A Safety and Efficacy Study of the Combination of VX-222 and Telaprevir in Treatment-Naïve Subjects With Genotype 1 Chronic Hepatitis C Virus Infection

Chronic Hepatitis C Virus Infection Clinical Trial

Official title:

A Randomized, Parallel-Group, Dose-Ranging Study to Evaluate Efficacy, Safety, Pharmacokinetics, and Antiviral Activity of VX-222 and Telaprevir in Combination With and Without Peginterferon-Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Treatment-Naïve Subjects With Genotype 1 Chronic Hepatitis C

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01080222
• Other study ID #: VX09-222-103
• Status: Terminated
• Phase: Phase 2
• Start date: August 2010
• Est. completion date: November 2013

Study information

• Verified date: September 2020
• Source: Vertex Pharmaceuticals Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the safety and efficacy of combination treatment with VX-222 and telaprevir administered for 12 weeks with and without peginterferon-alfa-2a and/or ribavirin. The subjects enrolled in this study are chronically infected with hepatitis C virus (HCV) genotype 1 and will not have previously received treatment for their HCV infection.

This study will include an Investigational Phase and Extension Phase. These phases will contain a Treatment Period and a Follow-up Period. All subjects will be enrolled in the Investigational Phase of this study. Subjects who fail treatment during the Investigational Phase will have the option to enter the Extension Phase at which point they will be eligible to receive peginterferon alfa-2a and ribavirin for a total of 48 weeks.

Based on an evaluation of on-treatment safety, pharmacokinetic and antiviral data from patients in each arm of the trial, Vertex may elect to enroll up to two additional treatment arms (Treatment Arm E and Treatment Arm F) that will evaluate telaprevir/VX-222-based combination therapy. The components of the treatment regimens of these arms will be selected based on clinical data that emerges from the four initially-studied regimens. If enacted, up to 25 patients are expected to enroll in each additional treatment arm.

If Treatment Arm E or Treatment Arm F is discontinued subjects meeting certain criteria will have the option to enter a telaprevir-containing Rollover Phase. Subjects who do not meet the eligibility criteria to enter the Rollover Phase may elect to enter the Extension Phase.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 152
• Est. completion date: November 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Males and females of non-childbearing potential

• Genotype 1 chronic hepatitis C

• Laboratory evidence of HCV infection for 6 months

• Histologic evidence of chronic hepatitis C

• Subjects who have a body mass index (BMI) of =35 kg/m² (BMI = weight in kg / height² in meters)

• Treatment Arm E: This arm will enroll only subjects infected with HCV genotype 1b virus

• Treatment Arm F: This arm will enroll only subjects infected with HCV genotype 1a virus

Exclusion Criteria:

• Subjects who have received any previous treatment with any approved or investigational drug or drug regimen for the treatment of hepatitis C

• Subjects with any contraindications to peginterferon alfa-2a and/or ribavirin

• Subjects with any other cause of significant liver disease in addition to hepatitis C, which may include, but is not limited to malignancy with hepatic involvement, hepatitis B, drug or alcohol-related cirrhosis, autoimmune hepatitis, hemochromatosis, Wilson's disease, nonalcoholic steatohepatitis (NASH), or primary biliary cirrhosis

• Histologic evidence of hepatic cirrhosis

Related Conditions & MeSH terms

• Chronic Hepatitis C Virus Infection
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic
• Infection
• Virus Diseases

Intervention

Drug:
• telaprevir
tablet, 1125-mg, twice daily
• VX-222
capsule, 100-mg, twice daily
• ribavirin
tablet, 1000-mg for subjects weighing <75-kg or 1200-mg for subjects weighing =75-kg, twice daily

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

Drug:
• VX-222
capsule, 400-mg, twice daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Vertex Pharmaceuticals Incorporated

Countries where clinical trial is conducted

United States,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and Tolerability	Assessed by adverse events, physical examinations, vital signs, 12 lead electrocardiograms (ECGs), and laboratory assessments (serum chemistry, hematology, and urinalysis) vital signs, 12-lead electrocardiograms (ECGs), and laboratory assessments (clinical chemistry, hematology, and urinalysis)	40 weeks
Secondary	Proportion of Subjects Who Achieve a Sustained Viral Response		24 weeks after the completion of the last dose of the assigned study drug treatment regimen
Secondary	Undetectable HCV RNA Measurements	Time to undetectability; Proportion of subjects who achieve undetectable HCV RNA levels at Week 2, Week 4, Week 8, and Week 12; Proportion of subjects who achieve undetectable HCV RNA levels at Week 2 and Week 8; Proportion of subjects who have undetectable HCV RNA levels at the end of treatment	36 weeks
Secondary	Proportion of Subjects Who Have a Viral Breakthrough or Relapse		60 weeks
Secondary	Plasma Exposures of VX-222 and Telaprevir		12 weeks