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

Stopped early · Phase 2

Conditions studied: Duchenne Muscular Dystrophy

In brief

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).

Key facts

Study ID: NCT02525302
Run by: Akashi Therapeutics
People needed: 10
Starts: 2015-05-01
Expected to finish: 2016-12-30
Last updated by the study team: 2019-03-12

Who can join

Age: 6 and older, up to 20. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

Completed both previous studies HALO-DMD-01 and HALO-DMD-02
Ability to provide written informed consent
Ability to understand and follow site and protocol instruction for the entire duration of the study

You may not qualify if…

Answering yes to any of the following make the subject NOT eligible to participate in the study.
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
History of severe allergic or anaphylactic reactions
Recent report of drug/alcohol abuse

Where it is running

University of California, Davis Medical Center — Sacramento, California, United States
Kennedy Krieger Institute, Johns Hopkins School of Medicine — Baltimore, Maryland, United States
Washington University School of Medicine — St Louis, Missouri, United States
Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
Nationwide Children's Hospital — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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