At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 19 enrolled
Drug / intervention
AVI-4658 for Injectiondrug
Likely dose
AVI-4658 for Injection 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Clinical Study to Assess the Safety fo AVI-4658 in Subjects With Duchenne Muscular Dystrophy Due to a Frame-shift Mutation Amenable to Correction by Skipping Exon 51.
In Brief
A Phase 2 clinical trial evaluating AVI-4658 for Injection for Duchenne Muscular Dystrophy. Completed, enrolled 19 participants across 2 sites.
Detailed Summary
The specific aim of this Phase I/II study is to assess the safety of intravenous administered Morpholino oligomer directed against exon 51 (AVI-4658 PMO).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDuchenne Muscular Dystrophy
CountriesUnited Kingdom
CollaboratorsBritish Medical Research Council
Timeline
Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJan 2009
First PostedFeb 2009
Primary CompletionJun 2010
Study CompletionDec 2010
TodayJul 2026
First PostedFeb 16, 2009
Enrollment StartJan 1, 2009
Primary CompletionJun 1, 2010
Study CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 17.4 years ago
Interventions
AVI-4658 for Injectiondrug
AVI-4658 for Injection, is packaged as 100 mg/mL in phosphate buffered saline with 1 mL per vial. Study dosages will be infused over a 1 hour period with Normal saline in 6 dose cohorts.