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Completed

NCT Number: NCT01754974

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

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.

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Key information

Conditions

Hepatitis C Virus (HCV) Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis C Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Local Institution, Hradec Králové, Czechia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Peginterferon Lambda-1a

Biological

Other names: BMS-914143

Ribavirin

Drug

Other names: Ribasphere

peginterferon alfa-2a

Biological

Other names: Pegasys

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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)

  3. Proportion of subjects with on-treatment Serious Adverse Events (SAEs) through end of treatment

    Time frame: Up to 48 weeks of treatment

  4. Proportion of subjects with dose reductions through end of treatment

    Time frame: Up to 48 weeks of treatment

  5. Proportion of subjects who discontinue due to Adverse Events (AEs) through end of treatment

    Time frame: Up to 48 weeks of treatment

  6. 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)

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Acronym: BASIS

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 21, 2012
Registry last updated
Jan 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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