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

Substudy C: The purpose of this substudy is to determine whether Lambda combined with Ribavirin and Daclatasvir for 12 weeks is efficacious in treatment naïve subjects with genotype 1b chronic HCV infection

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

  • United States
    • Texas
      • San Antonio, Texas, United States, 78215
        • Alamo Medical Research

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

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Substudy C: Pegylated Interferon Lambda+Ribasphere+Daclatasvir

Pegylated Interferon Lambda 180 μg Solution, Subcutaneous Once weekly for 12 weeks;

Ribasphere 1000 mg for subjects weighing < 75 kg and 1200 mg for subjects weighing ≥ 75 kg oral tablets per day [subjects should take either 400 mg for subjects < 75 kg or 600 mg ≥ 75 kg in the morning with food and 600 mg in the evening with food] for 12 weeks;

Daclatasvir 60 mg oral tablet Once daily for 12 weeks
Drug: Daclatasvir
Other Names:
  • BMS-790052
Biological: Pegylated Interferon Lambda
Other Names:
  • BMS-914143
Drug: Ribasphere
Other Names:
  • Ribavirin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Antiviral activity, as determined by the proportion of non-cirrhotic HCV GT-1b subjects with 12-week sustained virologic response (SVR12), defined as HCV RNA < LLOQ target detected or not detected
Time Frame: Post-treatment Week 12
HCV = Hepatitis C virus; GT = Geno Type; RNA = Ribonucleic acid; LLOQ = Lower limit of quantitation
Post-treatment Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of non-cirrhotic HCV GT-1b subjects with eRVR, defined as HCV RNA < LLOQ target not detected
Time Frame: At Week 4 and Week 12
eRVR = Extended rapid virologic response
At Week 4 and Week 12
Proportion of non-cirrhotic HCV GT-1b subjects with treatment-emergent cytopenic abnormalities (anemia as defined by Hb < 10 g/dL, and/or neutropenia as defined by ANC < 750 mm3, and/or thrombocytopenia as defined by platelets < 50,000 mm3) on treatment
Time Frame: On-treatment Weeks 1, 2, 4, 8, and 12
Hb = Hemoglobin; ANC = Absolute neutrophil count
On-treatment Weeks 1, 2, 4, 8, and 12
Proportion of non-cirrhotic HCV GT-1b subjects with on-treatment (maximum of 12 weeks) interferon-associated flu-like symptoms (pyrexia or chills or pain)
Time Frame: On-treatment Weeks 1, 2, 4, 8, and 12
On-treatment Weeks 1, 2, 4, 8, and 12
Proportion of non-cirrhotic HCV GT-1b subjects with on-treatment (maximum of 12 weeks) interferon-associated musculoskeletal symptoms (arthralgia or myalgia or back pain)
Time Frame: On-treatment Weeks 1, 2, 4, 8, and 12
On-treatment Weeks 1, 2, 4, 8, and 12
Proportion of non-cirrhotic HCV GT-1b subjects with SVR24, defined as HCV RNA < LLOQ target detected or not detected
Time Frame: Post-treatment follow-up Week 24
Post-treatment follow-up Week 24
Frequency of deaths among non-cirrhotic HCV GT-1b subjects through the end of follow-up (maximum of 60 weeks)
Time Frame: On-treatment Weeks 1, 2, 4, 8, and 12 and post-treatment weeks 4, 12, 24, 36 and 48
On-treatment Weeks 1, 2, 4, 8, and 12 and post-treatment weeks 4, 12, 24, 36 and 48
Frequency of Serious adverse events (SAEs) among non-cirrhotic HCV GT-1b subjects through the end of follow-up (maximum of 60 weeks)
Time Frame: On-treatment Weeks 1, 2, 4, 8, and 12 and post-treatment weeks 4, 12, 24, 36 and 48
On-treatment Weeks 1, 2, 4, 8, and 12 and post-treatment weeks 4, 12, 24, 36 and 48
Frequency of drug related Adverse events (AEs) among non-cirrhotic HCV GT-1b subjects through the end of treatment (maximum of 12 weeks)
Time Frame: On-treatment Weeks 1, 2, 4, 8, and 12
On-treatment Weeks 1, 2, 4, 8, and 12
Frequency of dose reductions and discontinuations due to AEs among non-cirrhotic HCV GT-1b subjects through the end of treatment (maximum of 12 weeks)
Time Frame: On-treatment Weeks 1, 2, 4, 8, and 12
On-treatment Weeks 1, 2, 4, 8, and 12
Frequency of treatment emergent laboratory abnormalities among non-cirrhotic HCV GT-1b subjects through the end of treatment (maximum of 12 weeks)
Time Frame: On-treatment Weeks 1, 2, 4, 8, and 12
On-treatment Weeks 1, 2, 4, 8, and 12
Proportion of non-cirrhotic HCV GT-1b subjects with interferon-associated constitutional symptoms (fatigue or asthenia) through the end of treatment (maximum of 12 weeks)
Time Frame: On-treatment Weeks 1, 2, 4, 8, and 12
On-treatment Weeks 1, 2, 4, 8, and 12
Proportion of non-cirrhotic HCV GT-1b subjects with interferon-associated neurologic symptoms (headache or dizziness) through the end of treatment (maximum of 12 weeks)
Time Frame: On-treatment Weeks 1, 2, 4, 8, and 12
On-treatment Weeks 1, 2, 4, 8, and 12
Proportion of non-cirrhotic HCV GT-1b subjects with psychiatric symptoms (depression or irritability or insomnia) through the end of treatment (maximum of 12 weeks)
Time Frame: On-treatment Weeks 1, 2, 4, 8, and 12
On-treatment Weeks 1, 2, 4, 8, and 12

Collaborators and Investigators

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

Sponsor

Bristol-Myers Squibb

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, 2013

Primary Completion (ACTUAL)

April 1, 2014

Study Completion (ACTUAL)

September 1, 2014

Study Registration Dates

First Submitted

February 20, 2013

First Submitted That Met QC Criteria

February 20, 2013

First Posted (ESTIMATE)

February 21, 2013

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 (Substudy Part C)
  • 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.

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