Phase III Hallmark DUAL: ASV+DCV (Nulls/Partials, Intolerants/Ineligibles. Naives)

Hepatitis C Virus Clinical Trial

— Hallmark DUAL  

Official title:

A Phase 3 Study With Asunaprevir and Daclatasvir (DUAL) for Null or Partial Responders to Peginterferon Alfa and Ribavirin (P/R), Intolerant or Ineligible to P/R Subjects and Treatment-Naive Subjects With Chronic Hepatitis C Genotype 1b Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01581203
• Other study ID #: AI447-028
• Secondary ID: 2011-005446-35
• Status: Completed
• Phase: Phase 3
• First received: April 18, 2012
• Last updated: September 23, 2015
• Start date: May 2012
• Est. completion date: September 2014

Study information

• Verified date: September 2015
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationKorea: Food and Drug AdministrationTaiwan: Department of HealthTaiwan: National Bureau of Controlled DrugsAustralia: Department of Health and Ageing Therapeutic Goods AdministrationAustralia: National Health and Medical Research CouncilArgentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaCanada: Health CanadaRussia: Ethics CommitteeRussia: Ministry of Health of the Russian FederationRussia: FSI Scientific Center of Expertise of Medical ApplicationGermany: Federal Institute for Drugs and Medical DevicesGermany: Ministry of HealthFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Spain: Spanish Agency of MedicinesSingapore: Clinical Trials & Epidemiology Research Unit (CTERU)New Zealand: MedsafeNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Italy: Ministry of HealthItaly: National Bioethics CommitteeItaly: National Institute of HealthItaly: National Monitoring Centre for Clinical Trials - Ministry of HealthItaly: The Italian Medicines AgencyIreland: Irish Medicines BoardUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyIsrael: Israeli Health Ministry Pharmaceutical AdministrationPoland: National Institute of MedicinesPoland: Ministry of HealthPoland: Ministry of Science and Higher EducationPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsBrazil: National Health Surveillance AgencyBrazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to estimate efficacy, as determined by the proportion of subjects with Sustained virologic response at post-treatment Week 12 (SVR12), defined as Hepatitis C virus (HCV) Ribonucleic acid (RNA) < Limit of quantitation (LOQ) at post-treatment Week 12, for subjects who are prior null or partial responders to P/R or who are treatment-naive.

Description:

Allocation: Treatment naive cohort: Randomized Controlled Trial, Null/partial responder and intolerant/ineligible cohorts: N/A (Single arm study)

Masking: Treatment naive cohort: Double Blind, Null/partial responder and intolerant/ineligible cohorts: Open

Intervention Model: Treatment naive cohort: Parallel, Null/partial responder and intolerant/ineligible cohorts: Single group

Recruitment information / eligibility

• Status: Completed
• Enrollment: 748
• Est. completion date: September 2014
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• Males and females, = 18 years of age

• HCV Genotype 1b who previously failed treatment with peginterferon alfa and ribavirin, classified as previous null or partial responders based on previous therapy, OR intolerant or ineligible to P/R due to neutropenia, anemia, depression or thrombocytopenia with fibrosis/cirrhosis, OR treatment naive

• HCV RNA = 10,000 IU/mL

• Seronegative for Human immunodeficiency virus (HIV) and Hepatitis B surface antigen (HBsAg)

• Subjects with compensated cirrhosis are permitted (compensated cirrhotics are capped at approximately 25% of treated population)

Exclusion Criteria:

• Prior treatment of HCV with HCV direct acting antiviral (DAA)

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

• Evidence of decompensated liver disease including, but not limited to, a history or presence of ascites, bleeding varices, or hepatic encephalopathy

• Diagnosed or suspected hepatocellular carcinoma or other malignancies

• Uncontrolled diabetes or hypertension

Study Design

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis C
• Hepatitis C Virus

Intervention

Drug:
• Asunaprevir (ASV)

• Daclatasvir (DCV)

• Pegylated-interferon alfa 2a (PegIFN)

• Ribavirin (RBV)

Locations

Country	Name	City	State
Argentina	Local Institution	Buenos Aires
Argentina	Local Institution	Ciudad De Buenos Aires	Buenos Aires
Argentina	Local Institution	Prov De Santa Fe	Santa Fe
Australia	Local Institution	Adelaide	South Australia
Australia	Local Institution	Bedford Park, Sa	South Australia
Australia	Local Institution	Clayton	Victoria
Australia	Local Institution	Darlinghurst	New South Wales
Australia	Local Institution	Fitzroy	Queensland
Australia	Local Institution	Fremantle	Western Australia
Australia	Local Institution	Heidelberg	Victoria
Australia	Local Institution	Kogarah	New South Wales
Australia	Local Institution	Melbourne	Victoria
Australia	Local Institution	Nedlands	Western Australia
Australia	Local Institution	Perth	Western Australia
Australia	Local Institution	Randwick	New South Wales
Austria	Local Institution	Graz
Austria	Local Institution	Linz
Austria	Local Institution	Salzburg
Austria	Local Institution	Wien
Austria	Local Institution	Wien
Canada	Clinique Medicale Lactuel	Montreal	Quebec
Canada	Jewish General Hospital	Montreal	Quebec
Canada	Alpha-Recherche Clinique	Quebec
Canada	Toronto General Hospital-University Health Network	Toronto	Ontario
Canada	Toronto Liver Centre	Toronto	Ontario
Canada	Gastrointestinal Research Institute (G.I.R.I.)	Vancouver	British Columbia
Canada	Toronto Digestive Disease Associates, Inc.	Vaughan	Ontario
Canada	Percuro Clinical Research Ltd	Victoria	British Columbia
France	Local Institution	Clichy Cedex
France	Local Institution	Creteil
France	Local Institution	Lyon Cedex 04
France	Local Institution	Marseille Cedex 08
France	Local Institution	Paris
France	Local Institution	Paris Cedex 13
France	Local Institution	Toulouse
France	Local Institution	Vandoeuvre Les Nancy
Germany	Local Institution	Berlin
Germany	Local Institution	Berlin
Germany	Local Institution	Bonn
Germany	Local Institution	Essen
Germany	Local Institution	Frankfurt
Germany	Local Institution	Hamburg
Germany	Local Institution	Hannover
Germany	Local Institution	Muenchen
Ireland	Local Institution	Dublin
Ireland	Local Institution	Dublin
Israel	Local Institution	Haifa
Israel	Local Institution	Jerusalem
Israel	Local Institution	Jerusalem
Israel	Local Institution	Tel Aviv
Israel	Local Institution	Tel Hashomer
Israel	Local Institution	Zafed
Italy	Local Institution	Messina
Italy	Local Institution	Milano
Italy	Local Institution	Roma
Italy	Local Institution	Torino
Korea, Republic of	Local Institution	Busan
Korea, Republic of	Local Institution	Busan
Korea, Republic of	Local Institution	Busan
Korea, Republic of	Local Institution	Daegu
Korea, Republic of	Local Institution	Daegu
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	Incheon
Korea, Republic of	Local Institution	Seoul
Korea, Republic of	Local Institution	Seoul
Korea, Republic of	Local Institution	Seoul
Korea, Republic of	Local Institution	Seoul
Netherlands	Local Institution	Amsterdam
Netherlands	Local Institution	Leiden
Netherlands	Local Institution	Rotterdam
New Zealand	Local Institution	Auckland
New Zealand	Local Institution	Hamilton
New Zealand	Local Institution	Wellington
Poland	Local Institution	Bialystok
Poland	Local Institution	Wroclaw
Russian Federation	Local Institution	Chelyabinsk
Russian Federation	Local Institution	Krasnoyarsk
Russian Federation	Local Institution	Moscow
Russian Federation	Local Institution	Moscow
Russian Federation	Local Institution	Saint-Petersburg
Russian Federation	Local Institution	Samara
Russian Federation	Local Institution	Smolensk
Russian Federation	Local Institution	Tyumen
Spain	Local Institution	Alicante
Spain	Local Institution	Barcelona
Spain	Local Institution	Madrid
Spain	Local Institution	Valencia
Taiwan	Local Institution	Taichung
Taiwan	Local Institution	Taichung
Taiwan	Local Institution	Tainan
Taiwan	Local Institution	Taipei
Taiwan	Local Institution	Taipei
United Kingdom	Local Institution	Glasgow	Lanarkshire
United Kingdom	Local Institution	London	Greater London
United Kingdom	Local Institution	London	Greater London
United Kingdom	Local Institution	Manchester	Greater Manchester
United States	University Of Colorado Denver And Hospital	Aurora	Colorado
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
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	Henry Ford Health System	Detroit	Michigan
United States	Duke University Medical Center	Durham	North Carolina
United States	Uf Hepatology Research At Ctrb	Gainesville	Florida
United States	Baylor College Of Medicine	Houston	Texas
United States	Vamc	Houston	Texas
United States	Scripps Clinic	La Jolla	California
United States	Scpmg/ Kaiser Permanente Los Angeles Medical Center	Los Angeles	California
United States	Johns Hopkins Medical Institutions	Lutherville	Maryland
United States	Dean Clinic	Madison	Wisconsin
United States	North Shore-Long Island Jewish Health System	Manhasset	New York
United States	The Health Care Authority For Baptist Health	Montgomery	Alabama
United States	Weill Cornell Medical College	New York	New York
United States	Washington University School Of Medicine	Saint Louis	Missouri
United States	Alamo Medical Research	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Canada,  France,  Germany,  Ireland,  Israel,  Italy,  Korea, Republic of,  Netherlands,  New Zealand,  Poland,  Russian Federation,  Spain,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of treated subjects with SVR12, defined as HCV RNA < LOQ at post treatment Week 12, for subjects who are prior null or partial responders to P/R or are treatment-naive		At 12 weeks post-treatment	No
Secondary	Proportion of treated subjects with SVR12, defined as HCV RNA < LOQ at post-treatment Week 12, for subjects who are intolerant or ineligible to P/R		Post-treatment Week 12	No
Secondary	On treatment safety, as measured by frequency of Serious Adverse Events (SAEs) and discontinuations due to Adverse Events (AEs)		End of Treatment (up to 48 weeks) plus 7 days	Yes
Secondary	Differences in rates of selected grade 3-4 laboratory abnormalities during the first 12 weeks between treatments (ASV + DCV vs PBO) for naive subjects		Up to first 12 weeks	No
Secondary	Proportion of genotype 1b subjects with SVR12 (HCV RNA < LOQ at post treatment Week 12) by the rs12979860 single nucleotide polymorphisms (SNP) in the IL28B gene for each cohort		Post-treatment Week 12	No
Secondary	Proportion of genotype 1b subjects with HCV RNA undetectable	eRVR = Extended rapid virologic response, EOT = End of treatment	At weeks 1, 2, 4, 6, 8 and 12; at both Weeks 4 and 12 [eRVR]; EOT (up to 24 weeks), post-treatment Week 12, or post-treatment Week 24 for each cohort	No
Secondary	Proportion of genotypes 1b subjects with HCV RNA < LOQ		At weeks 1, 2, 4, 6, 8 and 12; at both Weeks 4 and 12 [VR(4&12)]; EOT (up to 24 weeks), post-treatment Week 24 (SVR24) for each cohort	No
Secondary	Proportion of subjects with anemia		At 12 weeks post-treatment	No
Secondary	Proportion of subjects with rash		At 12 weeks post-treatment	No

External Links

•   BMS clinical trial educational resource
•   BMS Clinical Trial Information
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•   Investigator Inquiry form