Dose Finding Study of HP802-247 in Venous Leg Ulcers

Healthpoint

Status and phase: Completed; Phase 2

Conditions: Venous Leg Ulcer; Venous Stasis Ulcers

Treatments: Biological: HP802-247; Biological: Placebo (Vehicle)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00852995

802-247-09-015

Details and patient eligibility

About

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.

Enrollment: 228 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Provide informed consent.
• Willing to comply with protocol instructions, including allowing all study assessments.
• Have a venous leg ulcer (venous etiology)between the knee and ankle, at or above the malleolus.
• Venous insufficiency confirmed by duplex Doppler ultrasound examination for valvular or venous incompetence.
• Target ulcer duration greater than or equal to 6 weeks but less than or equal to 24 months.

Exclusion criteria

• Women who are pregnant or lactating
• Therapy with another investigational agent within thirty (30) days of Screening, or during the study.
• A target ulcer of non-venous etiologies.
• Refusal of or inability to tolerate compression therapy.
• Therapy of the target ulcer with tissue-engineered cell-based skin equivalents within 30 days preceding the Screening Visit.
• Therapy of the target ulcer with topical growth factors within 1 week preceding the Screening Visit.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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228 participants in 5 patient groups, including a placebo group

A - Low Q7D

Experimental group

Description:

Low dose HP802-247, applied at each visit

Treatment:

Biological: HP802-247

B - Low Q14D

Experimental group

Description:

Low dose HP802-247 applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12

Treatment:

Biological: HP802-247

C - High Q7D

Experimental group

Description:

High dose HP802-247, applied at each visit

Treatment:

Biological: HP802-247

D - High Q14D

Experimental group

Description:

High dose HP802-247, applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12

Treatment:

Biological: HP802-247

E - Vehicle

Placebo Comparator group

Description:

Placebo (Vehicle), applied at each visit

Treatment:

Biological: Placebo (Vehicle)