Phase 2
Completed N=395
Study of Daclatasvir (BMS-790052) Add-on to Standard of Care in Treatment- naïve Patients
Source: ClinicalTrials.gov NCT01125189 ↗Enrolled (actual)
395
Serious AEs
7.9%
Results posted
Oct 2015
Primary outcomePrimary: Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With Extended Rapid Virologic Response (eRVR) — 54.4; 54.1; 13.9 percentage of participants
Summary
To establish that at least 1 dose of daclatasvir combined with standard of care (pegylated interferon and ribavirin) is safe and well tolerated and demonstrates extended rapid virologic response rates at least 35% greater than those with placebo.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With Extended Rapid Virologic Response (eRVR) |
54.4; 54.1; 13.9 | — |
| PRIMARY Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With Sustained Virologic Response (SVR24) |
59.2; 59.6; 37.5 | — |
| PRIMARY Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Who Died |
12; 13; 6; 7; 7; 8 | — |
| SECONDARY Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With Rapid Virologic Response (RVR) |
59.9; 56.8; 15.3 | — |
| SECONDARY Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With Complete Early Virologic Response (cEVR) |
77.6; 75.3; 43.1 | — |
| SECONDARY Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With 12-week Sustained Virologic Response (SVR12) |
64.6; 60.3; 36.1 | — |
| SECONDARY Percentage of Resistant Variants Associated With Virologic Failure |
8.2; 10.3; 2.8; 2.0; 2.1; 25.0 | — |
Eligibility Criteria
Inclusion Criteria
- Patients chronically infected with hepatitis C virus (HCV) genotype 1 or 4
- HCV RNA viral load of ≥100, 000 IU/mL
- No previous exposure to interferon, pegIFNα, or RBV
- Results of a liver biopsy demonstrating absence of cirrhosis obtained ≤24 months prior to randomization. Compensated cirrhotics with Hepatitis C virus genotype 1 infection are eligible, but will be capped at 10% of the randomized study population (biopsy can be from any time period prior to randomization)
- Findings on ultrasound, computed tomography scan, or magnetic resonance imaging 12 months prior to randomization that do not demonstrate evidence of hepatocellular carcinoma
- Body mass index of 18 to 35 kg/m^2
Exclusion Criteria
- Positive for hepatitis B or HIV-1/HIV-2 antibody at screening
- Evidence of a medical condition associated with chronic liver disease other than HCV
- Evidence of decompensated cirrhosis based on radiologic criteria or biopsy
Data sourced from ClinicalTrials.gov (NCT01125189). 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. Informational only — not medical advice.