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

NCT01754974 | Completed Phase 3

• 2 other identifiers: AI452-0332012-003508-11
• Study Type: interventional
• Target: 40
• Locations: 3 countries
• Sites: 16

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.

Conditions

Hepatitis C Virus (HCV)

Outcome Measures

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

  * ANC = Absolute Neutrophil Count * Hb = Hemoglobin

  Up to 48 weeks of treatment

Secondary Outcomes (6)

• 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)

  At Post-Treatment Follow-up Week 24

• Proportion of subjects with Rapid Virologic Response (RVR) (HCV RNA not detected)

  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

  Up to 48 weeks of treatment

• Proportion of subjects with dose reductions through end of treatment

  Up to 48 weeks of treatment

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

  Up to 48 weeks of treatment

Study Arms (2)

Peginterferon Lambda-1a + Ribavirin

EXPERIMENTAL

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; Drug: Ribavirin

Peginterferon alfa-2a + Ribavirin

ACTIVE COMPARATOR

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; Biological: Peginterferon alfa-2a

Interventions

Peginterferon Lambda-1a BIOLOGICAL

Also known as: BMS-914143

Peginterferon Lambda-1a + Ribavirin

Ribavirin DRUG

Also known as: Ribasphere

Peginterferon Lambda-1a + Ribavirin; Peginterferon alfa-2a + Ribavirin

Peginterferon alfa-2a BIOLOGICAL

Also known as: Pegasys

Peginterferon alfa-2a + Ribavirin

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (16)

Local Institution

Hradec Králové, 500 05, Czechia

Location

Local Institution

Prague, 140 00, Czechia

Location

Local Institution

Ústí nad Labem, 400 01, Czechia

Location

Local Institution

Guadalajara, Jalisco, 44500, Mexico

Location

Local Institution

Guadalajara, Jalisco, 44650, Mexico

Location

Local Institution

Distrito Federal, Mexico City, 03720, Mexico

Location

Local Institution

Mexico City, Mexico City, 07760, Mexico

Location

Local Institution

México, State of Mexico, 06700, Mexico

Location

Local Institution

Chungcheongnam-do, 330-930, South Korea

Location

Local Institution

Daegu, 700-821, South Korea

Location

Local Institution

Gangwon-do, 200-704, South Korea

Location

Local Institution

Gyeonggi-do, 420-717, South Korea

Location

Local Institution

Gyeonggi-do, 463-707, South Korea

Location

Local Institution

Gyeongsangnam-do, 626-770, South Korea

Location

Local Institution

Incheon, 403-720, South Korea

Location

Local Institution

Seoul, 156-755, South Korea

Location

Related Links

• BMS clinical trial educational resource
• Investigator Inquiry form

MeSH Terms

Conditions

Hepatitis C

Interventions

peginterferon lambda-1a; Ribavirin; peginterferon alfa-2a

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2012
• First Posted: December 21, 2012
• Study Start: March 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: January 28, 2015

Record last verified: 2013-12

Locations

ME (5); KR (8); CZ (3)