HT-100 Long-term Study in DMD Patients Who Completed HALO-DMD-02

• Status: Terminated
• Trial end date: 2016-12-30
• Target enrollment: 0
• Participant gender: Male

Summary

This study, HALO-DMD-03, is a follow-on study to HALO-DMD-01 and HALO-DMD-02, and allows continued open-label access to HT-100 for subjects who have completed these studies. HALO-DMD-03 will provide safety and strength and function data on continuous long-term dosing. Data from this study will be used to inform the safety, tolerability, and dose selection for a future trial of HT-100 in boys with Duchenne Muscular Dystrophy (DMD).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Akashi Therapeutics
• Treatments: Halofuginone

Criteria

Inclusion Criteria:

1. Completed both previous studies HALO-DMD-01 and HALO-DMD-02

2. Ability to provide written informed consent

3. Ability to understand and follow site and protocol instruction for the entire duration of the study

Exclusion Criteria:

Answering yes to any of the following make the subject NOT eligible to participate in the study.

1. Clinically significant major disease not related to DMD that would make it not safe to be in the study or affect ability to follow the protocol

2. History of severe allergic or anaphylactic reactions

3. Recent report of drug/alcohol abuse