Phase 2
Completed N=250
Phase 2 Study of VX-950, Pegasys®, and Copegus® in Hepatitis C
Chronic Hepatitis C
Source: ClinicalTrials.gov NCT00336479 ↗
Enrolled (actual)
250
Serious AEs
8.8%
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 — 41.3; 67.1; 60.8; 35.3 percentage of participants — p=0.0014
Summary
Study the effectiveness of telaprevir (VX-950) in combination with Pegylated Interferon Alfa 2a (Peg-IFN-alfa-2a) and 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 |
41.3; 67.1; 60.8; 35.3 | 0.0014 sig |
| SECONDARY Percentage of Subjects With Undetectable Plasma HCV RNA at Week 12 After the Completion of Study Drug Dosing |
36.0; 58.2; 53.2; 35.3 | 0.0051 sig |
| SECONDARY Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs) |
75; 79; 79; 17; 4; 5 | — |
| SECONDARY Number of Subjects With Viral Relapse |
8; 3; 1; 3 | — |
| SECONDARY Maximum (Cmax), Minimum (Cmin) and Average (Cavg) Plasma Concentration of Telaprevir |
3032.48; 2235.51; 2738.46 | — |
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 Pegylated Interferon 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 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 (NCT00336479). 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.