Phase 2
Completed N=211
Study to Determine the Safety and Effectiveness of Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) in Patients Who Have Previously Not Received the Standard of Care
Chronic Hepatitis C
Source: ClinicalTrials.gov NCT01359644 ↗
Enrolled (actual)
211
Serious AEs
7.1%
Results posted
Oct 2015
Primary outcomePrimary: Percentage of Participants With Sustained Virologic Response at Post Treatment Week 12 (SVR12) — 96.4; 85.7; 95.0; 100.0 Percentage of participants
Summary
The purpose of the study is to determine whether therapy with the combination of PSI-7977 and daclatasvir (BMS-790052) with or without ribavirin is effective in treating hepatitis C virus (HCV) infection when given for 12 or 24 weeks as measured by sustained virologic response with undetectable HCV RNA 12 weeks post treatment
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response at Post Treatment Week 12 (SVR12) |
96.4; 85.7; 95.0; 100.0; 93.3; 100.0 | — |
| SECONDARY Percentage of Participants With Sustained Virologic Response at Post Treatment Week 24 (SVR24) |
94.6; 92.9; 100.0; 95.7; 93.3; 100.0 | — |
| SECONDARY Percentage of Participants With Viral Breakthrough During the Treatment Period |
0; 0; 0; 0; 3.3; 0 | — |
| SECONDARY Percentage of Participants Who Experienced Viral Relapse During Follow-up Period |
0; 0; 0; 1.4; 3.3; 0 | — |
| SECONDARY Change From Baseline in log10 Hepatitis C Virus (HCV) RNA at Follow-up Week 24 |
1.28; 0.95; 0.95; 0.98; 0.95; 0.95 | — |
| SECONDARY Number of Participants Who Died and With Serious Adverse Events (SAEs) and Grade 3-4 Adverse Events (AEs), During the Treatment Period Prior to Addition of Rescue Therapy |
0; 0; 0; 0; 1; 6 | — |
| SECONDARY Number of Participants Who Died and With Serious Adverse Events (SAEs), Grade 3-4 Adverse Events (AEs), and Grade 3-4 Abnormalities on Laboratory Test Results During Follow-up Period |
0; 0; 0; 0; 2; 4 | — |
Eligibility Criteria
Inclusion Criteria
- Men and women, ages 18 to 70 years.
- Participants infected with hepatitis C virus (HCV) genotype 1, 2, or 3, with no previous exposure to an interferon formulation (ie, interferon-alpha, pegylated interferon-alpha) ribavirin, or other HCV-specific direct-acting antiviral (including daclatasvir and PSI-7977).
- Patients should have chronic hepatitis C genotype 1a, 1b, 2, or 3 as documented by: positive test results for anti-HCV antibody; HCV RNA; or a HCV genotype at least 6 months prior to screening, and HCV RNA and anti-HCV antibody at the time of screening.
Exclusion Criteria
- Evidence of a medical condition associate with chronic liver disease other than HCV.
- History of variceal bleeding, hepatic encephalopathy, or ascites requiring management with diuretics or paracentesis.
- History of hemophilia.
- History of torsade de pointes.
- Current or known history of cancer (except in situ carcinoma of the cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to enrollment.
- History of gastrointestinal disease or surgical procedure (except cholecystectomy).
- History of clinically significant cardiac disease.
- Blood transfusion within 4 weeks prior to study drug administration.
- Poor venous access.
- Any other medical, psychiatric, and/or social reason which, in the opinion of the Investigator, would make the candidate inappropriate for participation in this study.
Data sourced from ClinicalTrials.gov (NCT01359644). 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.