Safety and Efficacy Study of Peginterferon Lambda-1a vs. Peginterferon Alfa-2a, Plus Ribavirin in Subjects With Genotype 1 Hepatitis C (BASIS)

January 27, 2015 updated by: Bristol-Myers Squibb

A Double-Blinded, Randomized Control Study Evaluating the Efficacy and Safety of Peginterferon Lambda-1a Compared to Peginterferon Alfa-2a, Each in Combination With Ribavirin, in the Treatment of Naive Genotype 1 Chronic Hepatitis C Subjects

The purpose of this study is to determine if 48 weeks of therapy with Peginterferon Lambda plus Ribavirin is effective and safe for a treatment of chronic hepatitis C (CHC) compared to therapy with Peginterferon alfa-2a plus Ribavirin.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 3

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

  • Czech Republic
      • Hradec Kralove, Czech Republic, 500 05
        • Local Institution
      • Praha 4, Czech Republic, 140 00
        • Local Institution
      • Usti Nad Labem, Czech Republic, 400 01
        • Local Institution
  • Korea, Republic of
      • Chungcheongnam-do, Korea, Republic of, 330-930
        • Local Institution
      • Daegu, Korea, Republic of, 700-821
        • Local Institution
      • Gangwon-do, Korea, Republic of, 200-704
        • Local Institution
      • Gyeonggi-do, Korea, Republic of, 463-707
        • Local Institution
      • Gyeonggi-do, Korea, Republic of, 420-717
        • Local Institution
      • Gyeongsangnam-do, Korea, Republic of, 626-770
        • Local Institution
      • Incheon, Korea, Republic of, 403-720
        • Local Institution
      • Seoul, Korea, Republic of, 156-755
        • Local Institution
  • Mexico
      • Distrito Federal, Mexico, 03720
        • Local Institution
    • Distrito Federal
      • Mexico, Distrito Federal, Mexico, 07760
        • Local Institution
    • Estado De Mexico
      • Mexico City, Estado De Mexico, Mexico, 06700
        • Local Institution
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44650
        • Local Institution
      • Guadalajara, Jalisco, Mexico, 44500
        • Local Institution

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
  • Liver biopsy documenting no cirrhosis (within prior 3 years). Where approved for staging of liver disease, non-invasive imaging may be used to assess the extent of liver disease
  • Naïve to prior anti-HCV therapy

Exclusion Criteria:

  • Infected with HCV other than Genotype 1
  • Positive Hepatitis B Surface Antigen (HBsAg), or Human Immunodeficiency Virus (HIV)-1/HIV-2 antibody at screening
  • Evidence of liver disease other than HCV
  • Active substance abuse
  • Use of hematologic growth factors within 90 days prior to study randomization
  • Evidence of history of cirrhosis based on radiologic criteria or biopsy results and clinical criteria

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 Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Peginterferon Lambda-1a + Ribavirin
Peginterferon Lambda-1a 180 μg solution for subcutaneous (sc) injection once weekly and Ribavirin 1000 or 1200 mg based on weight tablet by mouth twice daily for 48 weeks
Drug: Ribavirin
Other Names:
  • Ribasphere
Biological: Peginterferon Lambda-1a
Other Names:
  • BMS-914143
Active Comparator: Peginterferon alfa-2a + Ribavirin
Peginterferon alfa-2a 180 μg solution for subcutaneous (sc) injection once weekly and Ribavirin 1000 or 1200 mg based on weight tablet by mouth twice daily for 48 weeks
Drug: Ribavirin
Other Names:
  • Ribasphere
Biological: Peginterferon alfa-2a
Other Names:
  • Pegasys

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of subjects who develop 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) in treatment-naive subjects
Time Frame: Up to 48 weeks of treatment
  • ANC = Absolute Neutrophil Count
  • Hb = Hemoglobin
Up to 48 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of subjects with Sustained Virologic Response at Post-Treatment Follow-up Week 24 (SVR24), defined as Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) < Lower Limit of Quantitation of Assay (LLOQ)
Time Frame: At Post-Treatment Follow-up Week 24
At Post-Treatment Follow-up Week 24
Proportion of subjects with Rapid Virologic Response (RVR) (HCV RNA not detected)
Time Frame: On treatment Week 4 (of an up to 48-week treatment period)
On treatment Week 4 (of an up to 48-week treatment period)
Proportion of subjects with on-treatment Serious Adverse Events (SAEs) through end of treatment
Time Frame: Up to 48 weeks of treatment
Up to 48 weeks of treatment
Proportion of subjects with dose reductions through end of treatment
Time Frame: Up to 48 weeks of treatment
Up to 48 weeks of treatment
Proportion of subjects who discontinue due to Adverse Events (AEs) through end of treatment
Time Frame: Up to 48 weeks of treatment
Up to 48 weeks of treatment
Proportion of subjects with on-treatment Interferon (IFN)-associated symptoms as determined by adverse event reporting
Time Frame: Up to 48 weeks of treatment

On-treatment IFN-associated symptoms are:

  • Flu-like symptoms (as defined by pyrexia or chills or pain)
  • Musculoskeletal symptoms (as defined by arthralgia or myalgia or back pain)
  • Neurological symptoms (headache or dizziness)
  • Constitutional symptoms (fatigue or asthenia)
  • Psychiatric symptoms (depression or irritability or insomnia)
Up to 48 weeks of treatment

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, 2013

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

December 19, 2012

First Submitted That Met QC Criteria

December 20, 2012

First Posted (Estimate)

December 21, 2012

Study Record Updates

Last Update Posted (Estimate)

January 28, 2015

Last Update Submitted That Met QC Criteria

January 27, 2015

Last Verified

December 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AI452-033
  • 2012-003508-11 (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 Virus (HCV)

Clinical Trials on Ribavirin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Jordan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe