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Hepatitis C VirusPhase 3Hallmark DUALNCT01581203

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

A Phase 3 study testing Asunaprevir (ASV), Daclatasvir (DCV) and Pegylated-interferon alfa 2a (PegIFN) in people with Hepatitis C Virus, run by Bristol-Myers Squibb at 116 sites in 18 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatitis C Virus
What is being tested?
Asunaprevir (ASV), Daclatasvir (DCV) and Pegylated-interferon alfa 2a (PegIFN)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
748 participants
Where
116 sitesin 18 countries
Study dates
May 2012to Sep 2014
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

116 sites in 18 countries.

116 sites in 18 countries

United States18 sites

  • University Of Colorado Denver And Hospital

    Aurora, Colorado, 80045

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • University Of North Carolina At Chapel Hill School Of Med

    Chapel Hill, North Carolina, 27599

  • Carolinas Medical Center

    Charlotte, North Carolina, 28204

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Uf Hepatology Research At Ctrb

    Gainesville, Florida, 32610

  • Baylor College Of Medicine

    Houston, Texas, 77030

  • Vamc

    Houston, Texas, 77030

  • Scripps Clinic

    La Jolla, California, 92037

  • Scpmg/ Kaiser Permanente Los Angeles Medical Center

    Los Angeles, California, 90027

  • Johns Hopkins Medical Institutions

    Lutherville, Maryland, 21093

  • Dean Clinic

    Madison, Wisconsin, 53715

  • North Shore-Long Island Jewish Health System

    Manhasset, New York, 11030

  • The Health Care Authority For Baptist Health

    Montgomery, Alabama, 36116

  • Weill Cornell Medical College

    New York, New York, 10021

  • Alamo Medical Research

    San Antonio, Texas, 78215

  • Washington University School Of Medicine

    St Louis, Missouri, 63110

Other trials in United States

South Korea13 sites

  • Local Institution

    Busan, 602-715

  • Local Institution

    Busan, 602-739

  • Local Institution

    Busan, 614-735

  • Local Institution

    Daegu, 700-721

  • Local Institution

    Daegu, 705-703

  • Local Institution

    Gyeonggi-do, 420-767

  • Local Institution

    Gyeongsangnam-do, 626-770

  • Local Institution

    Incheon, 400-711

  • Local Institution

    Incheon, 403-720

  • Local Institution

    Seoul, 110-774

  • Local Institution

    Seoul, 120-752

  • Local Institution

    Seoul, 135-710

  • Local Institution

    Seoul, 138-736

Other trials in South Korea

Australia12 sites

  • Local Institution

    Adelaide, South Australia, 5000

  • Local Institution

    Bedford Park, Sa, South Australia, 5042

  • Local Institution

    Clayton, Victoria, 3168

  • Local Institution

    Darlinghurst, New South Wales, 2010

  • Local Institution

    Fitzroy, Queensland, 3065 VIC

  • Local Institution

    Fremantle, Western Australia, 6160

  • Local Institution

    Heidelberg, Victoria, 3084

  • Local Institution

    Kogarah, New South Wales, 2217

  • Local Institution

    Melbourne, Victoria, 3004

  • Local Institution

    Nedlands, Western Australia, 6009

  • Local Institution

    Perth, Western Australia, 6001

  • Local Institution

    Randwick, New South Wales, 2070

Other trials in Australia

Canada8 sites

  • Clinique Medicale Lactuel

    Montreal, Quebec, H2L 4P9

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2

  • Alpha-Recherche Clinique

    Québec, Quebec, G3K 2P8

  • Toronto General Hospital-University Health Network

    Toronto, Ontario, M5G 2C4

  • Toronto Liver Centre

    Toronto, Ontario, M6H 3M1

  • Gastrointestinal Research Institute (G.I.R.I.)

    Vancouver, British Columbia, V6Z 2K5

  • Toronto Digestive Disease Associates, Inc.

    Vaughan, Ontario, L4L 4Y7

  • Percuro Clinical Research Ltd

    Victoria, British Columbia, V8V 3P9

Other trials in Canada

France8 sites

  • Local Institution

    Clichy, 92118

  • Local Institution

    Créteil, 94000

  • Local Institution

    Lyon, 69317

  • Local Institution

    Marseille, 13285

  • Local Institution

    Paris, 75014

  • Local Institution

    Paris, 75651

  • Local Institution

    Toulouse, 31059

  • Local Institution

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Germany8 sites

  • Local Institution

    Berlin, 12157

  • Local Institution

    Berlin, 13353

  • Local Institution

    Bonn, 53105

  • Local Institution

    Essen, 45147

  • Local Institution

    Frankfurt, 60590

  • Local Institution

    Hamburg, 20246

  • Local Institution

    Hanover, 30623

  • Local Institution

    München, 81377

Other trials in Germany

Russia8 sites

  • Local Institution

    Chelyabinsk, 454052

  • Local Institution

    Krasnoyarsk, 660049

  • Local Institution

    Moscow, 111123

  • Local Institution

    Moscow, 115446

  • Local Institution

    Saint Petersburg, 190103

  • Local Institution

    Samara, 443077

  • Local Institution

    Smolensk, 214018

  • Local Institution

    Tyumen, 625026

Other trials in Russia

Israel6 sites

  • Local Institution

    Haifa, 31096

  • Local Institution

    Jerusalem, 91031

  • Local Institution

    Jerusalem, 91120

  • Local Institution

    Tel Aviv, 64239

  • Local Institution

    Tel HaShomer, 52621

  • Local Institution

    Zafed, 13110

Other trials in Israel

Austria5 sites

  • Local Institution

    Graz, 8036

  • Local Institution

    Linz, 4010

  • Local Institution

    Salzburg, 5020

  • Local Institution

    Vienna, 1090

  • Local Institution

    Vienna, 1160

Other trials in Austria

Taiwan5 sites

  • Local Institution

    Taichung, 402

  • Local Institution

    Taichung, 40447

  • Local Institution

    Tainan, 704

  • Local Institution

    Taipei, 100

  • Local Institution

    Taipei, 112

Other trials in Taiwan

Italy4 sites

  • Local Institution

    Messina, 98124

  • Local Institution

    Milan, 20121

  • Local Institution

    Roma, 00161

  • Local Institution

    Torino, 10126

Other trials in Italy

Spain4 sites

  • Local Institution

    Alicante, 03010

  • Local Institution

    Barcelona, 08028

  • Local Institution

    Madrid, 28222

  • Local Institution

    Valencia, 46009

Other trials in Spain

United Kingdom4 sites

  • Local Institution

    Glasgow, Lanarkshire, G12 0YN

  • Local Institution

    London, Greater London, NW3 2QG,

  • Local Institution

    London, Greater London, SW17 0QT

  • Local Institution

    Manchester, Greater Manchester, M8 6RL

Other trials in United Kingdom

Argentina3 sites

  • Local Institution

    Buenos Aires, Buenos Aires, 1119

  • Local Institution

    Ciudad de Buenos Aires, Buenos Aires, C1181ACH

  • Local Institution

    Prov de Santa Fe, Santa Fe Province, 2000

Other trials in Argentina

Netherlands3 sites

  • Local Institution

    Amsterdam, 1105 AZ

  • Local Institution

    Leiden, 2300 RC

  • Local Institution

    Rotterdam, 3015 CE

Other trials in Netherlands

New Zealand3 sites

  • Local Institution

    Auckland, 92024

  • Local Institution

    Hamilton, 3240

  • Local Institution

    Wellington, 6021

Other trials in New Zealand

Ireland2 sites

  • Local Institution

    Dublin, Dublin, DUBLIN 7

  • Local Institution

    Dublin, Dublin, DUBLIN 8

Other trials in Ireland

Poland2 sites

  • Local Institution

    Bialystok, 15-540

  • Local Institution

    Wroclaw, 50-349

Other trials in Poland

About this study

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

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.

Read the 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

Being tested
Asunaprevir (ASV), Daclatasvir (DCV), Pegylated-interferon alfa 2a (PegIFN), Ribavirin (RBV)
Medical subject headings
Hepatitis C

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Asunaprevir (ASV)Drug

    Also called BMS-650032

  • Daclatasvir (DCV)Drug

    Also called BMS-790052

  • Pegylated-interferon alfa 2a (PegIFN)Drug

    Also called Pegasys

  • Ribavirin (RBV)Drug

    Also called Copegus

Study groups in NCT01581203
Study groupRoleWhat they receive
Arm 1: Null or Partial Responder to P/R (ASV + DCV)ExperimentalAsunaprevir 100 mg Capsules by mouth, Twice daily for 24 Weeks Daclatasvir 60 mg Tablet by mouth, Once daily for 24 Weeks
Receives: Drug: Asunaprevir (ASV); Drug: Daclatasvir (DCV)
Arm 2: Intolerant to or Ineligible for P/R (ASV + DCV)ExperimentalAsunaprevir 100 mg Capsules by mouth, Twice daily for 24 Weeks Daclatasvir 60 mg Tablet by mouth, Once daily for 24 Weeks
Receives: Drug: Asunaprevir (ASV); Drug: Daclatasvir (DCV)
Arm 3: Treatment naive (ASV + DCV)Experimental[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
Receives: Drug: Asunaprevir (ASV); Drug: Daclatasvir (DCV); Drug: Pegylated-interferon alfa 2a (PegIFN); Drug: Ribavirin (RBV)
Arm 4: Null or Partial Responder to P/R (ASV + DCV) 24/48 weekExperimentalSubjects 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
Receives: Drug: Asunaprevir (ASV); Drug: Daclatasvir (DCV); Drug: Pegylated-interferon alfa 2a (PegIFN); Drug: Ribavirin (RBV)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: At 12 weeks post-treatment

Secondary outcomes (8)

  1. 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

    Measured: Post-treatment Week 12

  2. On treatment safety, as measured by frequency of Serious Adverse Events (SAEs) and discontinuations due to Adverse Events (AEs)

    Measured: End of Treatment (up to 48 weeks) plus 7 days

  3. Differences in rates of selected grade 3-4 laboratory abnormalities during the first 12 weeks between treatments (ASV + DCV vs PBO) for naive subjects

    Measured: Up to first 12 weeks

  4. 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

    Measured: Post-treatment Week 12

  5. Proportion of genotype 1b subjects with HCV RNA undetectable

    eRVR = Extended rapid virologic response, EOT = End of treatment

    Measured: 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

  6. Proportion of genotypes 1b subjects with HCV RNA < LOQ

    Measured: 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

  7. Proportion of subjects with anemia

    Measured: At 12 weeks post-treatment

  8. Proportion of subjects with rash

    Measured: At 12 weeks post-treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2012 (estimated)
  2. Study startMay 2012
  3. Primary completionOct 2013
  4. Study completionSep 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
748 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01581203
Sponsor's protocol ID
AI447-028
Other IDs
2011-005446-35
Acronym
Hallmark DUAL
Status last verified
Sep 2015
First submitted
18 Apr 2012
Last updated
9 Oct 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 27009831

  • 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.

    PubMed 26683763

  • 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.

    PubMed 25078304

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Asunaprevir (ASV), Daclatasvir (DCV) and Pegylated-interferon alfa 2a (PegIFN) in people with Hepatitis C Virus, run by Bristol-Myers Squibb at 116 sites in 18 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 116 sites in United States, South Korea, Australia, Canada, France and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01581203, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2015.

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