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Generated: February 20, 2019

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CLINICAL TRIALS PROFILE FOR ETEPLIRSEN

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Clinical Trials for Eteplirsen

Trial ID Title Status Sponsor Phase Summary
NCT00844597 Dose-Ranging Study of AVI-4658 to Induce Dystrophin Expression in Selected Duchenne Muscular Dystrophy (DMD) Patients Completed British Medical Research Council Phase 1/Phase 2 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).
NCT00844597 Dose-Ranging Study of AVI-4658 to Induce Dystrophin Expression in Selected Duchenne Muscular Dystrophy (DMD) Patients Completed Sarepta Therapeutics Phase 1/Phase 2 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).
NCT01396239 Efficacy Study of AVI-4658 to Induce Dystrophin Expression in Selected Duchenne Muscular Dystrophy Patients Completed Sarepta Therapeutics Phase 2 This study is designed to assess the efficacy, safety, tolerability, and pharmacokinetics (PK) of AVI-4658 (eteplirsen) in both 50.0 mg/kg and 30.0 mg/kg doses administered over 24 weeks in subjects diagnosed with Duchenne muscular dystrophy (DMD).
NCT01540409 Efficacy, Safety, and Tolerability Rollover Study of Eteplirsen in Subjects With Duchenne Muscular Dystrophy Active, not recruiting Sarepta Therapeutics Phase 2 The primary objective of this study is to assess the ongoing efficacy, safety, and tolerability of an additional 212 weeks of treatment with eteplirsen injection in Duchenne muscular dystrophy (DMD) subjects who have successfully completed the 28 week eteplirsen study: Study 4658-us-201. This study will also evaluate the correlation between biomarkers for DMD and the clinical status of participating DMD subjects.
NCT02255552 Confirmatory Study of Eteplirsen in DMD Patients Recruiting Sarepta Therapeutics Phase 3 The main objective of this study is to provide confirmatory evidence of efficacy of eteplirsen (AVI-4658) in Duchenne muscular dystrophy (DMD) patients that are amenable to skipping exon 51. Additional objectives include evaluation of safety, biomarkers and the long-term effects of eteplirsen up to 96 weeks. Sites are currently being initiated into the study. Initiation of approximately 39 planned sites in the United States is expected to be completed by June 2016. The initiated sites can be found in the "Contacts and Locations" section of this posting in addition to a listing of the city and states of sites the investigators are working to initiate. This information will be updated on a rolling basis as additional sites are initiated.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Eteplirsen

Condition Name

Condition Name for Eteplirsen
Intervention Trials
Duchenne Muscular Dystrophy (DMD) 3
Duchenne Muscular Dystrophy 3
Muscular Dystrophy, Duchenne 1
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Condition MeSH

Condition MeSH for Eteplirsen
Intervention Trials
Muscular Dystrophy, Duchenne 7
Muscular Dystrophies 7
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Clinical Trial Locations for Eteplirsen

Trials by Country

Trials by Country for Eteplirsen
Location Trials
United States 56
United Kingdom 2
Belgium 1
Italy 1
Germany 1
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Trials by US State

Trials by US State for Eteplirsen
Location Trials
Ohio 5
California 4
Missouri 4
Washington 3
Iowa 3
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Clinical Trial Progress for Eteplirsen

Clinical Trial Phase

Clinical Trial Phase for Eteplirsen
Clinical Trial Phase Trials
Phase 3 1
Phase 2 5
Phase 1/Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Eteplirsen
Clinical Trial Phase Trials
Recruiting 3
Active, not recruiting 2
Completed 2
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Clinical Trial Sponsors for Eteplirsen

Sponsor Name

Sponsor Name for Eteplirsen
Sponsor Trials
Sarepta Therapeutics 7
British Medical Research Council 1
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Sponsor Type

Sponsor Type for Eteplirsen
Sponsor Trials
Industry 7
Other 1
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