Study Comparing BMS-790052 (Daclatasvir) to Telaprevir Combined With Peginterferon Alfa-2a and Ribavirin in Untreated Hepatitis C Patients

Hepatitis C Clinical Trial

— COMMAND-3  

Official title:

A Phase 3 Evaluation of BMS-790052 (Daclatasvir) Compared With Telaprevir in Combination With Peginterferon Alfa-2a and Ribavirin in Treatment-Naive Patients With Chronic Hepatitis C

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01492426
• Other study ID #: AI444-052
• Secondary ID: 2011-004237-14
• Status: Completed
• Phase: Phase 3
• First received: December 13, 2011
• Last updated: May 5, 2014
• Start date: January 2012
• Est. completion date: March 2014

Study information

• Verified date: May 2014
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaAustria: Federal Office for Safety in Health CareAustralia: Department of Health and Ageing Therapeutic Goods AdministrationAustralia: National Health and Medical Research CouncilBrazil: National Health Surveillance AgencyBrazil: National Committee of Ethics in ResearchCanada: Health CanadaDenmark: Danish Dataprotection AgencyDenmark: Danish Medicines AgencyDenmark: The Danish National Committee on Biomedical Research EthicsFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Ministry of HealthGermany: Federal Institute for Drugs and Medical DevicesIreland: Irish Medicines BoardIsrael: Israeli Health Ministry Pharmaceutical AdministrationItaly: Ministry of HealthItaly: National Bioethics CommitteeItaly: National Monitoring Centre for Clinical Trials - Ministry of HealthItaly: The Italian Medicines AgencyPoland: National Institute of MedicinesPoland: Ministry of HealthPoland: Ministry of Science and Higher EducationPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsRussia: Ethics CommitteeRussia: Ministry of Health of the Russian FederationRussia: FSI Scientific Center of Expertise of Medical ApplicationSpain: Spanish Agency of MedicinesSwitzerland: SwissmedicUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the effectiveness of BMS-790052 (Daclatasvir) and Telaprevir when given in combination with Peginterferon alfa-2a and Ribavirin in genotype 1b patients

Description:

Allocation: Randomized Stratified

Recruitment information / eligibility

• Status: Completed
• Enrollment: 605
• Est. completion date: March 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects chronically infected with HCV genotype 1a or 1b

• HCV RNA viral load = 10,000 IU/mL

• No prior treatment including but not limited to interferon, ribavirin and direct-acting antivirals

• if no prior history of cirrhosis liver biopsy within 3 years or Fibroscan® within 1 year

• Body Mass Index (BMI) of 18 to 35 kg/m2

• Negative for Human immunodeficiency virus (HIV) and Hepatitis B

Exclusion Criteria:

• Evidence of decompensated liver disease

• Evidence of medical condition contributing to chronic liver disease other than HCV

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C

Intervention

Drug:
• BMS-790052 (Daclatasvir)
Film coated Tablet, Oral, 60 mg, Once daily, 24 weeks
• Telaprevir
Film coated Tablet, Oral, 750 mg, three times daily, 12 weeks
• Peginterferon alfa-2a
Solution for Injection, Subcutaneous injection, 180 µg, Weekly, 24 or 48 weeks
• Ribavirin
Film coated Tablet, Oral, 1000 mg or 1200 mg based on weight, twice daily, 24 or 48 weeks

Locations

Country	Name	City	State
Argentina	Local Institution	Ciudad De Buenos Aires	Buenos Aires
Argentina	Local Institution	Ciudad De Buenos Aires	Buenos Aires
Argentina	Local Institution	Prov De Santa Fe	Santa Fe
Argentina	Local Institution	Prov. Buenos Aires	Buenos Aires
Australia	Local Institution	Adelaide	South Australia
Australia	Local Institution	Camperdown	New South Wales
Australia	Local Institution	Fitzroy	Victoria
Australia	Local Institution	Greenslopes Qld	Queensland
Australia	Local Institution	Penrith	New South Wales
Australia	Local Institution	Prahran	Victoria
Australia	Local Institution	Westmead Nsw	New South Wales
Austria	Local Institution	Linz
Austria	Local Institution	Wien
Austria	Local Institution	Wien
Brazil	Local Institution	Sao Paulo
Canada	Local Institution	Calgary	Alberta
Canada	Local Institution	Edmonton	Alberta
Canada	Local Institution	Ottawa	Ontario
Canada	Local Institution	Toronto	Ontario
Canada	Local Institution	Vancouver	British Columbia
Canada	Local Institution	Winnipeg	Manitoba
Denmark	Local Institution	Hvidovre
Denmark	Local Institution	Odense
France	Local Institution	Besancon
France	Local Institution	Bondy Cedex
France	Local Institution	Grenoble Cedex 09
France	Local Institution	Lille Cedex
France	Local Institution	Paris Cedex 12
France	Local Institution	Paris Cedex 13
France	Local Institution	Pessac
France	Local Institution	Strasbourg
Germany	Local Institution	Berlin
Germany	Local Institution	Berlin
Germany	Local Institution	Essen
Germany	Local Institution	Frankfurt
Germany	Local Institution	Freiburg
Germany	Local Institution	Hamburg
Germany	Local Institution	Hannover
Germany	Local Institution	Koeln
Israel	Local Institution	Haifa
Israel	Local Institution	Nazareth
Israel	Local Institution	Tel Aviv
Israel	Local Institution	Zefat
Italy	Local Institution	Bergamo
Italy	Local Institution	Cisanello (pisa)
Italy	Local Institution	Firenze
Italy	Local Institution	Napoli
Italy	Local Institution	Torino
Poland	Local Institution	Bialystok
Poland	Local Institution	Chorzow
Poland	Local Institution	Kielce
Poland	Local Institution	Myslowice
Poland	Local Institution	Raciborz
Poland	Local Institution	Wroclaw
Russian Federation	Local Institution	Moscow
Russian Federation	Local Institution	Moscow
Russian Federation	Local Institution	Moscow
Spain	Local Institution	Alcorcon
Spain	Local Institution	Barcelona
Spain	Local Institution	Barcelona
Spain	Local Institution	Valencia
Switzerland	Local Institution	Zurich
United Kingdom	Local Institution	Birmingham	West Midlands
United Kingdom	Local Institution	Edinburgh	Scotland
United Kingdom	Local Institution	Glasgow	Scotland
United Kingdom	Local Institution	London	Greater London
United States	Atlanta Medical Center	Atlanta	Georgia
United States	University Of Maryland	Baltimore	Maryland
United States	The Kirklin Clinic	Birmingham	Alabama
United States	University Of North Carolina At Chapel Hill School Of Med	Chapel Hill	North Carolina
United States	Carolinas Medical Center	Charlotte	North Carolina
United States	Northwestern University	Chicago	Illinois
United States	Rush University Medical Center	Chicago	Illinois
United States	Duke University Medical Center	Durham	North Carolina
United States	Brooke Army Medical Center	Ft. Sam Houston	Texas
United States	Baylor College Of Medicine	Houston	Texas
United States	Research Specialists Of Texas	Houston	Texas
United States	Va Long Beach Healthcare System	Long Beach	California
United States	Johns Hopkins University	Lutherville	Maryland
United States	Gastrointestinal Specialists Of Georgia	Marietta	Georgia
United States	Yale University School Of Medicine	New Haven	Connecticut
United States	Weill Cornell Medical College	New York	New York
United States	Orlando Immunology Center	Orlando	Florida
United States	Albert Einstein Medical Center	Philadelphia	Pennsylvania
United States	Mayo Clinic Arizona	Phoenix	Arizona
United States	The Miriam Hospital	Providence	Rhode Island
United States	University Gastroenterology	Providence	Rhode Island
United States	Minnesota Gastroenterology, P.A.	Saint Paul	Minnesota
United States	Alamo Medical Research	San Antonio	Texas
United States	Medical Associates Research Group	San Diego	California
United States	Saint Louis University Gastroenterology & Hepatology	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Brazil,  Canada,  Denmark,  France,  Germany,  Israel,  Italy,  Poland,  Russian Federation,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of genotype 1b patients with SVR12, defined as HCV RNA less than limit of quantitation at follow-up Week 12 in each group	HCV - Hepatitis C virus; RNA - Ribonucleic Acid; SVR - Sustained Virologic Response	Follow up Week 12	No
Secondary	Proportion of genotype 1b patients with hemoglobin value less than 10 g/dL		Up to Week 12	Yes
Secondary	Proportion of genotype 1b patients with rash events		Up to Week 12	Yes
Secondary	Proportion of genotype1b patients with HCV RNA undetectable Week 12		Week 12	No
Secondary	Proportion of genotype 1b patients with HCV RNA undetectable Week 4		Week 4	No
Secondary	Proportion of genotype 1b patients with HCV RNA undetectable Weeks 4 and 12		Week 4 and 12	No
Secondary	Proportion of genotype 1b patients with SVR24, defined as HCV RNA < Limit of Quantification (LOQ) at follow-up Week 24 for each cohort		Follow up Week 24	No
Secondary	Proportion of genotype 1b patients with SVR12 based on IL28B rs12979860 Single nucleotide polymorphism (SNP) genotype (CC or non-CC)		Follow up Week 12	No
Secondary	Proportion of genotype 1a patients with SVR12 defined as HCV RNA < LOQ at follow-up Week 12 for each cohort		Follow up Week 12	No

External Links

•   BMS clinical trial educational resource
•   BMS Clinical Trial Information
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   Investigator Inquiry form