drugset / Trial / NCT01239758
Extension Study of ACE-031 in Subjects With Duchenne Muscular Dystrophy
Non-randomizedParallel-groupOpen-labelTreatment
Summary
To evaluate the long-term safety and tolerability of ACE-031 administration in subjects with Duchenne muscular dystrophy (DMD) who participated in Study A031-03. \[Note: This study was terminated based on preliminary safety data. Pending further analysis of safety data and discussion with health authorities, a new ACE-031 trial will be planned.\]
Timeline
- Start
- 2010-10
- Primary completion
- 2011-05
- Completion
- 2011-05
Outcome
Outcome not reported
Stopped: “This study was terminated based on preliminary safety data.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | RAMATERCEPT | Protein / enzyme biologic | 0.5 mg/kg | Subcutaneous |
| Subject | RAMATERCEPT | Protein / enzyme biologic | 1 mg/kg | Subcutaneous |
| Subject | RAMATERCEPT | Protein / enzyme biologic | 2.5 mg/kg | Subcutaneous |