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

Hepatitis C Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01467492
• Other study ID #: VX11-950-116
• Status: Terminated
• Phase: Phase 4
• First received: November 3, 2011
• Last updated: July 13, 2015
• Start date: January 2012
• Est. completion date: May 2014

Study information

• Verified date: June 2015
• 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 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 121
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Telaprevir
Tablet
• Ribavirin
Tablet

Biological:
• Pegylated Interferon Alfa-2a
Subcutaneous Injection

Locations

Country	Name	City	State
United States	Georgia	Atlanta	Georgia
United States	Maryland	Baltimore	Maryland
United States	Louisiana	Baton Rouge	Louisiana
United States	Alabama	Birmingham	Alabama
United States	Massachusetts	Boston	Massachusetts
United States	New York	Bronx	New York
United States	North Carolina	Charlotte	North Carolina
United States	Illinois	Chicago	Illinois
United States	Texas	Dallas	Texas
United States	Michigan	Detroit	Michigan
United States	North Carolina	Durham	North Carolina
United States	Texas	Houston	Texas
United States	Florida	Miami	Florida
United States	Connecticut	New Haven	Connecticut
United States	Louisiana	New Orleans	Louisiana
United States	New York	New York	New York
United States	Virginia	Norfolk	Virginia
United States	Florida	Orlando	Florida
United States	Pennsylvania	Philadelphia	Pennsylvania
United States	Texas	San Antoinio	Texas
United States	California	San Francisco	California
United States	Washington	Seattle	Washington
United States	Louisiana	Shreveport	Louisiana
United States	Florida	Tampa	Florida
United States	New Jersey	Vineland	New Jersey
United States	Washington, DC	Washington	District of Columbia
United States	Florida	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Vertex Pharmaceuticals Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Plasma Concentration of Telaprevir, Peginterferon Alfa-2a (Peg-IFN) and Ribavirin (RBV)		48 weeks	No
Primary	Percentage of Participants With Sustained Viral Response 12 Weeks After Last Actual Dose of Study Drug (SVR12)	SVR12 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (	12 weeks after last actual dose of study drug (up to Week 60)	No
Secondary	Percentage of Participants With Sustained Viral Response 24 Weeks After Last Actual Dose of Study Drug (SVR24)	SVR24 was defined as an undetectable HCV RNA Levels (	24 weeks after last actual dose of study drug (up to Week 72)	No
Secondary	Percentage of Participants With Extended Rapid Viral Response (eRVR)	The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL. eRVR was defined as undetectable HCV RNA (	Week 4 and Week 12	No
Secondary	Percentage of Participants With Relapse	The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL. Relapse was defined as having undetectable HCV RNA (	4 weeks (Wk) (up to Week 52), 12 weeks (up to Week 60) and 24 weeks (up to Week 72) after actual EOT	No
Secondary	Percentage of Participants With Virologic Breakthrough	The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL. Virologic breakthrough on treatment was defined as an increase of at least 1 log10 from nadir or confirmed detectable HCV RNA (>=lower limit of quantification) after undetectable HCV RNA (	Week 2, 4, 8, and 12	No
Secondary	Percentage of Participants With On Treatment Virologic Failure	On treatment virologic failure was defined as meeting any futility rule or completing assigned treatment duration and having detectable HCV RNA at EOT. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL. Futility rules: 1) Virologic breakthrough (at least 1 log10 increase from nadir or confirmed detectable HCV RNA after undetectable HCV RNA) from Day 1 through Week 24 or 48 (depending on treatment duration); 2) HCV RNA >1000 IU/mL during Weeks 4 to 12, inclusive; 3) Detectable HCV RNA after Week 12. Percentages are calculated by using total number in FA set as denominator, in each category.	Week 2, 4, 8, 12, 16, 24, 28, 36, 40, and 48	No
Secondary	Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	AE: any untoward medical occurrence in a participant during the study; the event does not necessarily have a causal relationship with the treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after the informed consent form is signed. AE includes SAE as well as Non-SAEs. SAE (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event.	Up to Week 52	Yes
Secondary	Number of Participants With Telaprevir Resistant HCV Variant at Non-Structural Viral Protein 3-4A (NS3-4A) Region	Sequence analysis of the HCV NS3-4A region was performed to monitor telaprevir-resistant variants. HCV RNA was isolated from the plasma, amplified by reverse transcription-polymerase chain reaction (RT-PCR), and sequenced (sequencing assay limit of detection HCV RNA >=1000 IU/mL). Results of this outcome measure were to be reported for overall participants instead of by race and by prior response.	up to Week 72	No