Phase 2 Study of VX-950, Pegasys®, and Copegus® in Hepatitis C

Chronic Hepatitis C Clinical Trial

Official title:

A Phase 2 Study of VX-950 in Combination With Peginterferon Alfa-2a (Pegasys®), With Ribavirin (Copegus®) in Subjects With Genotype 1 Hepatitis C Who Have Not Received Prior Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00336479
• Other study ID #: VX05-950-104
• Status: Completed
• Phase: Phase 2
• First received: June 9, 2006
• Last updated: June 25, 2014
• Start date: June 2006
• Est. completion date: February 2008

Study information

• Verified date: June 2014
• Source: Vertex Pharmaceuticals Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Study the effectiveness of telaprevir (VX-950) in combination with Pegylated Interferon Alfa 2a (Peg-IFN-alfa-2a) and Ribavirin (RBV) in reducing plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels

Recruitment information / eligibility

• Status: Completed
• Enrollment: 263
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Hepatitis C virus Genotype 1 with detectable plasma hepatitis C virus RNA

• Have been infected with hepatitis C virus for greater than (>) 6 months

• Seronegative for hepatitis B surface antigen and Human Immunodeficiency Virus 1 and 2

• Must agree to use 2 methods of contraception, including 1 barrier method, during and for 24 weeks after the completion of the study (unless the subject is a female of documented non-child-bearing potential)

• Female subjects must have a negative pregnancy test at all visits before the first dose

Exclusion Criteria:

• Received any approved or investigational drug or drug regimen for the treatment of hepatitis C

• Any medical contraindications to Pegylated Interferon Alfa 2a or Ribavirin therapy

• 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

• Histologic evidence of hepatic cirrhosis (including compensated cirrhosis) based on a liver biopsy taken within 2 years before study start

• Alcohol abuse or excessive use in the last 12 months

• Participation in any investigational drug study 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

• Chronic Hepatitis C
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

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

Other:
• Placebo
matching placebo tablet

Locations

Country	Name	City	State
Puerto Rico	Fundacion de Investigacion de Diego	Santurce
United States	University of New Mexico	Albuquerque	New Mexico
United States	Inova Fairfax Hospital	Annandale	Virginia
United States	Call For Information	Baltimore	Maryland
United States	Gulf Coast Research Associates	Baton Rouge	Louisiana
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Call for Information	Boston	Massachusetts
United States	Call For Information	Chapel Hill	North Carolina
United States	University of Virginia Health System	Charlotteville	Virginia
United States	University of Chicago Medical Center	Chicago	Illinois
United States	University of Cincinnati College of Medicine	Cincinnati	Ohio
United States	Baylor University Medical Center	Dallas	Texas
United States	Methodist Hospital of Dallas	Dallas	Texas
United States	University of Texas Southwestern Medical Center at Dallas	Dallas	Texas
United States	University of Colorado Hospital	Denver	Colorado
United States	Henry Ford Health System	Detroit	Michigan
United States	Call For Information	Durham	North Carolina
United States	South Denver Gastroenterology	Englewood	Colorado
United States	Metropolitan Research	Fairfax	Virginia
United States	Shands Hospital University of Florida	Gainesville	Florida
United States	Clarian Hospital	Indianapolis	Indiana
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	Call For Information	Manhasset	New York
United States	Call for Information	Miami	Florida
United States	Froedtert Memorial Lutheran Hospital	Milwaukee	Wisconsin
United States	Call for Information	New York	New York
United States	Columbia University Medical Center	New York	New York
United States	Stanford University Liver Research	Palo Alto	California
United States	Fox Chase/ Temple Cancer Center	Philadelphia	Pennsylvania
United States	University of Pennsylvania Hospital	Philadelphia	Pennsylvania
United States	Call For Information	Phoenix	Arizona
United States	McGuire VA Medical Center	Richmond	Virginia
United States	Call For Information	Rochester	Minnesota
United States	Alamo Medical Research	San Antonio	Texas
United States	Call For Information	San Francisco	California
United States	Saint Louis University	St. Louis	Missouri
United States	Call For Information	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Vertex Pharmaceuticals Incorporated

Countries where clinical trial is conducted

United States,  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 Week 12 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).	12 weeks after the completion of study drug dosing (up to Week 60)	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 Week 48	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 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.	Day 1, 4, 8, 15, 22, 29, 43, 57, 71, 85	No