Back to resultsEfficacy of a 12-Week Regimen of Telaprevir, Pegylated Interferon, and Ribavirin in Treatment-Naive and Prior Relapser Subjects With Interleukin28B (IL28B) CC Genotype (CONCISE)
Primary Purpose
Hepatitis C, Chronic
Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Telaprevir
Pegylated Interferon Alfa-2a
Ribavirin
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis C, Chronic focused on measuring VX-950, INCIVEK, INCIVO
Eligibility Criteria
Inclusion Criteria:
- Male and female subjects, 18 to 70 years of age, inclusive
- Treatment-naive OR subjects (prior relapsers) may be included who did not achieve sustained viral response 24 weeks after last planned dose of study drug (SVR24) after at least 1 prior course of Peg-IFN/RBV therapy of standard duration and had a documented undetectable HCV RNA level at the planned end of treatment of at least 42-week duration
- Subjects have IL28B CC genotype determined during screening
- Subjects have genotype 1 chronic hepatitis C and laboratory evidence of HCV infection for at least 6 months, defined by (1) documented HCV serology test at least 6 months before the first screening visit demonstrating the presence of anti-HCV antibody, or (2) documented presence of HCV RNA by a sensitive and specific assay at least 6 months before the first screening visit, or (3) documented histologic evidence of chronic hepatitis C demonstrated by fibrosis on a standardized histologic grading system at least 6 months before the first screening visit. If only inflammation is present in the liver histologic report, then 6 months of laboratory evidence is required
Exclusion Criteria:
- Subjects have received previous treatment with telaprevir or any other protease inhibitor(s) for chronic hepatitis C
- Subjects who did not achieve SVR24 after at least 1 prior course of Peg-IFN/RBV therapy of standard duration and never achieved undetectable HCV RNA while on treatment
- Subjects have evidence of hepatic decompensation
- Subjects have evidence of cirrhosis
- Subjects have diagnosed or suspected hepatocellular carcinoma
- Subjects have 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. Steatosis is allowed if clinically asymptomatic
Sites / Locations
- California
- California
- Pennsylvania
- Virginia
- Israel
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)
Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)
Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Non Randomized)
Telaprevir 12 Wk +Peg-IFN-alfa-2a,RBV 48 Wk (Non Randomized)
Arm Description
Telaprevir 1125 milligram (mg) tablet twice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met rapid viral response (RVR, undetectable Hepatitis C Virus [HCV] Ribonucleic Acid [RNA] at Week 4) criteria, were randomized in this group, as planned, and did not receive any further treatment.
Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.
Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, and had extended rapid viral response (eRVR, undetectable HCV RNA at Weeks 4 and 12), were included in this group, as planned.
Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Only subjects with no RVR or no RVR assessment, and subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, who did not have eRVR or eRVR assessment, were included in this group, as planned.
Outcomes
Primary Outcome Measures
Percentage of Subjects With Sustained Viral Response 12 Weeks After Last Planned Dose of Study Drug (SVR12)
SVR12 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at 12 weeks after last planned 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) and the lower limit of detection was 10 IU/mL. This outcome was planned to be assessed only in "Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)" and "Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)" reporting groups.
Secondary Outcome Measures
Percentage of Subjects With Sustained Viral Response 4 Weeks After Last Planned Dose of Study Drug (SVR4)
SVR4 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at 4 weeks after last planned dose of study treatment. 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) and the lower limit of detection was 10 IU/mL. This outcome was planned to be assessed only in "Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)" and "Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)" reporting groups.
Percentage of Subjects With Sustained Viral Response 24 Weeks After Last Planned Dose of Study Drug (SVR24)
SVR24 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at 24 weeks after last planned dose of study treatment. 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) and the lower limit of detection was 10 IU/mL. This outcome was planned to be assessed only in "Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)" and "Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)" reporting groups.
Percentage of Subjects With Sustained Viral Response at Week 72 (SVR72)
SVR72 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Week 72. 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) and the lower limit of detection was 10 IU/mL. This outcome was planned to be assessed only in "Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)" and "Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)" reporting groups.
Percentage of Subjects With Viral Relapse
Viral relapse was defined as having detectable HCV RNA during antiviral follow-up in subjects who had HCV RNA less than (<) lower limit of quantification (LLOQ) at end of treatment. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The LLOQ was 25 IU/mL and the lower limit of detection was 10 IU/mL. This outcome was planned to be assessed only in "Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)" and "Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)" reporting groups.
Percentage of Subjects With On-Treatment Virologic Failure
On-treatment virologic failure was defined as subjects who met futility (as per investigator discretion) or who completed the assigned treatment duration and had detectable HCV RNA at planned end of treatment (up to 48 weeks). This outcome was planned to be assessed in all reporting groups and results were to be reported for total arm as well.
Number of Subjects With Rapid Viral Response (RVR)
The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. RVR was defined as undetectable HCV RNA 4 weeks after the start of study treatment. This outcome was planned to be assessed only in "Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)" and "Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)" reporting groups.
Number of Subjects 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 and the lower limit of detection was 10 IU/mL. eRVR was defined as undetectable HCV RNA at both 4 weeks and 12 weeks after the start of study treatment. This outcome was planned to be assessed only in "Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)" and "Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)" reporting groups.
Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AE: any adverse change from the subject's baseline (pre-treatment) condition, including any adverse experience, abnormal recording or clinical laboratory assessment value which occurs during the course of the study, whether it is considered related to the study drug or not. An adverse event includes any newly occurring event or previous condition that has increased in severity or frequency since the administration of study drug. SAE: 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. "Study drug" includes all investigational agents administered during the course of the study.
Full Information
NCT ID
NCT01459913
First Posted
October 24, 2011
Last Updated
May 14, 2015
Sponsor
Vertex Pharmaceuticals Incorporated
1. Study Identification
Unique Protocol Identification Number
NCT01459913
Brief Title
Efficacy of a 12-Week Regimen of Telaprevir, Pegylated Interferon, and Ribavirin in Treatment-Naive and Prior Relapser Subjects With Interleukin28B (IL28B) CC Genotype
Acronym
CONCISE
Official Title
A Phase 3b Study of 2 Treatment Durations of Telaprevir, Peg-IFN (Pegasys®), and Ribavirin (Copegus®) in Treatment-Naive and Prior Relapser Subjects With Genotype 1 Chronic Hepatitis C and IL28B CC Genotype
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Terminated
Why Stopped
The study was terminated early by the sponsor on 13 January 2014 due to a decision to modify the drug development plan.
Study Start Date
November 2011 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vertex Pharmaceuticals Incorporated
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate if a 12-week total regimen of telaprevir in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) and ribavirin (RBV) (T12/PR12) is safe and effective in subjects who have the interleukin-28B (IL28B) CC genotype. The subjects enrolled in this study will have chronic hepatitis C virus (HCV) infection and will not have cirrhosis of the liver.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Chronic
Keywords
VX-950, INCIVEK, INCIVO
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
239 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)
Arm Type
Experimental
Arm Description
Telaprevir 1125 milligram (mg) tablet twice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met rapid viral response (RVR, undetectable Hepatitis C Virus [HCV] Ribonucleic Acid [RNA] at Week 4) criteria, were randomized in this group, as planned, and did not receive any further treatment.
Arm Title
Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)
Arm Type
Experimental
Arm Description
Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.
Arm Title
Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Non Randomized)
Arm Type
Experimental
Arm Description
Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, and had extended rapid viral response (eRVR, undetectable HCV RNA at Weeks 4 and 12), were included in this group, as planned.
Arm Title
Telaprevir 12 Wk +Peg-IFN-alfa-2a,RBV 48 Wk (Non Randomized)
Arm Type
Experimental
Arm Description
Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Only subjects with no RVR or no RVR assessment, and subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, who did not have eRVR or eRVR assessment, were included in this group, as planned.
Intervention Type
Drug
Intervention Name(s)
Telaprevir
Other Intervention Name(s)
INCIVEK, INCIVO, VX-950
Intervention Description
Tablet
Intervention Type
Drug
Intervention Name(s)
Pegylated Interferon Alfa-2a
Other Intervention Name(s)
Pegasys, Peg-IFN-Alfa-2a
Intervention Description
Subcutaneous Injection
Intervention Type
Drug
Intervention Name(s)
Ribavirin
Other Intervention Name(s)
Copegus, RBV
Intervention Description
Tablet
Primary Outcome Measure Information:
Title
Percentage of Subjects With Sustained Viral Response 12 Weeks After Last Planned Dose of Study Drug (SVR12)
Description
SVR12 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at 12 weeks after last planned 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) and the lower limit of detection was 10 IU/mL. This outcome was planned to be assessed only in "Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)" and "Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)" reporting groups.
Time Frame
12 weeks after last planned dose of study drug (up to Week 36)
Secondary Outcome Measure Information:
Title
Percentage of Subjects With Sustained Viral Response 4 Weeks After Last Planned Dose of Study Drug (SVR4)
Description
SVR4 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at 4 weeks after last planned dose of study treatment. 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) and the lower limit of detection was 10 IU/mL. This outcome was planned to be assessed only in "Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)" and "Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)" reporting groups.
Time Frame
4 weeks after last planned dose of study drug (up to Week 28)
Title
Percentage of Subjects With Sustained Viral Response 24 Weeks After Last Planned Dose of Study Drug (SVR24)
Description
SVR24 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at 24 weeks after last planned dose of study treatment. 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) and the lower limit of detection was 10 IU/mL. This outcome was planned to be assessed only in "Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)" and "Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)" reporting groups.
Time Frame
24 weeks after last planned dose of study drug (up to Week 48)
Title
Percentage of Subjects With Sustained Viral Response at Week 72 (SVR72)
Description
SVR72 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Week 72. 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) and the lower limit of detection was 10 IU/mL. This outcome was planned to be assessed only in "Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)" and "Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)" reporting groups.
Time Frame
Week 72
Title
Percentage of Subjects With Viral Relapse
Description
Viral relapse was defined as having detectable HCV RNA during antiviral follow-up in subjects who had HCV RNA less than (<) lower limit of quantification (LLOQ) at end of treatment. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The LLOQ was 25 IU/mL and the lower limit of detection was 10 IU/mL. This outcome was planned to be assessed only in "Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)" and "Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)" reporting groups.
Time Frame
After last dose of study drug up to 4 weeks (up to Week 28), 12 weeks (up to Week 36), 24 weeks (up to Week 48) antiviral follow-up
Title
Percentage of Subjects With On-Treatment Virologic Failure
Description
On-treatment virologic failure was defined as subjects who met futility (as per investigator discretion) or who completed the assigned treatment duration and had detectable HCV RNA at planned end of treatment (up to 48 weeks). This outcome was planned to be assessed in all reporting groups and results were to be reported for total arm as well.
Time Frame
Baseline up to Week 48
Title
Number of Subjects With Rapid Viral Response (RVR)
Description
The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. RVR was defined as undetectable HCV RNA 4 weeks after the start of study treatment. This outcome was planned to be assessed only in "Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)" and "Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)" reporting groups.
Time Frame
Week 4
Title
Number of Subjects With Extended Rapid Viral Response (eRVR)
Description
The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. eRVR was defined as undetectable HCV RNA at both 4 weeks and 12 weeks after the start of study treatment. This outcome was planned to be assessed only in "Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)" and "Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)" reporting groups.
Time Frame
Week 4 and Week 12
Title
Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description
AE: any adverse change from the subject's baseline (pre-treatment) condition, including any adverse experience, abnormal recording or clinical laboratory assessment value which occurs during the course of the study, whether it is considered related to the study drug or not. An adverse event includes any newly occurring event or previous condition that has increased in severity or frequency since the administration of study drug. SAE: 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. "Study drug" includes all investigational agents administered during the course of the study.
Time Frame
Baseline up to Week 48
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male and female subjects, 18 to 70 years of age, inclusive
Treatment-naive OR subjects (prior relapsers) may be included who did not achieve sustained viral response 24 weeks after last planned dose of study drug (SVR24) after at least 1 prior course of Peg-IFN/RBV therapy of standard duration and had a documented undetectable HCV RNA level at the planned end of treatment of at least 42-week duration
Subjects have IL28B CC genotype determined during screening
Subjects have genotype 1 chronic hepatitis C and laboratory evidence of HCV infection for at least 6 months, defined by (1) documented HCV serology test at least 6 months before the first screening visit demonstrating the presence of anti-HCV antibody, or (2) documented presence of HCV RNA by a sensitive and specific assay at least 6 months before the first screening visit, or (3) documented histologic evidence of chronic hepatitis C demonstrated by fibrosis on a standardized histologic grading system at least 6 months before the first screening visit. If only inflammation is present in the liver histologic report, then 6 months of laboratory evidence is required
Exclusion Criteria:
Subjects have received previous treatment with telaprevir or any other protease inhibitor(s) for chronic hepatitis C
Subjects who did not achieve SVR24 after at least 1 prior course of Peg-IFN/RBV therapy of standard duration and never achieved undetectable HCV RNA while on treatment
Subjects have evidence of hepatic decompensation
Subjects have evidence of cirrhosis
Subjects have diagnosed or suspected hepatocellular carcinoma
Subjects have 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. Steatosis is allowed if clinically asymptomatic
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Friedman, M.D.
Organizational Affiliation
Vertex Pharmaceuticals Incorporated
Official's Role
Study Director
Facility Information:
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
City
La Jolla
State/Province
California
ZIP/Postal Code
93037
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92105
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92154
Country
United States
Facility Name
California
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34209
Country
United States
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96817
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21202
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
City
Columbia
State/Province
Maryland
ZIP/Postal Code
21045
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
City
Brockton
State/Province
Massachusetts
ZIP/Postal Code
02302
Country
United States
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
City
Novi
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64131
Country
United States
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
City
Egg Harbor Township
State/Province
New Jersey
ZIP/Postal Code
08234
Country
United States
City
Vineland
State/Province
New Jersey
ZIP/Postal Code
08360
Country
United States
City
Flushing
State/Province
New York
ZIP/Postal Code
11355
Country
United States
City
Manhasset
State/Province
New York
ZIP/Postal Code
10030
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Pennsylvania
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Virginia
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53715
Country
United States
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
City
Linz
ZIP/Postal Code
4010
Country
Austria
City
Vienna
ZIP/Postal Code
1090
Country
Austria
City
Vienna
ZIP/Postal Code
1160
Country
Austria
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5M 1J7
Country
Canada
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2X8
Country
Canada
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T 1Z3
Country
Canada
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 3P4
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2N2
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
City
Berlin
ZIP/Postal Code
10969
Country
Germany
City
Dusseldorf
ZIP/Postal Code
40237
Country
Germany
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
City
Hamburg
ZIP/Postal Code
20099
Country
Germany
City
Hannover
ZIP/Postal Code
30625
Country
Germany
City
Koeln
ZIP/Postal Code
50937
Country
Germany
City
Leipzig
ZIP/Postal Code
4103
Country
Germany
City
Munich
ZIP/Postal Code
81377
Country
Germany
City
Haifa
ZIP/Postal Code
31096
Country
Israel
City
Haifa
ZIP/Postal Code
34362
Country
Israel
Facility Name
Israel
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
City
Nazareth
ZIP/Postal Code
16100
Country
Israel
City
Petah Tikva
ZIP/Postal Code
49100
Country
Israel
City
Tel Hashomer
ZIP/Postal Code
52621
Country
Israel
City
Bialystok
ZIP/Postal Code
16-540
Country
Poland
City
Czeladz
ZIP/Postal Code
41-250
Country
Poland
City
Myslowice
ZIP/Postal Code
41-400
Country
Poland
City
Wroclaw
ZIP/Postal Code
50-220
Country
Poland
12. IPD Sharing Statement
Learn more about this trial
Efficacy of a 12-Week Regimen of Telaprevir, Pegylated Interferon, and Ribavirin in Treatment-Naive and Prior Relapser Subjects With Interleukin28B (IL28B) CC Genotype
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