VX-222 + Telaprevir + Ribavirin for 12 or 16 Weeks in Treatment-Naive Subjects With Genotype 1a Hepatitis C

Chronic Hepatitis C Virus Clinical Trial

Official title:

A Multicenter, Randomized, Open-label, Phase 2b Study to Evaluate the Efficacy and Safety of Two Regimens of All-oral Triple Therapy (VX-222 in Combination With Telaprevir [Incivek™] and Ribavirin [Copegus®]) in Treatment-Naïve Subjects With Genotype 1a Chronic Hepatitis C

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01581138
• Other study ID #: VX11-222-108
• Status: Completed
• Phase: Phase 2
• First received: April 17, 2012
• Last updated: July 2, 2014
• Start date: July 2012
• Est. completion date: December 2013

Study information

• Verified date: July 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

The purpose of this study is to evaluate the efficacy and safety of two all oral regimens in subjects who have chronic hepatitis C and have not received treatment yet.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: December 2013
• Est. primary completion date: June 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 (CHC) and laboratory evidence of HCV infection for at least 6 months before the Screening Visit

• Subjects will be treatment naïve

• Subjects must have documentation of the presence or absence of cirrhosis

Exclusion Criteria:

• History or other clinical evidence of significant or unstable cardiac disease

• Evidence of hepatic decompensation

• Diagnosed or suspected hepatocellular carcinoma

• 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, or primary biliary cirrhosis

• History of organ transplant, with the exception of corneal transplants and skin grafts

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel 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

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Vertex Pharmaceuticals Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of subjects who have a sustained viral response (SVR) at 12 weeks after the last planned dose of treatment		12 weeks after the last planned dose of treatment	No
Secondary	The safety and tolerability as assessed by adverse events (AEs), vital signs, 12-lead electrocardiograms (ECGs), and laboratory assessments (serum chemistry, hematology, and urinalysis)		up to 20 weeks	Yes
Secondary	The proportion of subjects who have an SVR 24 weeks after the last planned dose of the study drug		24 weeks after the last planned dose of the study drug	No
Secondary	The proportion of subjects who have an SVR 4 weeks after the last planned dose of the study drug		4 weeks after the last planned dose of the study drug	No
Secondary	The proportion of subjects who relapse (i.e., who had <lower limit of quantitation LLOQ hepatitis C virus (HCV) RNA at the end of planned study drug treatment (planned EOT) followed by =LLOQ HCV RNA after planned EOT)		48 weeks either after the last planned dose of study drug or after time of failure	No
Secondary	The proportion of subjects who achieve undetectable HCV RNA (below the lower limit of detection (< (LLOQ) undetectable) at Weeks 2, 4, 8, 12, and 16 after the first dose of study drug, and <LLOQ at the end of planned study drug treatment (planned EOT)		up to 16 weeks	No
Secondary	Time to achieve <LLOQ undetectable HCV RNA		up to 16 weeks	No
Secondary	The proportion of subjects who have on-treatment virologic failure defined as subjects who either have viral breakthrough or who complete the assigned treatment and have =LLOQ HCV RNA at the end of study drug treatment (EOT)		up to 16 weeks	No
Secondary	The association of the interleukin-28B (IL-28B) genotype (CC versus CT versus TT) with SVR12		12 weeks after the last planned dose of treatment	No
Secondary	The amino acid sequence of the nonstructural (NS)3/4A and NS5B proteins in subjects who have treatment failure		48 weeks either after the last planned dose of study drug or after time of failure	No