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.
Brief Title
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
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.
* 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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Hepatitis C
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
* 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
Inclusion 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
* 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
Gender
All
Gender Based
false
Keywords
VX-950, Incivek
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Estimated
Last Update Submit Date
Maximum Age
70 Years
Minimum Age
18 Years
NCT Id
NCT01467492
Org Class
Industry
Org Full Name
Vertex Pharmaceuticals Incorporated
Org Study Id
VX11-950-116
Overall Status
Terminated
Phases
Phase 4
Primary Completion Date
Primary Completion Date Type
Actual
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
Primary Outcomes
Outcome Description
SVR12 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (\<lower limit of quantification) at 12 weeks after last actual dose of study drug. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL).
Outcome Measure
Percentage of Participants With Sustained Viral Response 12 Weeks After Last Actual Dose of Study Drug (SVR12)
Outcome Time Frame
12 weeks after last actual dose of study drug (up to Week 60)
Secondary Outcomes
Outcome Description
SVR24 was defined as an undetectable HCV RNA Levels (\<lower limit of quantification) at 24 weeks after last actual dose of study drug. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL.
Outcome Time Frame
24 weeks after last actual dose of study drug (up to Week 72)
Outcome Measure
Percentage of Participants With Sustained Viral Response 24 Weeks After Last Actual Dose of Study Drug (SVR24)
Outcome Description
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 (\<lower limit of quantification) at both 4 weeks and 12 weeks after the start of study treatment.
Outcome Time Frame
Week 4 and Week 12
Outcome Measure
Percentage of Participants With Extended Rapid Viral Response (eRVR)
Outcome Description
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 (\<lower limit of quantification) at actual end of treatment (EOT) and followed by detectable HCV RNA (\>=lower limit of quantification) during follow-up.
Outcome Time Frame
4 weeks (Wk) (up to Week 52), 12 weeks (up to Week 60) and 24 weeks (up to Week 72) after actual EOT
Outcome Measure
Percentage of Participants With Relapse
Outcome Description
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 (\<lower limit of quantification). Percentages are calculated by using total number in FA set as denominator, in each category.
Outcome Time Frame
Week 2, 4, 8, and 12
Outcome Measure
Percentage of Participants With Virologic Breakthrough
Outcome Description
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.
Outcome Time Frame
Week 2, 4, 8, 12, 16, 24, 28, 36, 40, and 48
Outcome Measure
Percentage of Participants With On Treatment Virologic Failure
Outcome Description
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.
Outcome Time Frame
Up to Week 52
Outcome Measure
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Outcome Description
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.
Outcome Time Frame
up to Week 72
Outcome Measure
Number of Participants With Telaprevir Resistant HCV Variant at Non-Structural Viral Protein 3-4A (NS3-4A) Region
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
70
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
John Reinus
Investigator Email
jreinus@montefiore.org
Investigator Phone