Back to resultsPhase III Hallmark DUAL: ASV+DCV (Nulls/Partials, Intolerants/Ineligibles. Naives) (Hallmark DUAL)
Primary Purpose
Hepatitis C Virus
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Asunaprevir (ASV)
Daclatasvir (DCV)
Pegylated-interferon alfa 2a (PegIFN)
Ribavirin (RBV)
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis C Virus
Eligibility Criteria
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
Sites / Locations
- The Health Care Authority For Baptist Health
- Scripps Clinic
- Scpmg/ Kaiser Permanente Los Angeles Medical Center
- University Of Colorado Denver And Hospital
- Uf Hepatology Research At Ctrb
- Johns Hopkins Medical Institutions
- Beth Israel Deaconess Medical Center
- Henry Ford Health System
- Washington University School Of Medicine
- North Shore-Long Island Jewish Health System
- Weill Cornell Medical College
- University Of North Carolina At Chapel Hill School Of Med
- Carolinas Medical Center
- Duke University Medical Center
- Baylor College Of Medicine
- Vamc
- Alamo Medical Research
- Dean Clinic
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Gastrointestinal Research Institute (G.I.R.I.)
- Percuro Clinical Research Ltd
- Toronto General Hospital-University Health Network
- Toronto Liver Centre
- Toronto Digestive Disease Associates, Inc.
- Clinique Medicale Lactuel
- Jewish General Hospital
- Alpha-Recherche Clinique
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Arm 1: Null or Partial Responder to P/R (ASV + DCV)
Arm 2: Intolerant to or Ineligible for P/R (ASV + DCV)
Arm 3: Treatment naive (ASV + DCV)
Arm 4: Null or Partial Responder to P/R (ASV + DCV) 24/48 week
Arm Description
Asunaprevir 100 mg Capsules by mouth, Twice daily for 24 Weeks Daclatasvir 60 mg Tablet by mouth, Once daily for 24 Weeks
Asunaprevir 100 mg Capsules by mouth, Twice daily for 24 Weeks Daclatasvir 60 mg Tablet by mouth, Once daily for 24 Weeks
[Subjects will receive ASV + DCV for 24 weeks] followed by ASV + DCV for 24 weeks in protocol AI444026] Subjects meeting prespecified rescue criteria in the treatment naive cohort may have therapeutic rescue instituted with QUAD regimen (QUAD= ASV + DCV + P/R) Asunaprevir 100 mg Capsules by mouth, Twice daily for 24 or 48 Weeks Daclatasvir 60 mg Tablet by mouth, Once daily for 24 or 48 Weeks Pegylated-interferon alfa 2a (PegIFN) 180 mcg/0.5 mL injection subcutaneously (SC), once weekly for 24 or 48 weeks Ribavirin 1000 mg/1200 mg (total daily dose) tablet by mouth for 24 or 48 weeks
Subjects meeting prespecified rescue criteria in the null or partial responder cohort or active arm of the treatment naive cohort may have therapeutic rescue instituted with QUAD regimen (QUAD= ASV + DCV + P/R) Asunaprevir 100 mg Capsules by mouth, Twice daily for 24 or 48 Weeks Daclatasvir 60 mg Tablet by mouth, Once daily for 24 or 48 Weeks Pegylated-interferon alfa 2a (PegIFN) 180 mcg/0.5 mL injection subcutaneously (SC), once weekly for 24 or 48 weeks Ribavirin 1000 mg / 1200 mg (total daily dose) Tablet by mouth, for 24 or 48 weeks
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
On treatment safety, as measured by frequency of Serious Adverse Events (SAEs) and discontinuations due to Adverse Events (AEs)
Differences in rates of selected grade 3-4 laboratory abnormalities during the first 12 weeks between treatments (ASV + DCV vs PBO) for naive subjects
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
Proportion of genotype 1b subjects with HCV RNA undetectable
eRVR = Extended rapid virologic response, EOT = End of treatment
Proportion of genotypes 1b subjects with HCV RNA < LOQ
Proportion of subjects with anemia
Proportion of subjects with rash
Full Information
NCT ID
NCT01581203
First Posted
April 18, 2012
Last Updated
September 23, 2015
Sponsor
Bristol-Myers Squibb
1. Study Identification
Unique Protocol Identification Number
NCT01581203
Brief Title
Phase III Hallmark DUAL: ASV+DCV (Nulls/Partials, Intolerants/Ineligibles. Naives)
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C Virus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
748 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1: Null or Partial Responder to P/R (ASV + DCV)
Arm Type
Experimental
Arm Description
Asunaprevir 100 mg Capsules by mouth, Twice daily for 24 Weeks
Daclatasvir 60 mg Tablet by mouth, Once daily for 24 Weeks
Arm Title
Arm 2: Intolerant to or Ineligible for P/R (ASV + DCV)
Arm Type
Experimental
Arm Description
Asunaprevir 100 mg Capsules by mouth, Twice daily for 24 Weeks
Daclatasvir 60 mg Tablet by mouth, Once daily for 24 Weeks
Arm Title
Arm 3: Treatment naive (ASV + DCV)
Arm Type
Experimental
Arm Description
[Subjects will receive ASV + DCV for 24 weeks] followed by ASV + DCV for 24 weeks in protocol AI444026]
Subjects meeting prespecified rescue criteria in the treatment naive cohort may have therapeutic rescue instituted with QUAD regimen (QUAD= ASV + DCV + P/R)
Asunaprevir 100 mg Capsules by mouth, Twice daily for 24 or 48 Weeks
Daclatasvir 60 mg Tablet by mouth, Once daily for 24 or 48 Weeks
Pegylated-interferon alfa 2a (PegIFN) 180 mcg/0.5 mL injection subcutaneously (SC), once weekly for 24 or 48 weeks
Ribavirin 1000 mg/1200 mg (total daily dose) tablet by mouth for 24 or 48 weeks
Arm Title
Arm 4: Null or Partial Responder to P/R (ASV + DCV) 24/48 week
Arm Type
Experimental
Arm Description
Subjects meeting prespecified rescue criteria in the null or partial responder cohort or active arm of the treatment naive cohort may have therapeutic rescue instituted with QUAD regimen (QUAD= ASV + DCV + P/R)
Asunaprevir 100 mg Capsules by mouth, Twice daily for 24 or 48 Weeks
Daclatasvir 60 mg Tablet by mouth, Once daily for 24 or 48 Weeks
Pegylated-interferon alfa 2a (PegIFN) 180 mcg/0.5 mL injection subcutaneously (SC), once weekly for 24 or 48 weeks
Ribavirin 1000 mg / 1200 mg (total daily dose) Tablet by mouth, for 24 or 48 weeks
Intervention Type
Drug
Intervention Name(s)
Asunaprevir (ASV)
Other Intervention Name(s)
BMS-650032
Intervention Type
Drug
Intervention Name(s)
Daclatasvir (DCV)
Other Intervention Name(s)
BMS-790052
Intervention Type
Drug
Intervention Name(s)
Pegylated-interferon alfa 2a (PegIFN)
Other Intervention Name(s)
Pegasys
Intervention Type
Drug
Intervention Name(s)
Ribavirin (RBV)
Other Intervention Name(s)
Copegus
Primary Outcome Measure Information:
Title
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
Time Frame
At 12 weeks post-treatment
Secondary Outcome Measure Information:
Title
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
Time Frame
Post-treatment Week 12
Title
On treatment safety, as measured by frequency of Serious Adverse Events (SAEs) and discontinuations due to Adverse Events (AEs)
Time Frame
End of Treatment (up to 48 weeks) plus 7 days
Title
Differences in rates of selected grade 3-4 laboratory abnormalities during the first 12 weeks between treatments (ASV + DCV vs PBO) for naive subjects
Time Frame
Up to first 12 weeks
Title
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
Time Frame
Post-treatment Week 12
Title
Proportion of genotype 1b subjects with HCV RNA undetectable
Description
eRVR = Extended rapid virologic response, EOT = End of treatment
Time Frame
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
Title
Proportion of genotypes 1b subjects with HCV RNA < LOQ
Time Frame
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
Title
Proportion of subjects with anemia
Time Frame
At 12 weeks post-treatment
Title
Proportion of subjects with rash
Time Frame
At 12 weeks post-treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
The Health Care Authority For Baptist Health
City
Montgomery
State/Province
Alabama
ZIP/Postal Code
36116
Country
United States
Facility Name
Scripps Clinic
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Scpmg/ Kaiser Permanente Los Angeles Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
University Of Colorado Denver And Hospital
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Uf Hepatology Research At Ctrb
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Johns Hopkins Medical Institutions
City
Lutherville
State/Province
Maryland
ZIP/Postal Code
21093
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Washington University School Of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
North Shore-Long Island Jewish Health System
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
University Of North Carolina At Chapel Hill School Of Med
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Baylor College Of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Vamc
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Alamo Medical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Dean Clinic
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53715
Country
United States
Facility Name
Local Institution
City
Ciudad De Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
C1181ACH
Country
Argentina
Facility Name
Local Institution
City
Prov De Santa Fe
State/Province
Santa Fe
ZIP/Postal Code
2000
Country
Argentina
Facility Name
Local Institution
City
Buenos Aires
ZIP/Postal Code
1119
Country
Argentina
Facility Name
Local Institution
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Local Institution
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
Local Institution
City
Randwick
State/Province
New South Wales
ZIP/Postal Code
2070
Country
Australia
Facility Name
Local Institution
City
Fitzroy
State/Province
Queensland
ZIP/Postal Code
3065 VIC
Country
Australia
Facility Name
Local Institution
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Local Institution
City
Bedford Park, Sa
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
Facility Name
Local Institution
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
Local Institution
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
Local Institution
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Local Institution
City
Fremantle
State/Province
Western Australia
ZIP/Postal Code
6160
Country
Australia
Facility Name
Local Institution
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Local Institution
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6001
Country
Australia
Facility Name
Local Institution
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Local Institution
City
Linz
ZIP/Postal Code
4010
Country
Austria
Facility Name
Local Institution
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Local Institution
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Local Institution
City
Wien
ZIP/Postal Code
1160
Country
Austria
Facility Name
Gastrointestinal Research Institute (G.I.R.I.)
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 2K5
Country
Canada
Facility Name
Percuro Clinical Research Ltd
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8V 3P9
Country
Canada
Facility Name
Toronto General Hospital-University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
Facility Name
Toronto Liver Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6H 3M1
Country
Canada
Facility Name
Toronto Digestive Disease Associates, Inc.
City
Vaughan
State/Province
Ontario
ZIP/Postal Code
L4L 4Y7
Country
Canada
Facility Name
Clinique Medicale Lactuel
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4P9
Country
Canada
Facility Name
Jewish General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
Alpha-Recherche Clinique
City
Quebec
ZIP/Postal Code
G3K 2P8
Country
Canada
Facility Name
Local Institution
City
Clichy Cedex
ZIP/Postal Code
92118
Country
France
Facility Name
Local Institution
City
Creteil
ZIP/Postal Code
94000
Country
France
Facility Name
Local Institution
City
Lyon Cedex 04
ZIP/Postal Code
69317
Country
France
Facility Name
Local Institution
City
Marseille Cedex 08
ZIP/Postal Code
13285
Country
France
Facility Name
Local Institution
City
Paris Cedex 13
ZIP/Postal Code
75651
Country
France
Facility Name
Local Institution
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Local Institution
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Local Institution
City
Vandoeuvre Les Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Local Institution
City
Berlin
ZIP/Postal Code
12157
Country
Germany
Facility Name
Local Institution
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Local Institution
City
Bonn
ZIP/Postal Code
53105
Country
Germany
Facility Name
Local Institution
City
Essen
ZIP/Postal Code
45147
Country
Germany
Facility Name
Local Institution
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
Local Institution
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Local Institution
City
Hannover
ZIP/Postal Code
30623
Country
Germany
Facility Name
Local Institution
City
Muenchen
ZIP/Postal Code
81377
Country
Germany
Facility Name
Local Institution
City
Dublin
ZIP/Postal Code
DUBLIN 7
Country
Ireland
Facility Name
Local Institution
City
Dublin
ZIP/Postal Code
DUBLIN 8
Country
Ireland
Facility Name
Local Institution
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Local Institution
City
Jerusalem
ZIP/Postal Code
91031
Country
Israel
Facility Name
Local Institution
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Local Institution
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Local Institution
City
Tel Hashomer
ZIP/Postal Code
52621
Country
Israel
Facility Name
Local Institution
City
Zafed
ZIP/Postal Code
13110
Country
Israel
Facility Name
Local Institution
City
Messina
ZIP/Postal Code
98124
Country
Italy
Facility Name
Local Institution
City
Milano
ZIP/Postal Code
20121
Country
Italy
Facility Name
Local Institution
City
Roma
ZIP/Postal Code
00161
Country
Italy
Facility Name
Local Institution
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Local Institution
City
Busan
ZIP/Postal Code
602-715
Country
Korea, Republic of
Facility Name
Local Institution
City
Busan
ZIP/Postal Code
602-739
Country
Korea, Republic of
Facility Name
Local Institution
City
Busan
ZIP/Postal Code
614-735
Country
Korea, Republic of
Facility Name
Local Institution
City
Daegu
ZIP/Postal Code
700-721
Country
Korea, Republic of
Facility Name
Local Institution
City
Daegu
ZIP/Postal Code
705-703
Country
Korea, Republic of
Facility Name
Local Institution
City
Gyeonggi-do
ZIP/Postal Code
420-767
Country
Korea, Republic of
Facility Name
Local Institution
City
Gyeongsangnam-do
ZIP/Postal Code
626-770
Country
Korea, Republic of
Facility Name
Local Institution
City
Incheon
ZIP/Postal Code
400-711
Country
Korea, Republic of
Facility Name
Local Institution
City
Incheon
ZIP/Postal Code
403-720
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
110-774
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
Local Institution
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Local Institution
City
Leiden
ZIP/Postal Code
2300 RC
Country
Netherlands
Facility Name
Local Institution
City
Rotterdam
ZIP/Postal Code
3015 CE
Country
Netherlands
Facility Name
Local Institution
City
Auckland
ZIP/Postal Code
92024
Country
New Zealand
Facility Name
Local Institution
City
Hamilton
ZIP/Postal Code
3240
Country
New Zealand
Facility Name
Local Institution
City
Wellington
ZIP/Postal Code
6021
Country
New Zealand
Facility Name
Local Institution
City
Bialystok
ZIP/Postal Code
15-540
Country
Poland
Facility Name
Local Institution
City
Wroclaw
ZIP/Postal Code
50-349
Country
Poland
Facility Name
Local Institution
City
Chelyabinsk
ZIP/Postal Code
454052
Country
Russian Federation
Facility Name
Local Institution
City
Krasnoyarsk
ZIP/Postal Code
660049
Country
Russian Federation
Facility Name
Local Institution
City
Moscow
ZIP/Postal Code
111123
Country
Russian Federation
Facility Name
Local Institution
City
Moscow
ZIP/Postal Code
115446
Country
Russian Federation
Facility Name
Local Institution
City
Saint-Petersburg
ZIP/Postal Code
190103
Country
Russian Federation
Facility Name
Local Institution
City
Samara
ZIP/Postal Code
443077
Country
Russian Federation
Facility Name
Local Institution
City
Smolensk
ZIP/Postal Code
214018
Country
Russian Federation
Facility Name
Local Institution
City
Tyumen
ZIP/Postal Code
625026
Country
Russian Federation
Facility Name
Local Institution
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Facility Name
Local Institution
City
Barcelona
ZIP/Postal Code
08028
Country
Spain
Facility Name
Local Institution
City
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Local Institution
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
Local Institution
City
Taichung
ZIP/Postal Code
402
Country
Taiwan
Facility Name
Local Institution
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
Local Institution
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
Local Institution
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Local Institution
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Facility Name
Local Institution
City
London
State/Province
Greater London
ZIP/Postal Code
NW3 2QG,
Country
United Kingdom
Facility Name
Local Institution
City
London
State/Province
Greater London
ZIP/Postal Code
SW17 0QT
Country
United Kingdom
Facility Name
Local Institution
City
Manchester
State/Province
Greater Manchester
ZIP/Postal Code
M8 6RL
Country
United Kingdom
Facility Name
Local Institution
City
Glasgow
State/Province
Lanarkshire
ZIP/Postal Code
G12 0YN
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
27009831
Citation
Kao JH, Lee YJ, Heo J, Ahn SH, Lim YS, Peng CY, Chang TT, Torbeyns A, Hughes E, Bhore R, Noviello S. All-oral daclatasvir plus asunaprevir for chronic hepatitis C virus (HCV) genotype 1b infection: a sub-analysis in Asian patients from the HALLMARK DUAL study. Liver Int. 2016 Oct;36(10):1433-41. doi: 10.1111/liv.13128. Epub 2016 Apr 28.
Results Reference
derived
PubMed Identifier
26683763
Citation
Kao JH, Jensen DM, Manns MP, Jacobson I, Kumada H, Toyota J, Heo J, Yoffe B, Sievert W, Bessone F, Peng CY, Roberts SK, Lee YJ, Bhore R, Mendez P, Hughes E, Noviello S. Daclatasvir plus asunaprevir for HCV genotype 1b infection in patients with or without compensated cirrhosis: a pooled analysis. Liver Int. 2016 Jul;36(7):954-62. doi: 10.1111/liv.13049. Epub 2016 Jan 24.
Results Reference
derived
PubMed Identifier
25078304
Citation
Manns M, Pol S, Jacobson IM, Marcellin P, Gordon SC, Peng CY, Chang TT, Everson GT, Heo J, Gerken G, Yoffe B, Towner WJ, Bourliere M, Metivier S, Chu CJ, Sievert W, Bronowicki JP, Thabut D, Lee YJ, Kao JH, McPhee F, Kopit J, Mendez P, Linaberry M, Hughes E, Noviello S; HALLMARK-DUAL Study Team. All-oral daclatasvir plus asunaprevir for hepatitis C virus genotype 1b: a multinational, phase 3, multicohort study. Lancet. 2014 Nov 1;384(9954):1597-605. doi: 10.1016/S0140-6736(14)61059-X. Epub 2014 Jul 28. Erratum In: Lancet. 2014 Nov 1;384(9954):1576.
Results Reference
derived
Links:
URL
http://www.bms.com/studyconnect/Pages/home.aspx
Description
BMS clinical trial educational resource
Learn more about this trial
Phase III Hallmark DUAL: ASV+DCV (Nulls/Partials, Intolerants/Ineligibles. Naives)
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