Dose Finding Study of HP802-247 in Venous Leg Ulcers

H

Healthpoint

Status and phase

Completed
Phase 2

Conditions

Venous Leg Ulcer
Venous Stasis Ulcers

Treatments

Biological: Placebo (Vehicle)
Biological: HP802-247

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

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)

Trial contacts and locations

30

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Data sourced from clinicaltrials.gov

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