Trial Outcomes & Findings for A Phase 2 Exploratory Pharmacodynamic Study of HP802-247 in Venous Leg Ulcers (NCT NCT02154087)
NCT ID: NCT02154087
Last Updated: 2016-10-03
Results Overview
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).
TERMINATED
PHASE2
1 participants
Wound fluid samples were to be collected one week after the initial dose of HP802-247.
2016-10-03
Participant Flow
Subjects were enrolled at a single US investigation site, between July 14,2014 and November 2, 2014.
Subjects entered a 2-week run-in; subjects whose wound radius decreased by \< 0.349 cm/2weeks and met all other inclusion/exclusion (I/E) criteria were eligible for randomization. HP802-247
Participant milestones
| Measure |
HP802-247
HP802-247: 260 µL (130 µL, one spray, of each component) containing 0.5 x 10.6 cells per mL, alternating weekly with Vehicle
HP802-247 (fibrinogen solution \& thrombin solution containing living, irradiated, growth-arrested keratinocytes and fibroblasts) applied every 2 weeks, with Vehicle (fibrinogen solution \& acellular thrombin solution) on alternate weeks, for up to 12 weeks, or until wound closure occurred, which ever came first
|
|---|---|
|
Overall Study
STARTED
|
1
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
HP802-247
HP802-247: 260 µL (130 µL, one spray, of each component) containing 0.5 x 10.6 cells per mL, alternating weekly with Vehicle
HP802-247 (fibrinogen solution \& thrombin solution containing living, irradiated, growth-arrested keratinocytes and fibroblasts) applied every 2 weeks, with Vehicle (fibrinogen solution \& acellular thrombin solution) on alternate weeks, for up to 12 weeks, or until wound closure occurred, which ever came first
|
|---|---|
|
Overall Study
Study Termination
|
1
|
Baseline Characteristics
A Phase 2 Exploratory Pharmacodynamic Study of HP802-247 in Venous Leg Ulcers
Baseline characteristics by cohort
| Measure |
HP802-247
n=1 Participants
HP802-247: 260 µL (130 µL, one spray, of each component) containing 0.5 x 10.6 cells per mL, alternating weekly with Vehicle
HP802-247 (fibrinogen solution \& thrombin solution containing living, irradiated, growth-arrested keratinocytes and fibroblasts) applied every 2 weeks, with Vehicle (fibrinogen solution \& acellular thrombin solution) on alternate weeks, for up to 12 weeks, or until wound closure occurred, which ever came first
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Wound fluid samples were to be collected one week after the initial dose of HP802-247.Population: Due to the failure of HP802-247-09-029 to show superiority over its vehicle in study 802-247-09-029, this study was terminated after enrollment of one of the proposed 25 subjects. No data was collected.
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).
Outcome measures
Outcome data not reported
Adverse Events
HP802-247
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60