Phase 3
N=447
Study Investigating the Safety and Efficacy of HP802-247 in the Treatment of Venous Leg Ulcers
Venous Leg Ulcers
Bottom Line
View on ClinicalTrials.gov: NCT01656889 ↗Enrolled (actual)
447
Serious AEs
8.5%
Results posted
Mar 2016
Primary outcome: Primary: Compare the Treatment Groups for the Proportion of Subjects With Complete Wound Closure Over the 12-Week Treatment Period From Baseline — 129; 126; 82; 84 participants — p=0.5896
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- HP-802-247 (Biological); Vehicle (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Healthpoint
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Compare the Treatment Groups for the Proportion of Subjects With Complete Wound Closure Over the 12-Week Treatment Period From Baseline |
129; 126; 82; 84 | 0.5896 |
| 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. |
57.0; 50.0 | .3675 |
| SECONDARY Compare the Treatment Groups for the Percentage of Closed Ulcers at Each Visit of the 12-Week Treatment Period From Baseline |
0; 0; 2.4; 1.9; 5.7; 9.5 | 0.6426 |
| SECONDARY Number of Subjects With Durable Wound Healing Over the 3 Months Following Complete Wound Closure |
120; 114; 14; 18; 118; 112 | — |
| SECONDARY Change in Pain Associated With the Target Leg at Each of the 12 Double Blind Treatment Weeks |
-3.74; -2.19; -4.18; -4.03; -6.14; -5.91 | 0.3601 |
| SECONDARY Change in Target Ulcer Pain |
-5.08; -5.05; -7.59; -6.95; -10.32; -9.58 | 0.9853 |
| 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. |
57.0; 50.0 | < 0.05 sig |
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.
Eligibility Criteria
Inclusion Criteria
- Provide informed consent.
- Age ≥ 18 years and of either sex.
- Willing to comply with protocol instructions, including allowing all study assessments.
- Have a venous leg ulcer (VLU) between the knee and ankle (at or above the malleolus), with a surface area ≥ 2.0 cm2 and ≤ 12.0 cm2
- Venous insufficiency confirmed by duplex Doppler ultrasound examination for valvular or venous incompetence.
- Arterial supply adequacy confirmed
- Target ulcer involves a full thickness skin loss, but WITHOUT exposure of tendon, muscle, or bone.
- Target ulcer duration ≥ 6 weeks but ≤ 104 weeks (24 months).
- Acceptable state of health and nutrition
Exclusion Criteria
- History of anaphylaxis, serum sickness, or erythema multiforme reaction to aprotinin, bovine serum albumin or bovine serum proteins, penicillin, streptomycin, amphotericin B.
- Prior diagnosis of Systemic Lupus Erythematosus with elevated anti-DNA antibody titers, Buerger's disease (thromboangiitis obliterans), current diagnosis of vasculitis, or current diagnosis of claudication.
- Therapy with another investigational agent within thirty (30) days of Screening, or during the study.
- A target ulcer of non-venous etiologies (e.g., sickle cell anemia, necrobiosis lipoidica diabeticorum, pyoderma gangrenosum, vasculopathic or vasculitic).
- Documented history of osteomyelitis at the target wound location within 6 months preceding the Screening Visit.
- Refusal of or inability to tolerate compression therapy.
- Therapy of the target ulcer with autologous skin graft, Apligraf™, or Dermagraft™ within 30 days preceding the Screening Visit.
- History of cancer in the preceding 5 years (other than carcinoma in situ of the cervix or adequately treated non-melanoma skin cancers).
- Any prior exposure to HP802-247 or its vehicle.
Data sourced from ClinicalTrials.gov (NCT01656889). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.