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A Study of the Efficacy and Safety of ABH001 in the Treatment of Patients With Epidermolysis Bullosa Who Have Wounds That Are Not Healing

NCT01749306 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2013-11-21

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy and safety of ABH001 in the treatment of patients with epidermolysis bullosa who have wounds that are not healing.

It is hypothesized that ABH001 may initiate and continue wound healing in patients with epidermolysis bullosa.

Conditions

  • Epidermolysis Bullosa

Interventions

BIOLOGICAL

ABH001

ABH001 applications topically every 4 weeks (±1 week) with protocol-specified dressings until wound healed or up to 44 weeks

OTHER

Control wound treatment

Control wound care with protocol-specified dressings every 4 weeks (±1 week) up to 20 weeks with optional cross-over to ABH001 for additional 20 weeks

Sponsors & Collaborators

  • Shire Regenerative Medicine, Inc.

    lead INDUSTRY

Principal Investigators

  • Alan Arbuckle, MD, FAAD, FAAP · H&E Enterprises

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2013-11-30
Completion
2013-11-30

Countries

  • United States
  • Austria
  • Canada
  • France
  • Germany
  • Poland
  • Portugal
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01749306 on ClinicalTrials.gov