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

Primary Purpose

Hepatitis C Virus (HCV)

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Peginterferon Lambda-1a
Ribavirin
Peginterferon alfa-2a
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C Virus (HCV)

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Peginterferon Lambda-1a + Ribavirin

Peginterferon alfa-2a + Ribavirin

Arm Description

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

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

Outcomes

Primary Outcome Measures

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
ANC = Absolute Neutrophil Count Hb = Hemoglobin

Secondary Outcome Measures

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)
Proportion of subjects with Rapid Virologic Response (RVR) (HCV RNA not detected)
Proportion of subjects with on-treatment Serious Adverse Events (SAEs) through end of treatment
Proportion of subjects with dose reductions through end of treatment
Proportion of subjects who discontinue due to Adverse Events (AEs) through end of treatment
Proportion of subjects with on-treatment Interferon (IFN)-associated symptoms as determined by adverse event reporting
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)

Full Information

First Posted
December 19, 2012
Last Updated
January 27, 2015
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT01754974
Brief Title
Safety and Efficacy Study of Peginterferon Lambda-1a vs. Peginterferon Alfa-2a, Plus Ribavirin in Subjects With Genotype 1 Hepatitis C
Acronym
BASIS
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C Virus (HCV)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Peginterferon Lambda-1a + Ribavirin
Arm Type
Experimental
Arm Description
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
Arm Title
Peginterferon alfa-2a + Ribavirin
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Biological
Intervention Name(s)
Peginterferon Lambda-1a
Other Intervention Name(s)
BMS-914143
Intervention Type
Drug
Intervention Name(s)
Ribavirin
Other Intervention Name(s)
Ribasphere
Intervention Type
Biological
Intervention Name(s)
Peginterferon alfa-2a
Other Intervention Name(s)
Pegasys
Primary Outcome Measure Information:
Title
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
Description
ANC = Absolute Neutrophil Count Hb = Hemoglobin
Time Frame
Up to 48 weeks of treatment
Secondary Outcome Measure Information:
Title
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
Title
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)
Title
Proportion of subjects with on-treatment Serious Adverse Events (SAEs) through end of treatment
Time Frame
Up to 48 weeks of treatment
Title
Proportion of subjects with dose reductions through end of treatment
Time Frame
Up to 48 weeks of treatment
Title
Proportion of subjects who discontinue due to Adverse Events (AEs) through end of treatment
Time Frame
Up to 48 weeks of treatment
Title
Proportion of subjects with on-treatment Interferon (IFN)-associated symptoms as determined by adverse event reporting
Description
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)
Time Frame
Up to 48 weeks of treatment

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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czech Republic
Facility Name
Local Institution
City
Praha 4
ZIP/Postal Code
140 00
Country
Czech Republic
Facility Name
Local Institution
City
Usti Nad Labem
ZIP/Postal Code
400 01
Country
Czech Republic
Facility Name
Local Institution
City
Chungcheongnam-do
ZIP/Postal Code
330-930
Country
Korea, Republic of
Facility Name
Local Institution
City
Daegu
ZIP/Postal Code
700-821
Country
Korea, Republic of
Facility Name
Local Institution
City
Gangwon-do
ZIP/Postal Code
200-704
Country
Korea, Republic of
Facility Name
Local Institution
City
Gyeonggi-do
ZIP/Postal Code
420-717
Country
Korea, Republic of
Facility Name
Local Institution
City
Gyeonggi-do
ZIP/Postal Code
463-707
Country
Korea, Republic of
Facility Name
Local Institution
City
Gyeongsangnam-do
ZIP/Postal Code
626-770
Country
Korea, Republic of
Facility Name
Local Institution
City
Incheon
ZIP/Postal Code
403-720
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
156-755
Country
Korea, Republic of
Facility Name
Local Institution
City
Mexico
State/Province
Distrito Federal
ZIP/Postal Code
07760
Country
Mexico
Facility Name
Local Institution
City
Mexico City
State/Province
Estado De Mexico
ZIP/Postal Code
06700
Country
Mexico
Facility Name
Local Institution
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44500
Country
Mexico
Facility Name
Local Institution
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44650
Country
Mexico
Facility Name
Local Institution
City
Distrito Federal
ZIP/Postal Code
03720
Country
Mexico

12. IPD Sharing Statement

Links:
URL
http://www.bms.com/studyconnect/Pages/home.aspx
Description
BMS clinical trial educational resource

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

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