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

Study Description

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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.

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

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	40 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, 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
Study Start Date :	March 2013
Actual Primary Completion Date :	September 2014
Actual Study Completion Date :	September 2014

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

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 Outcome Measures :

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)

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:	All
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). 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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Czech Republic
Local Institution
Hradec Kralove, Czech Republic, 500 05
Local Institution
Praha 4, Czech Republic, 140 00
Local Institution
Usti Nad Labem, Czech Republic, 400 01
Korea, Republic of
Local Institution
Chungcheongnam-do, Korea, Republic of, 330-930
Local Institution
Daegu, Korea, Republic of, 700-821
Local Institution
Gangwon-do, Korea, Republic of, 200-704
Local Institution
Gyeonggi-do, Korea, Republic of, 420-717
Local Institution
Gyeonggi-do, Korea, Republic of, 463-707
Local Institution
Gyeongsangnam-do, Korea, Republic of, 626-770
Local Institution
Incheon, Korea, Republic of, 403-720
Local Institution
Seoul, Korea, Republic of, 156-755
Mexico
Local Institution
Mexico, Distrito Federal, Mexico, 07760
Local Institution
Mexico City, Estado De Mexico, Mexico, 06700
Local Institution
Guadalajara, Jalisco, Mexico, 44500
Local Institution
Guadalajara, Jalisco, Mexico, 44650
Local Institution
Distrito Federal, Mexico, 03720

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:	Bristol-Myers Squibb	Bristol-Myers Squibb

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

BMS Clinical Trial Information 

BMS clinical trial educational resource 

Investigator Inquiry form 

FDA Safety Alerts and Recalls 

Responsible Party:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT01754974 History of Changes
Other Study ID Numbers:	AI452-033; 2012-003508-11 ( EudraCT Number )
First Posted:	December 21, 2012
Last Update Posted:	January 28, 2015
Last Verified:	December 2013

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; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Antiviral Agents; Anti-Infective Agents; Immunologic Factors; Physiological Effects of Drugs