Clinical Trial: A Phase 2 Exploratory Pharmacodynamic Study of HP802-247 in Venous Leg Ulcers

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Phase 2 Exploratory Pharmacodynamic Study of HP802-247 in Venous Leg Ulcers

Brief Summary: Assess the influence of HP802-247 on biochemical and cellular markers of inflammation in chronic venous leg ulcers

Detailed Summary:
Sponsor: Healthpoint

Current Primary Outcome: Determine Change From Baseline in Cell Numbers in Subjects With VLU Following the First Dose of HP802-247 [ Time Frame: Wound fluid samples were to be collected one week after the initial dose of HP802-247. ]

The following mediators were to be measured for the chronic ulcer stage: IL-1β, IL-6, TNF-α, IFN, MMP-2, and MMP-9, and the following for the resolving ulcer stage: PGE-2, Lipoxin, GM-CSF, TGFβ, IL-10, LL-37, Indoleamine 2,3-Dioxygenase (IDO), and Arginase (ARG-1). Each of the soluble mediators were to be plotted versus measurement time point [i.e., (pre-study run-in visit (RV)1), baseline (RV3), study visit (SV)2, and SV3]) and by subjects' quartile of percent reduction (%) in target wound area at SV3 from baseline (RV3).


Original Primary Outcome:

  • Determine Change From Baseline in Cell Numbers in Subjects With VLU Following the First Dose of HP802-247 [ Time Frame: 5 weeks ]
  • = Determine change from baseline in cell types in subjects with VLU following the first dose of HP802-247 [ Time Frame: 5 weeks ]
  • = Determine change from baseline in biochemical markers of inflammation in subjects with VLU following the first dose of HP802-247 [ Time Frame: 5 weeks ]


Current Secondary Outcome:

Original Secondary Outcome: Wound closure, defined as complete re-epithelization with no drainage or need for a dressing, will be recorded as a secondary outcome measure following up to 12 weeks of dosing [ Time Frame: 12 weeks ]

Information By: Healthpoint

Dates:
Date Received: May 28, 2014
Date Started: July 2014
Date Completion:
Last Updated: September 19, 2016
Last Verified: September 2016