A Study to Evaluate the Efficacy and Safety of Quadruple Therapy (VX-222, Telaprevir,Peginterferon-Alfa-2a, Ribavirin) in Subjects With Chronic Hepatitis C With Compensated Cirrhosis

Chronic Hepatitis C Virus Clinical Trial

Official title:

A Multicenter, Open-Label Phase 2b Pilot Study to Evaluate the Efficacy and Safety of Quadruple Therapy (VX-222, Telaprevir, Peginterferon-Alfa-2, and Ribavirin) in Subjects With Genotype 1 Chronic Hepatitis C With Compensated Cirrhosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01516918
• Other study ID #: VX11-222-106
• Status: Completed
• Phase: Phase 2
• First received: January 13, 2012
• Last updated: October 9, 2014
• Start date: February 2012
• Est. completion date: December 2013

Study information

• Verified date: October 2014
• Source: Vertex Pharmaceuticals Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health CanadaGermany: Federal Institute for Drugs and Medical DevicesPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and efficacy of a quadruple regimen (VX-222, telaprevir, pegylated interferon, and ribavirin)in subjects with hepatitis C with cirrhosis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: December 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Subjects must have genotype 1 Chronic Hepatitis C

• Subjects must have compensated cirrhosis

• Subjects may either be treatment naïve, or may have received a course of Peg IFN/RBV without evidence of response. Subjects who are considered to be relapsers to Peg IFN/RBV, or who are partial or null responders will be considered

• Subjects with hemophilia may be permitted to enroll with permission of the medical monitor

Exclusion Criteria:

• Any previous treatment with an investigational drug or drug regimen for the treatment of hepatitis C, or previous treatment with an approved protease inhibitor

• Any contraindication to Peg-IFN or RBV therapy

• Evidence of hepatic decompensation: history of ascites, hepatic encephalopathy, or bleeding esophageal varices

• A history of acquired immunodeficiency infection, organ transplantation or have an ongoing requirement for immunosuppressive medicines

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis C Virus
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic
• Liver Cirrhosis

Intervention

Drug:
• VX-222
tablet, 400-mg twice daily
• telaprevir
tablet, 1125-mg twice daily
• ribavirin
tablet, 1000-mg per day for subjects weighing <75 kg and 1200 mg per day for subjects weighing =75 kg, twice daily

Biological:
• peginterferon-alfa-2a
subcutaneous injection, 180-mcg, once weekly

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Vertex Pharmaceuticals Incorporated

Countries where clinical trial is conducted

United States,  Canada,  Germany,  Poland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of subjects who have a sustained virologic response at 12 weeks after the last planned dose of treatment (SVR12)		12 weeks	No
Secondary	The safety and tolerability as assessed by adverse events, vital signs, 12-lead electrocardiograms and laboratory assessments.		up to 48 weeks	Yes
Secondary	The proportion of subjects who have an SVR 24 weeks after the last planned dose of the study drug (SVR24)		24 weeks	No
Secondary	The proportion of subjects who achieve undetectable HCV RNA at Weeks 2, 4, 8, and 12 after the first dose of study drug, and at the end of planned study drug treatment		up to week 12	No
Secondary	The proportion of subjects who have on-treatment virologic failure defined as subjects who either meet a futility rule or who complete the assigned treatment duration and have HCV RNA at the end of study drug treatment		up to 48 weeks	No
Secondary	The association of the IL-28B genotype with SVR12	Proportion of subjects who have SVR12 by IL-28B genotype	12 weeks	No
Secondary	The amino acid sequence of the nonstructural (NS)3 and NS5B proteins in subjects who have treatment failure	The identity and observed frequency of viral variants as compared to wild-type virus will be measured.	After the last planned dose of study drug or after time of failure	No
Secondary	VX-222, telaprevir, and RBV plasma concentrations and Peg-IFN serum concentrations		12 weeks	No