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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01616524
Other study ID # AI452-017
Secondary ID 2011-004885-14
Status Completed
Phase Phase 3
First received June 7, 2012
Last updated September 23, 2015
Start date July 2012
Est. completion date September 2014
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Clinical Trial Summary

The purpose of this study is to determine if 24 weeks of treatment with Pegylated Interferon Lambda plus Ribavirin and 12 weeks of treatment with Pegylated Interferon Lambda plus Ribavirin and Daclatasvir will be safe and effective for treatment of hepatitis C compared to 24 weeks of treatment with Pegylated Interferon Alfa-2a plus Ribavirin


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Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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Sponsors (1)

Lead Sponsor Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Chile,  Finland,  France,  Greece,  Hong Kong,  Italy,  Japan,  Korea, Republic of,  Mexico,  Netherlands,  New Zealand,  Russian Federation,  Singapore,  Taiwan,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of subjects who achieve Sustained Virologic Response at post-treatment follow-up week 12 (SVR12) Post-treatment follow-up week 12 No
Secondary Proportion of subjects with Rapid virologic response (RVR) [undetectable Hepatitis C virus (HCV) Ribonucleic acid (RNA)] On-treatment Week 4 No
Secondary Proportion of subjects with treatment emergent cytopenic abnormalities (anemia as defined by Hb < 10 g/dL, neutropenia as defined by ANC < 750 mm3 or thrombocytopenia as defined by platelets < 50,000 mm3) Hb = Hemoglobin ANC = Absolute neutrophil count Up to week 12 or week 24 Yes
Secondary Proportion of subjects with on-treatment interferon-associated flu-like symptoms (as defined by pyrexia or chills or pain) Up to week 12 or week 24 Yes
Secondary Proportion of subjects with on-treatment musculoskeletal symptoms (as defined by arthralgia or myalgia or back pain) Up to week 12 or week 24 Yes
Secondary Proportion of subjects with Sustained Virologic Response at post-treatment follow-up week 24 (SVR24) by treatment group Post-treatment week 24 No
Secondary Proportion of subjects with on-treatment Serious adverse events (SAEs) Up to week 12 or week 24 Yes
Secondary Proportion of subjects with dose reductions Up to week 12 or week 24 Yes
Secondary Proportion of subjects who discontinue due to Adverse events (AEs) Up to week 12 or week 24 Yes
Secondary Proportion of subjects with SVR12 in subjects with genotype-3 (GT-3) chronic HCV infection Post-treatment follow-up week 12 No
Secondary Proportion of subjects with on-treatment constitutional symptoms (fatigue or asthenia) Up to week 12 or week 24 Yes
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