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

Purpose

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.

Condition	Intervention	Phase
Chronic Hepatitis C Virus	Drug: VX-222 Drug: telaprevir Drug: ribavirin	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis C

Drug Information available for: Ribavirin Telaprevir

U.S. FDA Resources

Further study details as provided by Vertex Pharmaceuticals Incorporated:

Primary Outcome Measures:

The proportion of subjects who have a sustained viral response at 12 weeks after the last planned dose of treatment [ Time Frame: 12 weeks after the last planned dose of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The safety and tolerability as assessed by adverse events (AEs), vital signs, 12-lead electrocardiograms (ECGs), and laboratory assessments (serum chemistry, hematology, and urinalysis) [ Time Frame: up to 20 weeks ] [ Designated as safety issue: Yes ]
The proportion of subjects who have an SVR 24 weeks after the last planned dose of the study drug [ Time Frame: 24 weeks after the last planned dose of the study drug ] [ Designated as safety issue: No ]
The proportion of subjects who have an SVR 4 weeks after the last planned dose of the study drug [ Time Frame: 4 weeks after the last planned dose of the study drug ] [ Designated as safety issue: No ]
The proportion of subjects who relapse (i.e., who had <LLOQ HCV RNA at the end of planned study drug treatment (planned EOT) followed by ≥LLOQ HCV RNA after planned EOT) [ Time Frame: 48 weeks either after the last planned dose of study drug or after time of failure ] [ Designated as safety issue: No ]
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) [ Time Frame: up to 16 weeks ] [ Designated as safety issue: No ]
Time to achieve <LLOQ undetectable HCV RNA [ Time Frame: up to 16 weeks ] [ Designated as safety issue: No ]
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) [ Time Frame: up to 16 weeks ] [ Designated as safety issue: No ]
The association of the IL-28B genotype (CC versus CT versus TT) with SVR12 [ Time Frame: 12 weeks after the last planned dose of treatment ] [ Designated as safety issue: No ]
The amino acid sequence of the nonstructural (NS)3/4A and NS5B proteins in subjects who have treatment failure [ Time Frame: 48 weeks either after the last planned dose of study drug or after time of failure ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	May 2012
Estimated Primary Completion Date:	February 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 12 week treatment	Drug: VX-222 400 mg tablets twice daily for oral administration Drug: telaprevir 1125 mg tablets twice daily for oral administration Other Name: VX-950, INCIVEK, INCIVO, TELAVIC Drug: ribavirin 1000 mg per day for subjects weighing <75 kg and 1200 mg per day for subjects weighing ≥75 kg, dosed twice daily Other Name: Copegus
Experimental: 16 week treatment	Drug: VX-222 400 mg tablets twice daily for oral administration Drug: telaprevir 1125 mg tablets twice daily for oral administration Other Name: VX-950, INCIVEK, INCIVO, TELAVIC Drug: ribavirin 1000 mg per day for subjects weighing <75 kg and 1200 mg per day for subjects weighing ≥75 kg, dosed twice daily Other Name: Copegus

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects must have genotype 1 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01581138

Locations

United States, Alabama

Birmingham, Alabama, United States
United States, California

Anaheim, California, United States

Riverside, California, United States

San Diego, California, United States
United States, Colorado

Englewood, Colorado, United States
United States, Florida

Orlando, Florida, United States
United States, Georgia

Marietta, Georgia, United States
United States, Maryland

Baltimore, Maryland, United States
United States, New York

New York, New York, United States
United States, North Carolina

Asheville, North Carolina, United States

Winston-Salem, North Carolina, United States
United States, Ohio

Cincinatti, Ohio, United States
United States, Pennsylvania

Pittsburgh, Pennsylvania, United States
United States, Tennessee

Germantown, Tennessee, United States

Nashville, Tennessee, United States
United States, Texas

Austin, Texas, United States

San Antonio, Texas, United States
United States, Virginia

Norfolk, Virginia, United States

Sponsors and Collaborators

Vertex Pharmaceuticals Incorporated

Investigators

Study Director:

Medical Monitor

Vertex Pharmaceuticals Incorporated

More Information

No publications provided

Responsible Party:	Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier:	NCT01581138 History of Changes
Other Study ID Numbers:	VX11-222-108
Study First Received:	April 17, 2012
Last Updated:	September 5, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections

Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Ribavirin
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 17, 2012