Phase 2
Completed N=453
A Study of Telaprevir (VX-950), Pegasys and Copegus in Hepatitis C (PROVE3)
Source: ClinicalTrials.gov NCT00420784 ↗Enrolled (actual)
453
Serious AEs
8.2%
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 — 51.3; 53.1; 24.3; 14.0 percentage of participants — p=<0.001
Summary
The PROVE3 trial is a partially double blinded, randomized, Phase 2 research study of an investigational drug, Telaprevir (VX-950) or Placebo, with Pegylated Interferon Alfa 2a (Peg-IFN-alfa-2a, Pegasys®), and Ribavirin (RBV, Copegus®) in people with genotype 1 hepatitis C who have not achieved a Sustained Viral Response (SVR) with a previous treatment of interferon therapy.
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 |
51.3; 53.1; 24.3; 14.0 | <0.001 sig |
| SECONDARY Percentage of Subjects With Undetectable Plasma HCV RNA at Completion of Study Drug Dosing |
75.7; 67.3; 54.1; 29.8 | — |
| SECONDARY Percentage of Subjects With Undetectable Plasma HCV RNA |
48.7; 44.2; 22.5; 14.0 | <0.001 sig |
| SECONDARY Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs) |
112; 113; 105; 111; 6; 16 | — |
| SECONDARY Number of Subjects With Viral Relapse |
26; 10; 32; 18 | — |
| SECONDARY Maximum (Cmax), Minimum (Cmin) and Average (Cavg) Plasma Concentration of Telaprevir |
2755; 2335; 2610 | — |
Eligibility Criteria
Inclusion Criteria
- Males and females between 18 and 70 years old
- Detectable plasma hepatitis C virus (HCV) ribonucleic acid (RNA) greater than or equal to (>=) 10,000 international units per milliliter (IU/mL)
- Must have chronic hepatitis C (genotype 1) and have already received at least one prior course of pegylated interferon alfa 2a with ribavirin
- Cannot also be infected with Human Immunodeficiency Virus or hepatitis B
- Must be judged to be in general good health and able to receive Pegasys® and Copegus®
- No drug or alcohol abuse in the last year
- Must agree to use two effective methods of birth control during the study and for 6 months after you stop taking study medication. One of the methods needs to be a 'barrier' method (condom or diaphragm)
- If you are a woman, you cannot be in this study if you are pregnant or nursing
Exclusion Criteria
- Participation in any clinical trial of a HCV protease inhibitor of any duration
- Prior response to therapy and failure to achieve SVR which was due to treatment non-compliance
- 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
- History of or current evidence of decompensated liver disease
- Participation in any clinical trial of an investigational drug 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 (NCT00420784). 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.