|
|
![]() |
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
|||||||||||||||||||||||||||||||||||||||||||||
| Sponsored by: |
Vertex Pharmaceuticals Incorporated |
| Information provided by: | Vertex Pharmaceuticals Incorporated |
| ClinicalTrials.gov Identifier: | NCT00420784 |
Purpose
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 |
| MedlinePlus related topics: | Hepatitis Hepatitis C |
| ChemIDplus related topics: | Ribavirin Peginterferon Alfa-2a Interferon alfa-n1 Interferon alfa-2a Interferon alfa-2b Interferons Telaprevir |
| 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 |
| Estimated Study Completion Date: | May 2009 |
| Estimated Primary Completion Date: | May 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
|
Eligibility
| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations![]() |
Show 53 Study Locations |
| Vertex Pharmaceuticals Incorporated |
| Study Director: | Medical Monitor | Vertex Pharmaceuticals Incorporated |
More Information
| Responsible Party: | Vertex Pharmaceuticals Incorporated ( Robert Kauffman M.D., Ph.D. ) |
| Study ID Numbers: | VX06-950-106 |
| First Received: | January 8, 2007 |
| Last Updated: | January 16, 2008 |
| ClinicalTrials.gov Identifier: | NCT00420784 |
| 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) |
|
|
|
|
|