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Extension Study of ACE-031 in Subjects With Duchenne Muscular Dystrophy

NCT01239758 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2013-02-01

No results posted yet for this study

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. \[Note: This study was terminated based on preliminary safety data. Pending further analysis of safety data and discussion with health authorities, a new ACE-031 trial will be planned.\]

Conditions

Interventions

BIOLOGICAL

ACE-031 (Extension of cohort 1 from core study, A031-03)

ACE-031 0.5 mg/kg subcutaneously once every 4 weeks for 24 weeks.

BIOLOGICAL

ACE-031 (Extension of cohort 2 from core study, A031-03)

Up to 1.0 mg/kg subcutaneously once every 2 weeks for 24 weeks.

BIOLOGICAL

ACE-031 (Extension of cohort 3 from core study, A031-03)

Up to 2.5 mg/kg subcutaneously once every 4 weeks for 24 weeks.

Sponsors & Collaborators

  • Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
4 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2011-05-31
Completion
2011-05-31

Countries

  • Canada

Study Locations

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Entities

Diseases

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 NCT01239758 on ClinicalTrials.gov