NCT01749306

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

A Multicenter, Prospective, Randomized, Open-label, Intra-subject Controlled Study of the Efficacy and Safety of ABH001 for the Treatment of Stalled Chronic Cutaneous Wounds Associated With Generalized Epidermolysis Bullosa

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Shire Regenerative Medicine, Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2012-12-01
• Primary completion: 2013-11-01
• Completion: 2013-11-01
• First posted: 2012-12-13
• Last updated: 2013-11-21

Locations

14 sites across 8 countries: United States, Austria, Canada, France, Germany, Poland, Portugal, Spain