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

Hepatitis C Virus (HCV) Clinical Trial

— BASIS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01754974
• Other study ID #: AI452-033
• Secondary ID: 2012-003508-11
• Status: Completed
• Phase: Phase 3
• First received: December 19, 2012
• Last updated: January 27, 2015
• Start date: March 2013
• Est. completion date: September 2014

Study information

• Verified date: December 2013
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug AdministrationBrazil: National Health Surveillance AgencyBrazil: Ministry of HealthBrazil: National Committee of Ethics in ResearchCzech Republic: State Institute for Drug ControlHungary: National Institute of PharmacyMexico: Ministry of HealthPoland: National Institute of MedicinesPoland: Ministry of HealthPoland: Ministry of Science and Higher EducationPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsRomania: National Medicines AgencyRussia: Ethics CommitteeRussia: Ministry of Health of the Russian FederationRussia: FSI Scientific Center of Expertise of Medical ApplicationTurkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C Virus (HCV)

Intervention

Biological:
• Peginterferon Lambda-1a

Drug:
• Ribavirin

Biological:
• Peginterferon alfa-2a

Locations

Country	Name	City	State
Czech Republic	Local Institution	Hradec Kralove
Czech Republic	Local Institution	Praha 4
Czech Republic	Local Institution	Usti Nad Labem
Korea, Republic of	Local Institution	Chungcheongnam-do
Korea, Republic of	Local Institution	Daegu
Korea, Republic of	Local Institution	Gangwon-do
Korea, Republic of	Local Institution	Gyeonggi-do
Korea, Republic of	Local Institution	Gyeonggi-do
Korea, Republic of	Local Institution	Gyeongsangnam-do
Korea, Republic of	Local Institution	Incheon
Korea, Republic of	Local Institution	Seoul
Mexico	Local Institution	Distrito Federal
Mexico	Local Institution	Guadalajara	Jalisco
Mexico	Local Institution	Guadalajara	Jalisco
Mexico	Local Institution	Mexico	Distrito Federal
Mexico	Local Institution	Mexico City	Estado De Mexico

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

Czech Republic,  Korea, Republic of,  Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No
Secondary	Proportion of subjects with Rapid Virologic Response (RVR) (HCV RNA not detected)		On treatment Week 4 (of an up to 48-week treatment period)	No
Secondary	Proportion of subjects with on-treatment Serious Adverse Events (SAEs) through end of treatment		Up to 48 weeks of treatment	Yes
Secondary	Proportion of subjects with dose reductions through end of treatment		Up to 48 weeks of treatment	Yes
Secondary	Proportion of subjects who discontinue due to Adverse Events (AEs) through end of treatment		Up to 48 weeks of treatment	Yes
Secondary	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)	Up to 48 weeks of treatment	Yes

External Links

•   BMS clinical trial educational resource
•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls
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