Phase 3
N=159
Phase III China GT 1b Interferon (IFN) Intolerant Prev Exclude Dual
Hepatitis C
Bottom Line
View on ClinicalTrials.gov: NCT01995266 ↗Enrolled (actual)
159
Serious AEs
3.1%
Results posted
Jul 2019
Primary outcome: Primary: Percentage of Participants With Sustained Virologic Response (SVR) at Post-Treatment Follow-up Week 24 (SVR24) — 91.2 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Asunaprevir (Drug); Daclatasvir (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bristol-Myers Squibb
- Primary completion
- Jul 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response (SVR) at Post-Treatment Follow-up Week 24 (SVR24) |
91.2 | — |
| SECONDARY Percentage of Participants With Sustained Virologic Response (SVR) at Post-Treatment Follow-up Week 12 (SVR12) |
91.2 | — |
| SECONDARY Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Death, and AEs Leading to Discontinuation |
1; 5; 118; 2 | — |
| SECONDARY Percentage of Participants With SVR24 by the rs12979860 Single Nucleotide Polymorphisms (SNP) in the IL 28B Gene at Post-Treatment Follow-up Week 24 |
89.5; 93.0; 100 | — |
| SECONDARY Percentage of Participants With HCV RNA< LLOQ Target Not Detected at the End of Treatment (Week 24) |
92.5 | — |
| SECONDARY Number of Participants With Rapid Virologic Response (RVR) |
136 | — |
| SECONDARY Percentage of Participants With Complete Early Virologic Response (cEVR) |
96.2 | — |
| SECONDARY Number of Participants With Extended Rapid Virologic Response (eRVR) |
134 | — |
| SECONDARY Number of Participants With HCV RNA < LLOQ Target Detected or Not Detected at the End of Treatment (Week 24) |
149 | — |
| SECONDARY Number of Participants With Virologic Response (VR) at Treatment Week 4 and 12 |
151 | — |
Summary
Patients with chronic hepatitis genotype 1b, who are intolerant or ineligible to Interferon alfa therapy with or without Ribavirin, will be treated for 24 weeks with Daclatasvir (DCV) Dual regimen (= Daclatasvir + Asunaprevir) and followed for an additional 24 weeks post-treatment in order to determine the safety and efficacy of the DCV DUAL regimen
Eligibility Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria
- Males and females, ≥ 18 years of age
- Subjects chronically infected with HCV Genotype (GT)-1b only as documented by positive HCV RNA and anti-HCV antibody at screening and either:
- Positive anti-HCV antibody, HCV RNA or positive HCV genotype test at least 6 months prior to screening
or
- Liver biopsy consistent with chronic HCV infection (evidence of fibrosis and/or inflammation)
- Subjects who are intolerant to previous therapy with Interferon Alfa (IFNα) either with or without Ribavirin (RBV) (I±R)(independent of previous response to therapy) or ineligible for I±R and who meet one of the criteria below:
- Anemia: the I±R intolerants are subjects who were previously treated with IFNα/RBV therapy and had a decline in hemoglobin to 100 ng/mL OR ≥ 50 and ≤ 100 ng/mL requires a liver ultrasound and subjects with findings suspicious of hepatocellular carcinoma (HCC) are excluded
- Confirmed hemoglobin < 8.5 g/dL
- Confirmed ANC < 0.5 x 10(9) cells/L
- Confirmed platelet count < 50,000 cells/mm3
Data sourced from ClinicalTrials.gov (NCT01995266). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.