Phase 2
Completed N=323
Phase 2 Study of VX-950, Pegasys® With and Without Copegus® in Hepatitis C
Chronic Hepatitis C
Source: ClinicalTrials.gov NCT00372385 ↗
Enrolled (actual)
323
Serious AEs
13.6%
Results posted
Jul 2011
Primary outcomePrimary: Percentage of Subjects With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 24 After the Completion of Study Drug Dosing — 46.3; 69.1; 59.8; 35.9 percentage of participants — p=0.0026
Summary
Compare the effectiveness of telaprevir (VX-950) in combination with Pegylated Interferon Alfa 2a (Peg-IFN-alfa-2a) with and without Ribavirin (RBV) in reducing plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 24 After the Completion of Study Drug Dosing |
46.3; 69.1; 59.8; 35.9 | 0.0026 sig |
| SECONDARY Percentage of Subjects With Undetectable Plasma HCV RNA at Week 12 After the Completion of Study Drug Dosing |
47.6; 69.1; 59.8; 37.2 | 0.0041 sig |
| SECONDARY Percentage of Subjects With Undetectable Plasma HCV RNA at Completion of Study Drug Dosing |
54.9; 70.4; 80.5; 61.5 | — |
| SECONDARY Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs) |
81; 80; 82; 78; 8; 16 | — |
| SECONDARY Number of Subjects With Viral Relapse |
10; 8; 19; 22 | — |
| SECONDARY Maximum (Cmax), Minimum (Cmin) and Average (Cavg) Plasma Concentration of Telaprevir |
3370; 2510; 3055 | — |
Eligibility Criteria
Inclusion Criteria
- Hepatitis C virus Genotype 1 with detectable plasma hepatitis C virus RNA
- Have been infected with Hepatitis C virus for greater than (>) 6 months
- Seronegative for hepatitis B surface antigen and human immunodeficiency virus 1 and 2
- Must agree to use 2 methods of contraception, including 1 barrier method, during and for 24 weeks after the completion of the study (unless the subject is a female of documented non-child-bearing potential)
- Female subjects must have a negative pregnancy test at all visits before the first dose.
Exclusion Criteria
- Received any approved or investigational drug or drug regimen for the treatment of hepatitis C.
- Any medical contraindications to Peg-IFN-alfa-2a or Ribavirin therapy
- Any other cause of significant liver disease in addition to hepatitis C; this may include but is not limited to, hepatitis B, drug or alcohol-related cirrhosis, autoimmune hepatitis, hemochromatosis, Wilson's disease, Nonalcoholic Steatohepatitis or primary biliary cirrhosis.
- Diagnosed or suspected hepatocellular carcinoma.
- Histologic evidence of hepatic cirrhosis (including compensated cirrhosis) based on a liver biopsy taken within 2 years before Study start.
- Alcohol/drug abuse or excessive use in the last 12 months.
- Participation in any investigational drug study within 90 days before drug administration or participation in more than 2 drug studies in the last 12 months (exclusive of the current study).
Data sourced from ClinicalTrials.gov (NCT00372385). 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.