A Study of Telaprevir (VX-950), Pegasys and Copegus in Hepatitis C (PROVE3)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier:
NCT00420784
First received: January 8, 2007
Last updated: July 9, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Hepatitis C
Drug: Telaprevir
Drug: Ribavirin
Drug: Pegylated Interferon Alfa 2a
Drug: Matching Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Vertex Pharmaceuticals Incorporated:

Primary Outcome Measures:
  • Percentage of Subjects With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 24 After the Completion of Study Drug Dosing [ Time Frame: 24 weeks after the completion of study drug dosing (up to Week 72) ] [ Designated as safety issue: No ]
    The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).


Secondary Outcome Measures:
  • Percentage of Subjects With Undetectable Plasma HCV RNA at Completion of Study Drug Dosing [ Time Frame: Completion of study drug dosing (up to Week 48) ] [ Designated as safety issue: No ]
    The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).

  • Percentage of Subjects With Undetectable Plasma HCV RNA [ Time Frame: Up to Week 96 (24 weeks after last dose of study drug for PBO group; 48 weeks after last dose of study drug for telaprevir groups) ] [ Designated as safety issue: No ]
    Percentage of subjects with undetectable HCV RNA at 24 weeks after last dose of study drug for treatment group "PBO 24 Week+Peg-IFN-alfa-2a, RBV 48 Week" and at 48 weeks after last dose of study drug for treatment groups "Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week", "Telaprevir 24 Week+Peg-IFN-alfa-2a,RBV 48 Week" and "Telaprevir 24 Week+Peg-IFN-alfa-2a 24 Week" were presented. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).

  • Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline up to 2 weeks after last dose of study drug (up to Week 50) ] [ Designated as safety issue: Yes ]
    AE: any adverse change from the subject's baseline (pre-treatment) condition, including any adverse experience, abnormal recording or clinical laboratory assessment value which occurs during the course of the study, whether it is considered related to the study drug or not. An adverse event includes any newly occurring event or previous condition that has increased in severity or frequency since the administration of study drug. SAE: medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. "Study drug" includes all investigational agents (including placebo, if applicable) administered during the course of the study.

  • Number of Subjects With Viral Relapse [ Time Frame: After last dose of study drug up to 24 week antiviral follow-up (up to Week 72) ] [ Designated as safety issue: No ]
    Viral relapse was defined as having detectable HCV RNA during antiviral follow-up. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).

  • Maximum (Cmax), Minimum (Cmin) and Average (Cavg) Plasma Concentration of Telaprevir [ Time Frame: Week 2, 4, 8, 12, 16, 24 ] [ Designated as safety issue: No ]
    Only subjects who received telaprevir were to be analyzed for this outcome. Maximum, minimum and average plasma concentrations observed during assessment period were reported.


Enrollment: 465
Study Start Date: February 2007
Study Completion Date: April 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week
Single loading dose of telaprevir 1125 milligram (mg) tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 24 weeks.
Drug: Telaprevir
tablet
Other Name: VX-950
Drug: Ribavirin
tablet
Other Name: RBV
Drug: Pegylated Interferon Alfa 2a
Solution for injection
Other Name: Peg-IFN-alfa-2a
Experimental: Telaprevir 24 Week+Peg-IFN-alfa-2a,RBV 48 Week
Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
Drug: Telaprevir
tablet
Other Name: VX-950
Drug: Ribavirin
tablet
Other Name: RBV
Drug: Pegylated Interferon Alfa 2a
Solution for injection
Other Name: Peg-IFN-alfa-2a
Experimental: Telaprevir 24 Week+Peg-IFN-alfa-2a 24 Week
Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 24 weeks.
Drug: Telaprevir
tablet
Other Name: VX-950
Drug: Pegylated Interferon Alfa 2a
Solution for injection
Other Name: Peg-IFN-alfa-2a
Placebo Comparator: PBO 24 Week+Peg-IFN-alfa-2a, RBV 48 Week
Placebo (PBO) matched to telaprevir tablet orally thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
Drug: Ribavirin
tablet
Other Name: RBV
Drug: Pegylated Interferon Alfa 2a
Solution for injection
Other Name: Peg-IFN-alfa-2a
Drug: Matching Placebo
Tablet

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00420784

  Show 53 Study Locations
Sponsors and Collaborators
Vertex Pharmaceuticals Incorporated
Investigators
Study Director: Medical Monitor Vertex Pharmaceuticals Incorporated
  More Information

No publications provided by Vertex Pharmaceuticals Incorporated

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier: NCT00420784     History of Changes
Other Study ID Numbers: VX06-950-106
Study First Received: January 8, 2007
Results First Received: June 22, 2011
Last Updated: July 9, 2014
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)

Keywords provided by Vertex Pharmaceuticals Incorporated:
Genotype 1

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Interferon-alpha
Interferons
Peginterferon alfa-2a
Ribavirin
Anti-Infective Agents
Antimetabolites
Antineoplastic Agents
Antiviral Agents
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014