CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 228 enrolled
Drug / intervention
HP802-247 +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00852995
NCT00852995Phase 2Completed
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A Phase II Randomized, Double Blind, Placebo Controlled Dose Finding Study Investigating the Efficacy of HP802-247 in Venous Leg Ulcers

Healthpoint·interventional·Posted Feb 27, 2009·Updated Oct 24, 2016

In Brief

A Phase 2 clinical trial evaluating HP802-247 and Placebo (Vehicle) for Venous Leg Ulcer and Venous Stasis Ulcers. Completed, enrolled 228 participants across 30 sites in 2 countries.

Detailed Summary

This is a 16-week study for subjects with a venous leg ulcer between the knee and ankle. This research is being done to determine the effectiveness of two dosing frequencies and two different concentrations of HP802-247, together with standard care, compared to placebo, plus standard care.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVenous Leg Ulcer, Venous Stasis Ulcers
CountriesCanada, United States
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 27, 2009
Enrollment StartFeb 1, 2009
Primary CompletionApr 1, 2011
Study CompletionJul 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 17.3 years ago

Interventions

HP802-247biological

One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.

Placebo (Vehicle)biological

Placebo (Vehicle) consisting of: Component 1 - acellular fibrinogen solution; Component 2 - acellular thrombin solution