Safety Study of Pegylated Interferon Lambda Plus Single or 2 Direct Antiviral Agents With Ribavirin (D-LITE)

September 23, 2015 updated by: Bristol-Myers Squibb

A Phase 2B, Randomized Study to Evaluate the Safety and Efficacy of Pegylated Interferon Lambda (BMS-914143) Administered With Ribavirin Plus a Single Direct Antiviral Agent (BMS-790052 or BMS-650032) Versus Pegasys Administered With Ribavirin (Part A) and of Pegylated Interferon Lambda (BMS-914143) Administered With or Without Ribavirin Plus 2 Direct Antiviral Agents (BMS-790052 and BMS-650032) (Part B) in Chronic Hepatitis C Genotype-1 Treatment naïve Subjects

The purpose of this study is to determine if combination therapy with Pegylated Interferon Lambda (BMS-914143) plus Ribavirin (RBV) with a single direct antiviral agent (BMS-790052 or BMS-650032) for 24 weeks is effective and safe for treatment of Chronic Hepatitis C (CHC) compared to current standard therapy with Pegylated Interferon Alpha-2a plus RBV for 48 weeks.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study Classification: Pharmacokinetics/ Pharmacodynamics

Study Type

Interventional

Enrollment (Actual)

165

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Local Institution
    • Victoria
      • Clayton Vic, Victoria, Australia, 3168
        • Local Institution
      • Heidelberg, Victoria, Australia, 3084
        • Local Institution
    • Western Australia
      • Perth, Western Australia, Australia, 6001
        • Local Institution
  • France
      • Clichy Cedex, France, 92118
        • Local Institution
      • Creteil, France, 94000
        • Local Institution
      • Montpellier Cedex 5, France, 34295
        • Local Institution
      • Nice Cedex 03, France, 06202
        • Local Institution
      • Paris Cedex 12, France, 75571
        • Local Institution
      • Paris Cedex 14, France, 75679
        • Local Institution
  • Germany
      • Essen, Germany, 45122
        • Local Institution
      • Frankfurt, Germany, 60590
        • Local Institution
      • Hamburg, Germany, 20246
        • Local Institution
  • Italy
      • Pisa, Italy, 56124
        • Local Institution
      • Roma, Italy, 00161
        • Local Institution
  • Japan
    • Hiroshima
      • Hiroshima-shi, Hiroshima, Japan, 7348511
        • Local Institution
    • Hokkaido
      • Sapporo-shi, Hokkaido, Japan, 060-0033
        • Local Institution
    • Kanagawa
      • Kawasaki-shi, Kanagawa, Japan, 2138587
        • Local Institution
    • Osaka
      • Osaka-shi, Osaka, Japan, 5458586
        • Local Institution
    • Saitama
      • Iruma-gun, Saitama, Japan, 3500495
        • Local Institution
    • Tokyo
      • Minato-ku, Tokyo, Japan, 105-0001
        • Local Institution
      • Musashino-shi, Tokyo, Japan, 180-0023
        • Local Institution
  • New Zealand
      • Christchurch, New Zealand, 8011
        • Local Institution
    • Auckland
      • Grafton, Auckland, New Zealand, 1010
        • Local Institution
  • Puerto Rico
      • San Juan, Puerto Rico, 00927
        • Fundacion de Investigacion de Diego
  • Spain
      • Barcelona, Spain, 08003
        • Local Institution
      • Valencia, Spain, 46010
        • Local Institution
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Mayo Clinic Hospital
    • California
      • Palm Springs, California, United States, 92262
        • Desert Medical Group Inc.
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Denver and Hospital
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale University School of Medicine
    • Maryland
      • Lutherville, Maryland, United States, 21093
        • Johns Hopkins University
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System
    • New York
      • Manhasset, New York, United States, 11030
        • Bristol-Myers Squibb/David E. Bernstein, Md
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Carolinas Medical Center
      • Statesville, North Carolina, United States, 28677
        • Carolinas Center For Liver Disease
    • Texas
      • Houston, Texas, United States, 77030
        • St. Luke'S Episcopal Hospital - Baylor College Of Medicine
      • San Antonio, Texas, United States, 78215
        • Texas Liver Institute
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Metropolitan Research
    • Washington
      • Seattle, Washington, United States, 98101
        • Virginia Mason Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

  • Chronic Hepatitis C, Genotype 1
  • HCV RNA >100,000 IU/mL at screening;
  • Seronegative for Human immunodeficiency virus (HIV) and Hepatitis B surface antigen (HBsAg);
  • Liver biopsy within prior 2 years; subjects with compensated cirrhosis can enroll and will be capped at approximately 10%

Exclusion Criteria:

  • Any evidence of liver disease other than HCV;
  • Co-infection with HIV;
  • Diagnosed or suspected hepatocellular carcinoma;
  • Medical history or laboratory value abnormalities that would prohibit the use of Pegylated Interferon Alpha-2a or Ribavirin

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: A1: pegIFNλ+BMS-790052+Placebo for BMS-650032+Ribavirin
Part A
Biological: Pegylated Interferon Lambda (pegIFNλ)
Solution, Subcutaneous, 180 μg/mL, Once weekly, 24 or 48 weeks depending on response
Other Names:
  • BMS-914143
Drug: BMS-790052 (NS5A Inhibitor)
Tablets, Oral, 60 mg, Once daily, 24 weeks
Other Names:
  • BMS-790052
Drug: Ribavirin (RBV)
Tablets, Oral, 1000 or 1200 mg based on weight, Twice daily, 48 weeks
Other Names:
  • Ribasphere
Biological: Pegylated Interferon Lambda (pegIFNλ)
Solution, Subcutaneous, 180 μg/mL, Once weekly, 24 weeks
Other Names:
  • BMS-914143
Drug: Ribavirin (RBV)
Tablets, Oral, 1000 or 1200 mg based on weight, Twice daily, 24 weeks
Other Names:
  • Ribasphere
Biological: Pegylated Interferon Lambda (pegIFNλ)
Solution, Subcutaneous, 180 μg/mL, Once weekly, 16 weeks
Other Names:
  • BMS-914143
Drug: Ribavirin (RBV)
Tablets, Oral, 1000 or 1200 mg based on weight, Twice daily, 16 weeks
Other Names:
  • Ribasphere
Drug: BMS-790052 (NS5A Inhibitor)
Tablets, Oral, 60 mg, Once daily, 16 weeks
Other Names:
  • BMS-790052
Drug: Placebo (PBO) for BMS-650032 (Placebo for NS3 Protease Inhibitor)
Tablets, Oral, 0 mg, Twice daily, 24 weeks
Other Names:
  • Placebo for BMS-650032
EXPERIMENTAL: A2: pegIFNλ+BMS-650032+Placebo for BMS-790052+Ribavirin
Part A
Biological: Pegylated Interferon Lambda (pegIFNλ)
Solution, Subcutaneous, 180 μg/mL, Once weekly, 24 or 48 weeks depending on response
Other Names:
  • BMS-914143
Drug: Ribavirin (RBV)
Tablets, Oral, 1000 or 1200 mg based on weight, Twice daily, 48 weeks
Other Names:
  • Ribasphere
Biological: Pegylated Interferon Lambda (pegIFNλ)
Solution, Subcutaneous, 180 μg/mL, Once weekly, 24 weeks
Other Names:
  • BMS-914143
Drug: Ribavirin (RBV)
Tablets, Oral, 1000 or 1200 mg based on weight, Twice daily, 24 weeks
Other Names:
  • Ribasphere
Biological: Pegylated Interferon Lambda (pegIFNλ)
Solution, Subcutaneous, 180 μg/mL, Once weekly, 16 weeks
Other Names:
  • BMS-914143
Drug: Ribavirin (RBV)
Tablets, Oral, 1000 or 1200 mg based on weight, Twice daily, 16 weeks
Other Names:
  • Ribasphere
Drug: BMS-650032 (NS3 Protease Inhibitor)
Tablets, Oral, 200 mg, Twice daily, 24 weeks
Other Names:
  • BMS-650032
Drug: BMS-650032 (NS3 Protease Inhibitor)
Tablets, Oral, 200 mg, Twice daily, 16 weeks
Other Names:
  • BMS-650032
Drug: Placebo (PBO) for BMS-790052 (Placebo for NS5A Inhibitor)
Tablets, Oral, 0 mg, Once daily, 24 weeks
Other Names:
  • Placebo for BMS-790052
ACTIVE_COMPARATOR: A3: pegIFNα-2a+PBO for BMS-790052+PBO for BMS-650032+RBV
Part A
Drug: Ribavirin (RBV)
Tablets, Oral, 1000 or 1200 mg based on weight, Twice daily, 48 weeks
Other Names:
  • Ribasphere
Drug: Ribavirin (RBV)
Tablets, Oral, 1000 or 1200 mg based on weight, Twice daily, 24 weeks
Other Names:
  • Ribasphere
Drug: Ribavirin (RBV)
Tablets, Oral, 1000 or 1200 mg based on weight, Twice daily, 16 weeks
Other Names:
  • Ribasphere
Drug: Placebo (PBO) for BMS-650032 (Placebo for NS3 Protease Inhibitor)
Tablets, Oral, 0 mg, Twice daily, 24 weeks
Other Names:
  • Placebo for BMS-650032
Drug: Placebo (PBO) for BMS-790052 (Placebo for NS5A Inhibitor)
Tablets, Oral, 0 mg, Once daily, 24 weeks
Other Names:
  • Placebo for BMS-790052
Biological: Pegylated Interferon Alfa-2a (pegIFNα-2a)
Solution, Subcutaneous, 180 μg/mL, Once weekly, 48 weeks
Other Names:
  • Pegasys®
EXPERIMENTAL: A4: pegIFNλ+BMS-790052+BMS-650032+Ribavirin (24 weeks)
Part B
Biological: Pegylated Interferon Lambda (pegIFNλ)
Solution, Subcutaneous, 180 μg/mL, Once weekly, 24 or 48 weeks depending on response
Other Names:
  • BMS-914143
Drug: BMS-790052 (NS5A Inhibitor)
Tablets, Oral, 60 mg, Once daily, 24 weeks
Other Names:
  • BMS-790052
Drug: Ribavirin (RBV)
Tablets, Oral, 1000 or 1200 mg based on weight, Twice daily, 48 weeks
Other Names:
  • Ribasphere
Biological: Pegylated Interferon Lambda (pegIFNλ)
Solution, Subcutaneous, 180 μg/mL, Once weekly, 24 weeks
Other Names:
  • BMS-914143
Drug: Ribavirin (RBV)
Tablets, Oral, 1000 or 1200 mg based on weight, Twice daily, 24 weeks
Other Names:
  • Ribasphere
Biological: Pegylated Interferon Lambda (pegIFNλ)
Solution, Subcutaneous, 180 μg/mL, Once weekly, 16 weeks
Other Names:
  • BMS-914143
Drug: Ribavirin (RBV)
Tablets, Oral, 1000 or 1200 mg based on weight, Twice daily, 16 weeks
Other Names:
  • Ribasphere
Drug: BMS-790052 (NS5A Inhibitor)
Tablets, Oral, 60 mg, Once daily, 16 weeks
Other Names:
  • BMS-790052
Drug: BMS-650032 (NS3 Protease Inhibitor)
Tablets, Oral, 200 mg, Twice daily, 24 weeks
Other Names:
  • BMS-650032
Drug: BMS-650032 (NS3 Protease Inhibitor)
Tablets, Oral, 200 mg, Twice daily, 16 weeks
Other Names:
  • BMS-650032
EXPERIMENTAL: A5: pegIFNλ+BMS-790052+BMS-650032+Ribavirin (16 weeks)
Part B
Biological: Pegylated Interferon Lambda (pegIFNλ)
Solution, Subcutaneous, 180 μg/mL, Once weekly, 24 or 48 weeks depending on response
Other Names:
  • BMS-914143
Drug: BMS-790052 (NS5A Inhibitor)
Tablets, Oral, 60 mg, Once daily, 24 weeks
Other Names:
  • BMS-790052
Drug: Ribavirin (RBV)
Tablets, Oral, 1000 or 1200 mg based on weight, Twice daily, 48 weeks
Other Names:
  • Ribasphere
Biological: Pegylated Interferon Lambda (pegIFNλ)
Solution, Subcutaneous, 180 μg/mL, Once weekly, 24 weeks
Other Names:
  • BMS-914143
Drug: Ribavirin (RBV)
Tablets, Oral, 1000 or 1200 mg based on weight, Twice daily, 24 weeks
Other Names:
  • Ribasphere
Biological: Pegylated Interferon Lambda (pegIFNλ)
Solution, Subcutaneous, 180 μg/mL, Once weekly, 16 weeks
Other Names:
  • BMS-914143
Drug: Ribavirin (RBV)
Tablets, Oral, 1000 or 1200 mg based on weight, Twice daily, 16 weeks
Other Names:
  • Ribasphere
Drug: BMS-790052 (NS5A Inhibitor)
Tablets, Oral, 60 mg, Once daily, 16 weeks
Other Names:
  • BMS-790052
Drug: BMS-650032 (NS3 Protease Inhibitor)
Tablets, Oral, 200 mg, Twice daily, 24 weeks
Other Names:
  • BMS-650032
Drug: BMS-650032 (NS3 Protease Inhibitor)
Tablets, Oral, 200 mg, Twice daily, 16 weeks
Other Names:
  • BMS-650032
EXPERIMENTAL: A6: pegIFNλ+BMS-790052+BMS-650032+Placebo for RBV (24 weeks)
Part B
Biological: Pegylated Interferon Lambda (pegIFNλ)
Solution, Subcutaneous, 180 μg/mL, Once weekly, 24 or 48 weeks depending on response
Other Names:
  • BMS-914143
Drug: BMS-790052 (NS5A Inhibitor)
Tablets, Oral, 60 mg, Once daily, 24 weeks
Other Names:
  • BMS-790052
Biological: Pegylated Interferon Lambda (pegIFNλ)
Solution, Subcutaneous, 180 μg/mL, Once weekly, 24 weeks
Other Names:
  • BMS-914143
Biological: Pegylated Interferon Lambda (pegIFNλ)
Solution, Subcutaneous, 180 μg/mL, Once weekly, 16 weeks
Other Names:
  • BMS-914143
Drug: BMS-790052 (NS5A Inhibitor)
Tablets, Oral, 60 mg, Once daily, 16 weeks
Other Names:
  • BMS-790052
Drug: BMS-650032 (NS3 Protease Inhibitor)
Tablets, Oral, 200 mg, Twice daily, 24 weeks
Other Names:
  • BMS-650032
Drug: BMS-650032 (NS3 Protease Inhibitor)
Tablets, Oral, 200 mg, Twice daily, 16 weeks
Other Names:
  • BMS-650032
Drug: Placebo for Ribavirin (RBV)
Tablets, Oral, 0 mg, Twice daily, 24 weeks
Other Names:
  • Placebo for Ribasphere
Drug: Placebo for Ribavirin (RBV)
Tablets, Oral, 0 mg, Twice daily, 16 weeks
Other Names:
  • Placebo for Ribasphere
EXPERIMENTAL: A7: pegIFNλ+BMS-790052+BMS-650032+Placebo for RBV (16 weeks)
Part B
Biological: Pegylated Interferon Lambda (pegIFNλ)
Solution, Subcutaneous, 180 μg/mL, Once weekly, 24 or 48 weeks depending on response
Other Names:
  • BMS-914143
Drug: BMS-790052 (NS5A Inhibitor)
Tablets, Oral, 60 mg, Once daily, 24 weeks
Other Names:
  • BMS-790052
Biological: Pegylated Interferon Lambda (pegIFNλ)
Solution, Subcutaneous, 180 μg/mL, Once weekly, 24 weeks
Other Names:
  • BMS-914143
Biological: Pegylated Interferon Lambda (pegIFNλ)
Solution, Subcutaneous, 180 μg/mL, Once weekly, 16 weeks
Other Names:
  • BMS-914143
Drug: BMS-790052 (NS5A Inhibitor)
Tablets, Oral, 60 mg, Once daily, 16 weeks
Other Names:
  • BMS-790052
Drug: BMS-650032 (NS3 Protease Inhibitor)
Tablets, Oral, 200 mg, Twice daily, 24 weeks
Other Names:
  • BMS-650032
Drug: BMS-650032 (NS3 Protease Inhibitor)
Tablets, Oral, 200 mg, Twice daily, 16 weeks
Other Names:
  • BMS-650032
Drug: Placebo for Ribavirin (RBV)
Tablets, Oral, 0 mg, Twice daily, 24 weeks
Other Names:
  • Placebo for Ribasphere
Drug: Placebo for Ribavirin (RBV)
Tablets, Oral, 0 mg, Twice daily, 16 weeks
Other Names:
  • Placebo for Ribasphere

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety and tolerability (as measured by the frequency of serious adverse events (SAEs), dose reductions and discontinuations due to adverse events (AEs)
Time Frame: Up to end of treatment ( maximum of 48 weeks) plus 30 days
Up to end of treatment ( maximum of 48 weeks) plus 30 days
Antiviral activity as determined by the proportion of Hepatitis C virus (HCV) genotype 1 subjects with 24-week sustained virologic response (SVR24)
Time Frame: At end of treatment (maximum of 48 weeks)
At end of treatment (maximum of 48 weeks)
Antiviral activity as determined by the proportion of Hepatitis C virus (HCV) genotype 1 subjects with 24-week sustained virologic response (SVR24)
Time Frame: Post-treatment Week 24
Post-treatment Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of HCV genotype 1 subjects with Protocol definition of virologic response (PDR) for Part A and Part B
Time Frame: Weeks 4, Weeks 12 and post-treatment Weeks 24
  • Part A PDR is defined as HCV RNA at Week 4 < LLOQ and Week 12 undetectable
  • Part B PDR is defined as HCV RNA at Week 2 ≥ 2 log10 decrease (or < Lower limit of quantitation (LLOQ) if baseline HCV RNA < 2400 IU/mL), Week 4 < LLOQ and Week 12 undetectable
Weeks 4, Weeks 12 and post-treatment Weeks 24
Proportion of subjects with either a 2-log or greater decrease in Hepatitis C virus (HCV) Ribonucleic acid (RNA) levels from baseline or undetectable levels of HCV RNA
Time Frame: Weeks 2, Weeks 4 and Weeks 12
Weeks 2, Weeks 4 and Weeks 12
Proportion of subjects with viral breakthrough, defined as confirmed > 1 log10 increase in HCV RNA over nadir or confirmed HCV RNA ≥ Lower limit of quantitation (LLOQ) after confirmed undetectable HCV RNA while on treatment
Time Frame: Post-treatment Week 48
Post-treatment Week 48
Proportion of subjects with undetectable HCV RNA at the end of treatment that develop detectable levels of HCV RNA in the post-treatment follow-up period
Time Frame: Post-treatment Week 48
Post-treatment Week 48
Serum HCV Ribonucleic acid (RNA) levels over time
Time Frame: Days 1, 3, Weeks 1, 2, 4, 6, 8, 12, 16, 20, and end of treatment (Week 16, 24 or 48 depending on treatment assignment)
Days 1, 3, Weeks 1, 2, 4, 6, 8, 12, 16, 20, and end of treatment (Week 16, 24 or 48 depending on treatment assignment)
Proportion of subjects with undetectable HCV RNA over time
Time Frame: Days 1, 3, Weeks 1, 2, 4, 6, 8, 12, 16, 20, and end of treatment (Week 16, 24 or 48 depending on treatment assignment)
Days 1, 3, Weeks 1, 2, 4, 6, 8, 12, 16, 20, and end of treatment (Week 16, 24 or 48 depending on treatment assignment)
Time to viral clearance, defined as an absence of detectable HCV RNA
Time Frame: Day 1, 3, Week 1, 2, 4, 6, 8, 12, 24, 36, end of treatment (Week 48), Post-Treatment at Week 4, 12, 24, 36, 48, and 56
Day 1, 3, Week 1, 2, 4, 6, 8, 12, 24, 36, end of treatment (Week 48), Post-Treatment at Week 4, 12, 24, 36, 48, and 56
Serum levels of pegIFNλ and pegIFNα-2a and plasma levels of BMS-790052 and BMS-650032: In PK sub-study group Maximum observed serum/plasma concentration (Cmax)
Time Frame: Cmax will be determined at Dose 5 (Study Visit Week 4: 0 - 12 h for BMS-650032, 0 - 24 h for BMS-790052, and 0 - 168 h for pegIFNλ and pegIFNα-2a)
Cmax will be determined at Dose 5 (Study Visit Week 4: 0 - 12 h for BMS-650032, 0 - 24 h for BMS-790052, and 0 - 168 h for pegIFNλ and pegIFNα-2a)
Serum levels of pegIFNλ and pegIFNα-2a and plasma levels of BMS-790052 and BMS-650032: In PK sub-study group Time to maximum concentration (Tmax)
Time Frame: Tmax will be determined at Dose 5 (Study Visit Week 4: 0 - 12 h for BMS-650032, 0 - 24 h for BMS-790052, and 0 - 168 h for pegIFNλ and pegIFNα-2a)
Tmax will be determined at Dose 5 (Study Visit Week 4: 0 - 12 h for BMS-650032, 0 - 24 h for BMS-790052, and 0 - 168 h for pegIFNλ and pegIFNα-2a)
Serum levels of pegIFNλ and pegIFNα-2a and plasma levels of BMS-790052 and BMS-650032: In PK sub-study group Minimal observed serum/plasma concentration (Cmin)
Time Frame: Cmin will be determined at Dose 5 (Study Visit Week 4: 0 - 12 h for BMS-650032, 0 - 24 h for BMS-790052, and 0 - 168 h for pegIFNλ and pegIFNα-2a)
Cmin will be determined at Dose 5 (Study Visit Week 4: 0 - 12 h for BMS-650032, 0 - 24 h for BMS-790052, and 0 - 168 h for pegIFNλ and pegIFNα-2a)
Serum levels of pegIFNλ and pegIFNα-2a and plasma levels of BMS-790052 and BMS-650032: In PK sub-study group Area under the serum/plasma concentration-time curve during one dose interval AUC(TAU)
Time Frame: AUC(TAU) will be determined at Dose 5 (Study Visit Week 4: 0 - 12 h for BMS-650032, 0 - 24 h for BMS-790052, and 0 - 168 h for pegIFNλ and pegIFNα-2a)
AUC(TAU) will be determined at Dose 5 (Study Visit Week 4: 0 - 12 h for BMS-650032, 0 - 24 h for BMS-790052, and 0 - 168 h for pegIFNλ and pegIFNα-2a)
Serum levels of pegIFNλ and pegIFNα-2a and plasma levels of BMS-790052 and BMS-650032: In all subjects, trough concentrations will be assessed (Ctrough)
Time Frame: Troughs at baseline (week 0), weeks 2, 4, 8, 12, 16, and 24
Troughs at baseline (week 0), weeks 2, 4, 8, 12, 16, and 24
Proportion of subjects with 12-week sustained virologic response (SVR12), defined as undetectable HCV RNA
Time Frame: At end of treatment (maximum of 48 weeks) and follow-up Week 12
At end of treatment (maximum of 48 weeks) and follow-up Week 12
Proportion of subjects with 4-week sustained virologic response (SVR4), defined as undetectable HCV RNA
Time Frame: At end of treatment (maximum of 48 weeks) and follow-up Week 4
At end of treatment (maximum of 48 weeks) and follow-up Week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (ACTUAL)

July 1, 2014

Study Completion (ACTUAL)

September 1, 2014

Study Registration Dates

First Submitted

March 4, 2011

First Submitted That Met QC Criteria

March 4, 2011

First Posted (ESTIMATE)

March 7, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

October 9, 2015

Last Update Submitted That Met QC Criteria

September 23, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AI452-008
  • 2010-022568-11 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hepatitis C

Clinical Trials on Pegylated Interferon Lambda (pegIFNλ)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Argentina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe