Safety and Efficacy Study of Pegylated Interferon Lambda With and Without Daclatasvir, Compared to Pegylated Interferon Alfa, Plus Ribavirin in Subjects With Hepatitis C Genotype 2 and 3 - Full Text View

Purpose

The purpose of this study is to determine if 24 weeks of treatment with Pegylated Interferon Lambda plus Ribavirin and 12 weeks of treatment with Pegylated Interferon Lambda plus Ribavirin and Daclatasvir will be safe and effective for treatment of hepatitis C compared to 24 weeks of treatment with Pegylated Interferon Alfa-2a plus Ribavirin

Condition	Intervention	Phase
Hepatitis C Virus (HCV)	Biological: Pegylated interferon lambda (pegIFNλ) Biological: Pegylated interferon alfa-2a (pegIFNα-2a) Drug: Ribavirin Drug: Daclatasvir Drug: Placebo matching Daclatasvir	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 Phase 3, Randomized, Double-Blind, Controlled Study Evaluating the Efficacy and Safety of Peginterferon Lambda-1a, With and Without Daclatasvir, Compared to Peginterferon Alfa-2a, Each in Combination With Ribavirin, in the Treatment of Naïve Genotype 2 and 3 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:

Proportion of subjects who achieve Sustained Virologic Response at post-treatment follow-up week 12 (SVR12) [ Time Frame: Post-treatment follow-up week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportion of subjects with Rapid virologic response (RVR) [undetectable Hepatitis C virus (HCV) Ribonucleic acid (RNA)] [ Time Frame: On-treatment Week 4 ] [ Designated as safety issue: No ]
Proportion of subjects with treatment emergent cytopenic abnormalities (anemia as defined by Hb < 10 g/dL, neutropenia as defined by ANC < 750 mm3 or thrombocytopenia as defined by platelets < 50,000 mm3) [ Time Frame: Up to week 12 or week 24 ] [ Designated as safety issue: Yes ]
Hb = Hemoglobin ANC = Absolute neutrophil count
Proportion of subjects with on-treatment interferon-associated flu-like symptoms (as defined by pyrexia or chills or pain) [ Time Frame: Up to week 12 or week 24 ] [ Designated as safety issue: Yes ]
Proportion of subjects with on-treatment musculoskeletal symptoms (as defined by arthralgia or myalgia or back pain) [ Time Frame: Up to week 12 or week 24 ] [ Designated as safety issue: Yes ]
Proportion of subjects with Sustained Virologic Response at post-treatment follow-up week 24 (SVR24) by treatment group [ Time Frame: Post-treatment week 24 ] [ Designated as safety issue: No ]
Proportion of subjects with on-treatment Serious adverse events (SAEs) [ Time Frame: Up to week 12 or week 24 ] [ Designated as safety issue: Yes ]
Proportion of subjects with dose reductions [ Time Frame: Up to week 12 or week 24 ] [ Designated as safety issue: Yes ]
Proportion of subjects who discontinue due to Adverse events (AEs) [ Time Frame: Up to week 12 or week 24 ] [ Designated as safety issue: Yes ]
Proportion of subjects with SVR12 in subjects with genotype-3 (GT-3) chronic HCV infection [ Time Frame: Post-treatment follow-up week 12 ] [ Designated as safety issue: No ]
Proportion of subjects with on-treatment constitutional symptoms (fatigue or asthenia) [ Time Frame: Up to week 12 or week 24 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	880
Study Start Date:	July 2012
Estimated Study Completion Date:	September 2014
Estimated Primary Completion Date:	March 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm 1: pegIFNλ + Ribavirin + Placebo matching Daclatasvir	Biological: Pegylated interferon lambda (pegIFNλ) Syringe, Subcutaneous, 180 μg, Once weekly, 24 weeks Other Name: BMS-914143 Drug: Ribavirin Tablets, Oral, 400 mg, Twice daily, 24 weeks Other Name: Ribasphere Drug: Placebo matching Daclatasvir Tablets, Oral, 0 mg, Once daily, 12 weeks
Experimental: Arm 2: pegIFNλ + Ribavirin + Daclatasvir	Biological: Pegylated interferon lambda (pegIFNλ) Syringe, Subcutaneous, 180 μg, Once weekly, 12 weeks Other Name: BMS-914143 Drug: Ribavirin Tablets, Oral, 400 mg, Twice daily, 12 weeks Other Name: Ribasphere Drug: Daclatasvir Tablets, Oral, 60 mg, Once daily, 12 weeks Other Name: BMS-790052
Experimental: Arm 3: pegIFNα-2a + Ribavirin + Placebo matching Daclatasvir	Biological: Pegylated interferon alfa-2a (pegIFNα-2a) Syringe, Subcutaneous, 180 μg, Once weekly, 24 weeks Other Name: Pegasys Drug: Ribavirin Tablets, Oral, 400 mg, Twice daily, 24 weeks Other Name: Ribasphere Drug: Placebo matching Daclatasvir Tablets, Oral, 0 mg, Once daily, 12 weeks

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Chronic hepatitis C, Genotype 2 or 3
Naïve to prior anti-HCV therapy

Exclusion Criteria:

Infected with HCV other than Genotype 2 or 3
Positive Hepatitis B surface antigen (HBsAg), or Human immunodeficiency virus-1 (HIV-1)/HIV-2 antibody at screening
Evidence of liver disease other than HCV
Active substance abuse
Evidence of decompensated cirrhosis

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01616524

Contacts

Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email:		Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.

Show 90 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trial Information This link exits the ClinicalTrials.gov site

BMS clinical trial educational resource 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:	NCT01616524 History of Changes
Other Study ID Numbers:	AI452-017, 2011-004885-14
Study First Received:	June 7, 2012
Last Updated:	March 25, 2013
Health Authority:	United States: Food and Drug Administration Australia: Department of Health and Ageing Therapeutic Goods Administration Australia: National Health and Medical Research Council New Zealand: Medsafe Finland: Finnish Medicines Agency Finland: Data Protection Board Finland: National Advisory Board on Health Care Ethics France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Mexico: Federal Commission for Sanitary Risks Protection Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment Japan: Ministry of Health, Labor and Welfare Japan: Pharmaceuticals and Medical Devices Agency Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica 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: National Committee of Ethics in Research Chile: Instituto de Salud Publica de Chile India: Central Drugs Standard Control Organization India: Indian Council of Medical Research India: Ministry of Health India: Ministry of Science and Technology Russia: Ethics Committee Russia: Ministry of Health of the Russian Federation Russia: FSI Scientific Center of Expertise of Medical Application 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 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

Safety and Efficacy Study of Pegylated Interferon Lambda With and Without Daclatasvir, Compared to Pegylated Interferon Alfa, Plus Ribavirin in Subjects With Hepatitis C Genotype 2 and 3 (PRINCIPAL)