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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01858272
Other study ID # Limb compression
Secondary ID
Status Completed
Phase Phase 1
First received May 8, 2013
Last updated January 10, 2017
Start date September 2004
Est. completion date June 2009

Study information

Verified date January 2017
Source University of Pennsylvania
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The primary objectives of this study are to evaluate the efficacy, dosing, and safety of an intra-ulcer injection H5.020CMV.PDGF-b in adults who have a venous leg ulcer. The primary endpoint of this Phase I trial is the determination of the Maximum Tolerated Dose (MTD) for the intra-ulcer injection of H5.020CMV.PDGF-b.


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Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Drug:
H5.020CMV.PDGF-b and limb compression bandage


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Pennsylvania

Outcome

Type Measure Description Time frame Safety issue
Primary Maximum tolerated dose. The Maximum tolerated dose(MTD) for this trial will be defined as the highest dose at which zero or one of six subjects demonstrates Dose limiting toxicity (DLT). 28 days after the subject receives the study drug. Yes
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