| January 8, 2007 |
| May 8, 2009 |
| January 2007 |
| April 2009 (final data collection date for primary outcome measure) |
| Undetectable HCV RNA [ Time Frame: 24 weeks after the completion of treatment ] [ Designated as safety issue: No ] |
| Undetectable HCV RNA 24 weeks after the completion of treatment. |
| Complete list of historical versions of study NCT00420784 on ClinicalTrials.gov Archive Site |
- Undetectable HCV RNA [ Time Frame: at end of treatment ] [ Designated as safety issue: No ]
- Undetectable HCV RNA [ Time Frame: 48 weeks after completion of treatment (Groups B, C, and D) ] [ Designated as safety issue: No ]
- Adverse events and clinical laboratory assessments, including ALT and other liver function tests. [ Time Frame: throughout study ] [ Designated as safety issue: Yes ]
- Genotypic and phenotypic analyses of the NS3•4A HCV region. [ Time Frame: throughout study ] [ Designated as safety issue: No ]
- Pharmacokinetic assessments of telaprevir, Peg-IFN-a-2a, and RBV. [ Time Frame: throughout study ] [ Designated as safety issue: No ]
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- Undetectable HCV RNA at end of treatment.
- Undetectable HCV RNA 48 weeks after completion of treatment (Groups B, C, and D).
- Adverse events and clinical laboratory assessments, including ALT and other liver function tests.
- Genotypic and phenotypic analyses of the NS3•4A HCV region.
- Pharmacokinetic assessments of telaprevir, Peg-IFN-a-2a, and RBV.
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| |
| A Study of Telaprevir (VX-950), Pegasys and Copegus in Hepatitis C |
| A Phase 2 Study of Telaprevir (VX-950) in Combination With Peginterferon Alfa-2a (Pegasys®), and Ribavirin (Copegus®) in Subjects With Genotype 1 Hepatitis C Who Have Not Achieved Sustained Viral Response With a Prior Course of Interferon Based Therapy |
The PROVE3 trial is a partially double blinded, randomized, Phase 2 research study of an investigational drug, Telaprevir (VX-950) or Placebo, with peginterferon alfa-2a (Pegasys®), and ribavirin (Copegus®) in people with genotype 1 hepatitis C who have not achieved a Sustained Viral Response (SVR) with a previous treatment of interferon therapy. |
| |
| Phase II |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Hepatitis C |
- Drug: Telaprevir
- Drug: Ribavirin
- Drug: Peg-interferon Alfa-2a
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- Placebo Comparator: Placebo + Peg-IFN + RBV for 24 weeks followed by Peg-IFN + RBV for 24 weeks
- Experimental: Telaprevir + Peg-IFN + RBV for 24 weeks followed by Peg-IFN + RBV for 24 weeks
- Experimental: Telaprevir + Peg-IFN for 24 weeks
- Experimental: Telaprevir + Peg-IFN + RBV for 12 weeks followed by Placebo + Peg-IFN + RBV for 12 weeks
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| |
| |
| Completed |
| 440 |
| April 2009 |
| April 2009 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Males and females between 18 and 70 years old
- Detectable plasma HCV RNA > or = 10,000 IU/mL
- Must have chronic hepatitis C (genotype 1) and have already received at least one prior course of peginterferon with ribavirin
- Can not also be infected with HIV (AIDS) 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 can not 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).
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| Both |
| 18 Years to 70 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States, Canada, Germany, Netherlands, Puerto Rico |
| |
| NCT00420784 |
| Robert Kauffman M.D., Ph.D., Vertex Pharmaceuticals Incorporated |
| VX06-950-106 |
| Vertex Pharmaceuticals Incorporated |
|
| Study Director: |
Medical Monitor |
Vertex Pharmaceuticals Incorporated |
|
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| Vertex Pharmaceuticals Incorporated |
| May 2009 |