Clinical trial NCT01467492: Telaprevir, Peg-IFN-alfa-2a, and RBV in Treatment-Experienced Black/African American and Non-Black/African American Subjects With Genotype 1 Chronic Hepatitis C
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Hepatitis C
Keywords: VX-950, Incivek
Lead sponsor: Vertex Pharmaceuticals Incorporated
Sponsor class: INDUSTRY
First posted: 2011-11-08
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of telaprevir in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) and ribavirin (RBV) in treatment-experienced Black/African American and non-Black/African American participants with Genotype 1 Chronic Hepatitis C (CHC), who have not achieved a sustained viral response with a prior course of interferon-based therapy.

Detailed description: This is a single-arm, open-label, multicenter study of treatment-experienced participants with Genotype 1 CHC, who self-identified as Black/African American (Group A) or who did not self-identify as Black/African American (Group B). Participants did not achieve a sustained virologic response 24 weeks after at least 1 prior course of Peg-IFN-alfa-2a/RBV therapy of standard duration, and have 1 of the following viral responses:

* Prior relapse: Participant had a documented undetectable hepatitis C virus ribonucleic acid (HCV RNA) level at the planned end of treatment of at least 42 weeks duration (HCV RNA evaluated anytime between 3 weeks before and 6 weeks after the last dose of Peg IFN-alfa-2a or RBV).
* Prior null response: Participant had a \<2-log10 decrease in HCV RNA at 12 weeks, during prior Peg IFN-alfa-2a/RBV treatment, but never achieved undetectable HCV RNA while on treatment.
* Prior partial response: Participant had a \>=2-log10 decrease in HCV RNA at 12 weeks, during prior Peg IFN-alfa-2a/RBV treatment, but never achieved undetectable HCV RNA while on treatment.

Eligibility criteria: Inclusion Criteria:

* Participants self-identify as Black/African American (Group A) or did not self-identify as Black/African American (Group B)
* Participants have Genotype 1 CHC and laboratory evidence of hepatitis C virus (HCV) infection for at least 6 months
* Participants did not achieve sustained viral response 24 weeks after last dose of study drug (SVR24), after at least 1 prior course of Peg-IFN-alfa-2a/RBV therapy of standard duration

Exclusion Criteria:

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

Primary outcomes:
measure: Percentage of Participants With Sustained Viral Response 12 Weeks After Last Actual Dose of Study Drug (SVR12)
timeFrame: 12 weeks after last actual dose of study drug (up to Week 60)
Secondary outcomes:
measure: Percentage of Participants With Sustained Viral Response 24 Weeks After Last Actual Dose of Study Drug (SVR24)
timeFrame: 24 weeks after last actual dose of study drug (up to Week 72)
measure: Percentage of Participants With Extended Rapid Viral Response (eRVR)
timeFrame: Week 4 and Week 12
measure: Percentage of Participants With Relapse
timeFrame: 4 weeks (Wk) (up to Week 52), 12 weeks (up to Week 60) and 24 weeks (up to Week 72) after actual EOT
measure: Percentage of Participants With Virologic Breakthrough
timeFrame: Week 2, 4, 8, and 12
measure: Percentage of Participants With On Treatment Virologic Failure
timeFrame: Week 2, 4, 8, 12, 16, 24, 28, 36, 40, and 48
measure: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Up to Week 52
measure: Number of Participants With Telaprevir Resistant HCV Variant at Non-Structural Viral Protein 3-4A (NS3-4A) Region
timeFrame: up to Week 72
Other outcomes:
measure: Plasma Concentration of Telaprevir, Peginterferon Alfa-2a (Peg-IFN) and Ribavirin (RBV)
timeFrame: 48 weeks
Locations:
city: Birmingham
country: United States
facility: Alabama
state: Alabama
city: San Francisco
country: United States
facility: California
state: California
city: New Haven
country: United States
facility: Connecticut
state: Connecticut
city: Washington
country: United States
facility: Washington, DC
state: District of Columbia
city: Miami
country: United States
facility: Florida
state: Florida
city: Orlando
country: United States
facility: Florida
state: Florida
city: Tampa
country: United States
facility: Florida
state: Florida
city: West Palm Beach
country: United States
facility: Florida
state: Florida
city: Atlanta
country: United States
facility: Georgia
state: Georgia
city: Chicago
country: United States
facility: Illinois
state: Illinois
city: Baton Rouge
country: United States
facility: Louisiana
state: Louisiana
city: New Orleans
country: United States
facility: Louisiana
state: Louisiana
city: Shreveport
country: United States
facility: Louisiana
state: Louisiana
city: Baltimore
country: United States
facility: Maryland
state: Maryland
city: Boston
country: United States
facility: Massachusetts
state: Massachusetts
city: Detroit
country: United States
facility: Michigan
state: Michigan
city: Vineland
country: United States
facility: New Jersey
state: New Jersey
city: Bronx
country: United States
facility: New York
state: New York
city: New York
country: United States
facility: New York
state: New York
city: Charlotte
country: United States
facility: North Carolina
state: North Carolina
city: Durham
country: United States
facility: North Carolina
state: North Carolina
city: Philadelphia
country: United States
facility: Pennsylvania
state: Pennsylvania
city: Dallas
country: United States
facility: Texas
state: Texas
city: Houston
country: United States
facility: Texas
state: Texas
city: San Antoinio
country: United States
facility: Texas
state: Texas
city: Norfolk
country: United States
facility: Virginia
state: Virginia
city: Seattle
country: United States
facility: Washington
state: Washington
Study officials:
affiliation: Vertex Pharmaceuticals Incorporated
name: Medical Monitor
role: STUDY_DIRECTOR
References: