A Phase 3 interventional study of Daclatasvir and Asunaprevir in Hepatitis C, sponsored by Bristol-Myers Squibb. Completed at 49 sites in 4 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
To demonstrate the effectiveness of DCV 3DAA fixed dose combination with or without Ribavirin in treatment naive cirrhotic subjects.
Masking is Double blind for RBV: two or more parties are unaware of the intervention assignment.
2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.
This study's enrollment of 202 is above the median of 100 across 1,886 interventional studies indexed under Hepatitis A.
Browse Hepatitis A studies →Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.
Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.
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Inclusion Criteria:
Exclusion Criteria:
Triple fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg, BMS-791325 75 mg) tablet orally twice a day for 12 weeks Placebo matching Ribavirin 0mg tablet orally twice a day for 12 weeks
Drug: Daclatasvir · Drug: Asunaprevir · Drug: BMS-791325 · Drug: Placebo matching Ribavirin
Triple fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg, BMS-791325 75 mg) tablet orally twice a day for 12 weeks Ribavirin 200mg tablet orally twice a day for 12 weeks
Drug: Daclatasvir · Drug: Asunaprevir · Drug: BMS-791325 · Drug: Ribavirin
Triple fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg, BMS-791325 75 mg) tablet orally twice a day for 12 weeks Placebo matching Ribavirin 0 mg tablet orally twice a day for 12 weeks
Drug: Daclatasvir · Drug: Asunaprevir · Drug: BMS-791325 · Drug: Placebo matching Ribavirin
Triple fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg, BMS-791325 75 mg) tablet orally twice a day for 12 weeks Ribavirin 200 mg tablet orally twice a day for 12 weeks, Weight based dosing: If \< 75 kg, 1000 mg per day (two 200 mg tablets in AM and three 200 mg tablets in PM); if ≥ 75 kg, 1200 mg per day (three 200 mg tablets in AM and three 200 mg tablets in PM), AM=in the morning, PM=in the evening
Drug: Daclatasvir · Drug: Asunaprevir · Drug: BMS-791325 · Drug: Ribavirin
Also known as: BMS-790052
Also known as: BMS-650032
Also known as: Ribasphere®
Proportion of treated subjects in each of the naive arms with sustained virologic response (SVR12)
SVR12 is defined as Hepatitis C virus ribonucleic acid (HCV RNA) \< Limit of Quantification (LOQ) target detected or target not detected (LOQ TD/TND)
Time frame: Post treatment 12 week
Proportion of treated subjects in each of the experienced arms with SVR12
Time frame: Post treatment 12 Week
Proportion of subjects in each arm who achieve HCV RNA < LOQ TD/TND
Time frame: Weeks: 1, 2, 4, 6, 8, and 12; Post treatment Weeks 4 (SVR4), 8 (SVR8) and 24 (SVR24)
Proportion of subjects in each arm who achieve HCV RNA < LOQ TND
Time frame: Weeks: 1, 2, 4, 6, 8, and 12; Post treatment Weeks 4 (SVR4), 8 (SVR8), 12 (SVR12) and 24 (SVR24)
Safety as measured by frequency of Serious Adverse Events(SAEs)and discontinuations due to Adverse Events(AEs)
Time frame: Up to end of treatment (week 12) + 7 days
Proportion of subjects with anemia defined as Hg < 10 g/dL on-treatment and Hg ≥ 10 g/dL at baseline in each arm within each cohort
Time frame: Up to end of treatment (week 12) + 7 days
Differences in rates of selected Grade 3 - 4 laboratory test result abnormalities
Time frame: Up to end of treatment (week 12) + 7 days
Proportion of subjects achieving SVR12 associated with HCV geno subtype 1a vs 1b
Time frame: Post treatment 12 Week
Proportion of subjects in each arm achieving SVR12 associated with IL28B rs12979860 single nucleotide polymorphism(SNP) status (CC genotype or non-CC genotype)
Time frame: Post treatment 12 Week
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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Bristol-Myers Squibb