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Phase 2 Study of VX-950, Pegasys® With and Without Copegus® in Hepatitis C

Information source: Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Hepatitis C

Intervention: Ribavirin (Drug); Pegylated Interferon Alfa 2a (Drug); Placebo (Drug); Telaprevir (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Vertex Pharmaceuticals Incorporated

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Vertex Pharmaceuticals Incorporated

Summary

Compare the effectiveness of telaprevir (VX-950) in combination with Pegylated Interferon Alfa 2a (Peg-IFN-alfa-2a) with and without Ribavirin (RBV) in reducing plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels

Clinical Details

Official title: A Phase 2 Study of VX-950 in Combination With Peginterferon Alfa-2a (Pegasys), With and Without Ribavirin (Copegus) in Subjects With Hepatitis C

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

Primary outcome: Percentage of Subjects With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 24 After the Completion of Study Drug Dosing

Secondary outcome:

Percentage of Subjects With Undetectable Plasma HCV RNA at Week 12 After the Completion of Study Drug Dosing

Percentage of Subjects With Undetectable Plasma HCV RNA at Completion of Study Drug Dosing

Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Number of Subjects With Viral Relapse

Maximum (Cmax), Minimum (Cmin) and Average (Cavg) Plasma Concentration of Telaprevir

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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 Peg-IFN-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/drug 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).

Locations and Contacts

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Additional Information

Starting date: August 2006
Last updated: June 25, 2014

Page last updated: August 23, 2015

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