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

Bristol-Myers Squibb40 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Hepatitis C Virus (HCV)

Interventions

Peginterferon Lambda-1aBIOLOGICAL

RibavirinDRUG

Peginterferon alfa-2aBIOLOGICAL

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (16)

Local Institution

Hradec Králové, Czechia

Local Institution

Prague, Czechia

Local Institution

Ústí nad Labem, Czechia

Outcomes

Primary Outcomes

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

Time frame: Up to 48 weeks of treatment

Secondary Outcomes

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

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)

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

Time frame: Up to 48 weeks of treatment

Proportion of subjects with dose reductions through end of treatment

Time frame: 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

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)

Data from ClinicalTrials.gov

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