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

Hepatitis C Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00420784
• Other study ID #: VX06-950-106
• Status: Completed
• Phase: Phase 2
• First received: January 8, 2007
• Last updated: July 9, 2014
• Start date: February 2007
• Est. completion date: April 2009

Study information

• Verified date: July 2014
• Source: Vertex Pharmaceuticals Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationGermany: Federal Institute for Drugs and Medical DevicesCanada: Health CanadaNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 465
• Est. completion date: April 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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)

Study Design

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C

Intervention

Drug:
• Telaprevir
tablet
• Ribavirin
tablet
• Pegylated Interferon Alfa 2a
Solution for injection
• Matching Placebo
Tablet

Locations

Country	Name	City	State
Canada	University of Calgary Medical Clinic - Health Science Centre	Calgary	Alberta
Canada	Toronto Western Hospital	Toronto	Ontario
Canada	BC Hepatitis Program	Vancouver	British Columbia
Germany	Universitatsmedizin Berlin	Berlin
Germany	University Clinic Frankfurt, Department of Internal Medicine	Frankfurt
Netherlands	Academic Medical Center	Amsterdam
Netherlands	Leiden University Medical Center	Leiden
Netherlands	Erasmus MC University Medical Center	Rotterdam
United States	Johns Hopkins University	Baltimore	Maryland
United States	Gulf Coast Research, LLC	Baton Rouge	Louisiana
United States	Birmingham Gastroenterology Associates	Birmingham	Alabama
United States	Beth Isreal Deaconess Medical Center	Boston	Massachusetts
United States	University Internal Medicine Associates, Inc.	Cincinnati	Ohio
United States	Cleveland Clinic	Cleveland	Ohio
United States	Columbia Gastroenterology Associates, PA	Columbia	South Carolina
United States	Liver Institute at Methodist Dallas	Dallas	Texas
United States	University of Colorado Health Sciences Center	Denver	Colorado
United States	Henry Ford Hospital	Detroit	Michigan
United States	Metropolitan Research	Fairfax	Virginia
United States	University of Florida	Gainesville	Florida
United States	Memphis Gastroenterology Group	Germantown	Tennessee
United States	Advanced Liver Therapies	Houston	Texas
United States	Borland-Groover Clinic	Jacksonville	Florida
United States	Mayo Clinic Jacksonville	Jacksonville	Florida
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	USC	Los Angeles	California
United States	North Shore University Hospital	Manhasset	New York
United States	Virology Treatment Center, Maine Medical Center	Portland	Maine
United States	Alamo Medical Research	San Antonio	Texas
United States	Kaiser Permanente Hepatology Research	San Diego	California
United States	University of California, San Diego	San Diego	California
United States	University of California San Francisco	San Francisco	California
United States	University Hepatitis Center at Bach & Godofsky	Sarasota	Florida
United States	Saint Louis University	St Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Vertex Pharmaceuticals Incorporated

Countries where clinical trial is conducted

United States,  Canada,  Germany,  Netherlands,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Subjects With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 24 After the Completion of Study Drug Dosing	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).	24 weeks after the completion of study drug dosing (up to Week 72)	No
Secondary	Percentage of Subjects With Undetectable Plasma HCV RNA at Completion of Study Drug Dosing	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).	Completion of study drug dosing (up to Week 48)	No
Secondary	Percentage of Subjects With Undetectable Plasma HCV RNA	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).	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)	No
Secondary	Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)	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.	Baseline up to 2 weeks after last dose of study drug (up to Week 50)	Yes
Secondary	Number of Subjects With Viral Relapse	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).	After last dose of study drug up to 24 week antiviral follow-up (up to Week 72)	No
Secondary	Maximum (Cmax), Minimum (Cmin) and Average (Cavg) Plasma Concentration of Telaprevir	Only subjects who received telaprevir were to be analyzed for this outcome. Maximum, minimum and average plasma concentrations observed during assessment period were reported.	Week 2, 4, 8, 12, 16, 24	No