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Sponsored by: |
Vertex Pharmaceuticals Incorporated |
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Information provided by: | Vertex Pharmaceuticals Incorporated |
ClinicalTrials.gov Identifier: | NCT00420784 |
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.
Condition | Intervention | Phase |
---|---|---|
Hepatitis C |
Drug: Telaprevir Drug: Ribavirin Drug: Peg-interferon Alfa-2a |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 440 |
Study Start Date: | January 2007 |
Study Completion Date: | April 2009 |
Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Placebo Comparator
Placebo + Peg-IFN + RBV for 24 weeks followed by Peg-IFN + RBV for 24 weeks
|
Drug: Ribavirin
tablet
Drug: Peg-interferon Alfa-2a
Solution for injection
|
2: Experimental
Telaprevir + Peg-IFN + RBV for 24 weeks followed by Peg-IFN + RBV for 24 weeks
|
Drug: Telaprevir
tablet
Drug: Ribavirin
tablet
Drug: Peg-interferon Alfa-2a
Solution for injection
|
3: Experimental
Telaprevir + Peg-IFN for 24 weeks
|
Drug: Telaprevir
tablet
Drug: Peg-interferon Alfa-2a
Solution for injection
|
4: Experimental
Telaprevir + Peg-IFN + RBV for 12 weeks followed by Placebo + Peg-IFN + RBV for 12 weeks
|
Drug: Telaprevir
tablet
Drug: Ribavirin
tablet
Drug: Peg-interferon Alfa-2a
Solution for injection
|
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Medical Monitor | Vertex Pharmaceuticals Incorporated |
Responsible Party: | Vertex Pharmaceuticals Incorporated ( Robert Kauffman M.D., Ph.D. ) |
Study ID Numbers: | VX06-950-106 |
Study First Received: | January 8, 2007 |
Last Updated: | May 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00420784 History of Changes |
Health Authority: | United States: Food and Drug Administration; Germany: Federal Institute for Drugs and Medical Devices; Canada: Health Canada; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Genotype 1 |
Antimetabolites Interferon-alpha Anti-Infective Agents Liver Diseases Immunologic Factors Ribavirin Interferons Hepatitis, Viral, Human |
Angiogenesis Inhibitors Antiviral Agents Hepatitis Virus Diseases Digestive System Diseases Peginterferon alfa-2a Hepatitis C Interferon Alfa-2a |
Antimetabolites Anti-Infective Agents Liver Diseases Molecular Mechanisms of Pharmacological Action Flaviviridae Infections Immunologic Factors Antineoplastic Agents Ribavirin Physiological Effects of Drugs Hepatitis, Viral, Human Therapeutic Uses Hepatitis C Angiogenesis Modulating Agents |
Growth Inhibitors Interferon-alpha RNA Virus Infections Growth Substances Interferons Antiviral Agents Angiogenesis Inhibitors Pharmacologic Actions Virus Diseases Hepatitis Digestive System Diseases Peginterferon alfa-2a Interferon Alfa-2a |