A Phase 3 interventional study of Asunaprevir and Daclatasvir in Hepatitis C Virus, sponsored by Bristol-Myers Squibb. Completed at 79 sites in 15 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-10-09.
Sponsored by Bristol-Myers Squibb · Phase 3, Interventional, and Treatment
The purpose of this study is to assess efficacy, as determined by the proportion of subjects with Sustained Virologic Response at Post-Treatment Week 12 (SVR12), defined as Hepatitis C virus (HCV) Ribonucleic acid (RNA) \< Limit of quantitation (LOQ) at post-treatment Week 12.
2,356 studies on the registry are indexed under Hepatitis C; 101 are open to participants now.
This study's enrollment of 398 is above the median of 79 across 1,660 interventional studies indexed under Hepatitis C.
Browse Hepatitis C studies →Bristol-Myers Squibb is the lead sponsor of 1,562 studies on the registry; 118 are open to participants now.
Of its 435 completed or terminated interventional studies of FDA-regulated products, 227 (52%) have results posted.
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Exclusion Criteria:
Asunaprevir: Capsule, Oral, 100 mg, Twice daily, 24 weeks Daclatasvir: Tablet, Oral, 60 mg, Once daily, 24 weeks Peg-interferon Alfa-2a: Injection, subcutaneous (SC), 180 mcg/0.5 mL, Once weekly, 24 weeks Ribavirin: Tablet, Oral, 1000 mg/1200 mg (total daily dose), 24 weeks
Drug: Asunaprevir · Drug: Daclatasvir · Drug: Peg-interferon Alfa-2a · Drug: Ribavirin
Also known as: BMS-650032
Also known as: BMS-790052
Also known as: Pegasys®
Also known as: Copegus®
Proportion of genotype 1 subjects with SVR12, defined as HCV RNA < LOQ at post-treatment Week 12, for all subjects infected with HCV genotype 1
Time frame: At 12 weeks post-treatment
On-treatment safety, as measured by frequency of Serious Adverse Events (SAEs) and discontinuations due to Adverse Events (AEs) through the end of treatment
Time frame: Through the end of treatment (maximum up to 24 weeks) plus 7 days
Proportion of subjects with SVR12 (HCV RNA < LOQ at post-treatment Week 12) by the rs12979860 single nucleotide polymorphisms (SNP) in the IL28 gene
Time frame: At post-treatment Week 12
Proportion of subjects with HCV RNA undetectable
Time frame: Weeks 1, 2, 4, 6, 8 and 12; at both Weeks 4 and 12 [Extended rapid virologic response (eRVR)], end of treatment (up to 24 weeks), post-treatment Week 12 or post-treatment Week 24
Proportion of subjects with HCV RNA < LOQ
Time frame: Weeks 1, 2, 4, 6, 8 and 12; at both Weeks 4 and 12, end of treatment (up to 24 weeks), post-treatment Week 24 (SVR24)
Proportion of patients with SVR12 (HCV RNA < LOQ at post-treatment Week 12) for HCV genotype 4 subjects
Time frame: Post-treatment Week 12
This study is completed, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Asunaprevir · Daclatasvir · Peginterferon alfa-2a · Ribavirin