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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)

This study is not yet open for participant recruitment.
Verified April 2013 by Bristol-Myers Squibb
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01754974
First received: December 19, 2012
Last updated: April 10, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Hepatitis C Virus (HCV)
 Biological: Peginterferon Lambda-1a
Drug: Ribavirin
Biological: Peginterferon alfa-2a
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

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 [ Time Frame: Up to 48 weeks of treatment ] [ Designated as safety issue: Yes ]
    • 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) [ Time Frame: At Post-Treatment Follow-up Week 24 ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • Proportion of subjects with on-treatment Serious Adverse Events (SAEs) through end of treatment [ Time Frame: Up to 48 weeks of treatment ] [ Designated as safety issue: Yes ]
  • Proportion of subjects with dose reductions through end of treatment [ Time Frame: Up to 48 weeks of treatment ] [ Designated as safety issue: Yes ]
  • Proportion of subjects who discontinue due to Adverse Events (AEs) through end of treatment [ Time Frame: Up to 48 weeks of treatment ] [ Designated as safety issue: Yes ]
  • Proportion of subjects with on-treatment Interferon (IFN)-associated symptoms as determined by adverse event reporting [ Time Frame: Up to 48 weeks of treatment ] [ Designated as safety issue: Yes ]

    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)


Estimated Enrollment: 300
Study Start Date: April 2013
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
 Biological: Peginterferon Lambda-1a
Other Name: BMS-914143
Drug: Ribavirin
Other Name: Ribasphere
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 Name: Ribasphere
Biological: Peginterferon alfa-2a
Other Name: Pegasys

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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) or cirrhosis (from any time prior to randomization). Where approved for staging of liver disease, non-invasive imaging may be used to assess the extent of liver disease. Subjects with compensated cirrhosis can enroll and will be capped at 30%
  • 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 or hepatitis D virus (HDV) 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 decompensated cirrhosis based on radiologic criteria or biopsy results and clinical criteria
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01754974

Contacts
Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email: Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.

Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
BMS Clinical Trial Information  This link exits the ClinicalTrials.gov site
BMS clinical trial educational resource  This link exits the ClinicalTrials.gov site
Investigator Inquiry form  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01754974     History of Changes
Other Study ID Numbers: AI452-033, 2012-003508-11
Study First Received: December 19, 2012
Last Updated: April 10, 2013
Health Authority: Korea: Food and Drug Administration
Brazil: National Health Surveillance Agency
Brazil: Ministry of Health
Brazil: National Committee of Ethics in Research
Czech Republic: State Institute for Drug Control
Hungary: National Institute of Pharmacy
Mexico: Ministry of Health
Poland: National Institute of Medicines
Poland: Ministry of Health
Poland: Ministry of Science and Higher Education
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romania: National Medicines Agency
Russia: Ethics Committee
Russia: Ministry of Health of the Russian Federation
Russia: FSI Scientific Center of Expertise of Medical Application
Turkey: Ministry of Health

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
 Ribavirin
Peginterferon alfa-2a
Interferon-alpha
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013