Safety and Efficacy Study of Pegylated Interferon Lambda Versus Pegylated Interferon Alfa, Plus Ribavirin in Subjects With Hepatitis C - Full Text View

Purpose

The purpose of this study is to determine if 48 weeks of therapy with Pegylated Interferon Lambda plus Ribavirin is effective and safe for a treatment of chronic hepatitis C (CHC) compared to therapy with Pegylated Interferon Alfa-2a plus Ribavirin.

Condition	Intervention	Phase
Hepatitis C Virus (HCV)	Biological: Pegylated Interferon Lambda Biological: Pegylated Interferon Alfa-2a Drug: Ribavirin	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Double-Blinded Randomized Control Study Evaluating the Efficacy and Safety of Pegylated Lambda Interferon Compared to Pegylated Alfa-2a Interferon, Each in Combination With Ribavirin, in the Treatment of Naive Genotype 1 or 4 Chronic Hepatitis C Subjects

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis C

Drug Information available for: Interferon Ribavirin Interferon Alfa-2a Peginterferon Alfa-2a

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

Efficacy of Lambda + Ribavirin (RBV) compared to Alfa + RBV in achieving a sustained virological response [ Time Frame: At follow-up Week 24 (SVR24) following 48 weeks of treatment ] [ Designated as safety issue: Yes ]
The safety of Lambda + RBV compared to Alfa + RBV in reducing cytopenic abnormalities [ Time Frame: From Day 1 to end of Week 48 on-treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Proportion of interferon-associated symptoms: a) Flu-like symptoms b) Musculoskeletal symptoms c) Neurologic symptoms d) Psychiatric symptoms e) Constitutional symptoms [ Time Frame: From Day 1 to end of Week 48 on-treatment ] [ Designated as safety issue: Yes ]

Enrollment:	0
Study Start Date:	March 2012
Estimated Study Completion Date:	August 2014
Estimated Primary Completion Date:	March 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm 1: Pegylated Interferon Lambda + Ribavirin	Biological: Pegylated Interferon Lambda Syringe, Subcutaneous, 180 μg, Once weekly, 48 weeks Other Name: BMS-914143 Drug: Ribavirin Tablets, Oral, 1000 or 1200 mg based on weight, Twice daily, 48 weeks Other Name: Ribasphere
Active Comparator: Arm 2: Pegylated Interferon Alfa-2a + Ribavirin	Biological: Pegylated Interferon Alfa-2a Syringe, Subcutaneous, 180 μg, Once weekly, 48 weeks Other Name: Pegasys Drug: Ribavirin Tablets, Oral, 1000 or 1200 mg based on weight, Twice daily, 48 weeks Other Name: Ribasphere

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Chronic hepatitis C, Genotype 1 or 4
HCV Ribonucleic acid (RNA) ≥ 100,000 IU/mL at screening
Liver biopsy documenting no cirrhosis (within prior 2 years) or cirrhosis (from any time prior to randomization). Where approved for staging of liver disease, non-invasive imaging may be used to assess the extent of liver disease. Subjects with compensated cirrhosis can enroll and will be capped at 10%
Naive to prior anti-HCV therapy

Exclusion Criteria:

Infected with HCV other than Genotype 1 or 4
Positive Hepatitis B surface antigen (HBsAg), or Human immunodeficiency virus-1 (HIV-1)/HIV-2 antibody or hepatitis D virus (HDV) 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 decompensated cirrhosis based on radiologic criteria or biopsy results and clinical criteria

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01447394

Show 100 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

Investigator Inquiry form This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT01447394 History of Changes
Other Study ID Numbers:	AI452-013, 2011-003748-31
Study First Received:	October 4, 2011
Last Updated:	February 2, 2012
Health Authority:	United States: Food and Drug Administration South Korea: Korea Food and Drug Administration (KFDA) Singapore: Clinical Trials & Epidemiology Research Unit (CTERU) Singapore: Domain Specific Review Boards Singapore: Health Sciences Authority Taiwan: Department of Health Taiwan: National Bureau of Controlled Drugs Hong Kong: Department of Health Brazil: National Health Surveillance Agency Brazil: Ethics Committee Chile: Instituto de Salud Publica de Chile Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos India: Central Drugs Standard Control Organization India: Indian Council of Medical Research India: Ministry of Health India: Ministry of Science and Technology Czech Republic: State Institute for Drug Control Hungary: National Institute of Pharmacy Poland: National Institute of Medicines Poland: Ministry of Health Poland: Ministry of Science and Higher Education Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Romania: National Medicines Agency Romania: Ministry of Public Health Russia: Ethics Committee Russia: Ministry of Health of the Russian Federation Russia: FSI Scientific Center of Expertise of Medical Application Turkey: Ministry of Health Egypt: Ministry of Health and Population Spain: Spanish Agency of Medicines Ireland: Irish Medicines Board Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) United Kingdom: Medicines and Healthcare Products Regulatory Agency Greece: Ethics Committee Greece: National Organization of Medicines Israel: Israeli Health Ministry Pharmaceutical Administration Italy: Ministry of Health Italy: National Bioethics Committee Italy: National Institute of Health Italy: National Monitoring Centre for Clinical Trials - Ministry of Health Italy: The Italian Medicines Agency Canada: Health Canada United States: Institutional Review Board

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
Interferon-alpha
Interferon Alfa-2a
Interferons
Ribavirin

Peginterferon alfa-2a
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013