Telaprevir in Combination With Peginterferon and Ribavirin in Treatment-experienced Black/African American Subjects. - Full Text View

Purpose

The purpose of this study is to collect additional data in treatment-experienced Black/African Americans that can be used to guide treatment decisions in this patient population.

Condition	Intervention	Phase
Hepatitis C	Drug: Telaprevir Drug: ribavirin Biological: peginterferon alfa-2a	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	An Open-Label, Phase 4 Study of Telaprevir, Peginterferon Alfa-2a (Pegasys®), and Ribavirin (Copegus®) in Treatment-Experienced Black/African American and Non-Black/African American Subjects With Genotype 1 Chronic Hepatitis C Who Have Not Achieved a Sustained Viral Response With a Prior Course of Interferon-Based Therapy

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis C

Drug Information available for: Interferon Ribavirin Peginterferon Alfa-2a Telaprevir

U.S. FDA Resources

Further study details as provided by Vertex Pharmaceuticals Incorporated:

Primary Outcome Measures:

Proportion of subjects who achieve SVR 12 weeks after last actual dose of study drug, by prior response. [ Time Frame: 12 weeks after last actual dose of study drug ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportion of subjects who achieve SVR 24 weeks after last actual dose of study drug by prior response. [ Time Frame: 24 weeks after last actual dose of study drug ] [ Designated as safety issue: No ]
Proportion of subjects who achieve undetectable HCV RNA at Week 4 and at Week 12 (eRVR) by prior response [ Time Frame: up to Week 12 ] [ Designated as safety issue: No ]
Proportion of subjects who relapse, overall and by treatment completion status, defined as having undetectable HCV RNA at actual end of treatment followed by detectable HCV RNA during follow-up, by prior response [ Time Frame: up to Week 72 ] [ Designated as safety issue: No ]
Proportion of subjects who have on-treatment virologic failure, defined as meeting futility rule or completing assigned treatment duration and having detectable HCV RNA at the end of treatment, prior response. [ Time Frame: up to Week 48 ] [ Designated as safety issue: No ]
Safety as indicated by adverse events, clinical laboratory results, electrocardiograms and vital signs [ Time Frame: up to Week 52 ] [ Designated as safety issue: Yes ]
Amino acid sequence of the HCV NS34A protease region [ Time Frame: Baseline up through 48 weeks after subject becomes detectable ] [ Designated as safety issue: No ]
Pharmacokinetics of telaprevir, Peg-IFN and RBV [ Time Frame: up to Week 12 ] [ Designated as safety issue: No ]
Proportion of subjects who experience viral breakthrough,defined as having ≥1 log increase from nadir or confirmed detectable HCV RNA after undetectable HCV RNA, by prior response. [ Time Frame: up to 48 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	220
Study Start Date:	January 2012
Estimated Primary Completion Date:	May 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Relapsers (eRVR+) Relapsers (eRVR+):Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks followed by Peg-IFN-alfa-2a + RBV for 12 weeks eRVR+: undetectable HCV RNA at Weeks 4 and 12	Drug: Telaprevir 1125mg tablets for 12 weeks Other Name: Incivek, VX-950 Drug: ribavirin 1000mg-1200mg based on body weight for 24 weeks Other Name: Copegus Biological: peginterferon alfa-2a 180 mcg/week for 24 weeks Other Name: Pegasys
Experimental: Relapsers (eRVR-) Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by Peg-IFN-alfa-2a + RBV for 36 weeks eRVR-: undetectable HCV RNA at Weeks 4 and 12	Drug: Telaprevir 1125mg tablets for 12 weeks Other Name: Incivek, VX-950 Drug: ribavirin 1000mg-1200mg based on body weight for 48 weeks Other Name: Copegus Biological: peginterferon alfa-2a 180 mcg/week for 48 weeks Other Name: Pegasys
Experimental: Null/Partial All Null/Partial subjects receive Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by Peg-IFN-alfa-2a + RBV for 36 weeks	Drug: Telaprevir 1125mg tablets for 12 weeks Other Name: Incivek, VX-950 Drug: ribavirin 1000mg-1200mg based on body weight for 48 weeks Other Name: Copegus Biological: peginterferon alfa-2a 180 mcg/week for 48 weeks Other Name: Pegasys
Experimental: Other Subjects who received at least 1 dose of study drug, but prematurely discontinued treatment before Week 12	Drug: Telaprevir 1125mg tablets for 12 weeks Other Name: Incivek, VX-950 Drug: ribavirin 1000mg-1200mg based on body weight for either 24 or 48 weeks Other Name: Copegus Biological: peginterferon alfa-2a 180 mcg/week for either 24 or 48 weeks Other Name: Pegasys

Eligibility

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

Criteria

Inclusion Criteria:

Male and female subjects, 18 to 70 years of age, inclusive
Subjects self-identify as Black/African American
Subjects have genotype 1 CHC and laboratory evidence of HCV infection for at least 6 months
Subjects did not achieve SVR24 after at least 1 prior course of Peg-IFN/RBV therapy of standard duration

Exclusion Criteria:

Subjects have received previous treatment with telaprevir or any other protease inhibitor(s) for CHC
Subjects who have evidence of hepatic decompensation
Subjects have diagnosed or suspected hepatocellular carcinoma
Subjects have any other cause of significant liver disease in addition to HCV
Subjects are currently abusing illicit drugs or alcohol, or have history of illicit substance or alcohol abuse within 2 years before the screening visit
Subjects who participated in any investigational drug study within 90 days before dosing

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01467492

Show 27 Study Locations

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:	NCT01467492 History of Changes
Other Study ID Numbers:	VX11-950-116
Study First Received:	November 3, 2011
Last Updated:	January 2, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Vertex Pharmaceuticals Incorporated:

VX-950, Incivek

Additional relevant MeSH terms:

Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections

Ribavirin
Peginterferon alfa-2a
Interferon-alpha
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 21, 2013