu...
What is the current status of trial NCT01656889?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 447 participants. The study started on 2012-08. Estimated completion is 2014-12.
What interventions are being tested in trial NCT01656889?
The interventions under investigation include: Vehicle (BIOLOGICAL), HP-802-247 (BIOLOGICAL).
Who is sponsoring clinical trial NCT01656889?
This trial is sponsored by Healthpoint, which has 25 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01656889's enrollment target sits among peer trials
447 864th of 2000 higher than 1,137 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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