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Hepatitis C VirusPhase 3Hallmark QUADNCT01573351

Phase III Hallmark QUAD: ASV+DCV+Peg+Rib (Nulls/Partials)

A Phase 3 study testing Asunaprevir, Daclatasvir and Peg-interferon Alfa-2a in people with Hepatitis C Virus, run by Bristol-Myers Squibb at 79 sites in 15 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 assess 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. 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, Daclatasvir and Peg-interferon Alfa-2a
Could I receive a placebo?
No, everyone receives an active treatment
How many people
398 participants
Where
79 sitesin 15 countries
Study dates
May 2012to Dec 2013
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 1 or 4 who previously failed treatment with Peginterferon alfa-2a or peginterferon alfa-2b and Ribavirin (P/R), classified as previous null and partial responders based on previous therapy
  • 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
  • Total bilirubin ≥ 34 μmol/L (or ≥ 2 mg/dL) unless subject has a documented history of Gilbert's disease
Show all 13Show fewer
  • Alanine aminotransferase (ALT) ≥ 5x Upper limit of normal (ULN)
  • Albumin < 3.5 g/dL (35 g/L)
  • Alpha Fetoprotein (AFP) > 100 ng/mL (>82.6 IU/mL) or ≥ 50 and ≤ 100 ng/mL requires a liver ultrasound and subjects with findings suspicious of Hepatocellular carcinoma (HCC) are excluded
  • Absolute neutrophil count (ANC) < 1.5 x 1000,000,000 cells/L (< 1.2 x 1000,000,000 cells/L for Black/African-Americans)
  • Platelets < 90 x 1000,000,000 cells/L
  • Hemoglobin < 12 g/dL for females or < 13 g/dL for males
  • Any criteria that would exclude the subject from receiving P/R

Trial locations and contacts

79 sites in 15 countries.

79 sites in 15 countries

United States20 sites

  • University Of Colorado Denver And Hospital

    Aurora, Colorado, 80045

  • University Of North Carolina At Chapel Hill School Of Med

    Chapel Hill, North Carolina, 27599-7584

  • University Of Chicago Medical Center

    Chicago, Illinois, 60637-1432

  • University Of Cincinnati

    Cincinnati, Ohio, 45267

  • South Denver Gastroenterology, Pc

    Englewood, Colorado, 80113

  • Gastro One

    Germantown, Tennessee, 38138

  • Baylor College Of Medicine

    Houston, Texas, 77030

  • Mayo Clinic

    Jacksonville, Florida, 32224

  • Scripps Clinic

    La Jolla, California, 92037

  • Scpmg/ Kaiser Permanente Los Angeles Medical Center

    Los Angeles, California, 90027

  • Dean Clinic

    Madison, Wisconsin, 53715

  • North Shore University Hospital

    Manhasset, New York, 11030

  • University Of Miami Schiff Center For Liver Diseases

    Miami, Florida, 33136

  • Alabama Liver & Digestive Specialists (Alds)

    Montgomery, Alabama, 36116

  • University Of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Oregon Health & Science University

    Portland, Oregon, 97239

  • Mcguire Dvamc

    Richmond, Virginia, 23249

  • Texas Liver Institute

    San Antonio, Texas, 78215

  • Options Health Research, Llc

    Tulsa, Oklahoma, 74104

Other trials in United States

South Korea10 sites

  • Local Institution

    Bucheon-si, 420-767

  • Local Institution

    Busan, 602-715

  • Local Institution

    Busan, 602-739

  • Local Institution

    Busan, 614-735

  • Local Institution

    Daegu, 700-721

  • Local Institution

    Gyeongsangnam-do, 626-770

  • Local Institution

    Incheon, 400-711

  • Local Institution

    Incheon, 403-720

  • Local Institution

    Seoul, 120-752

  • Local Institution

    Seoul, 135-710

Other trials in South Korea

Germany7 sites

  • Local Institution

    Berlin, 13353

  • Local Institution

    Düsseldorf, 40237

  • Local Institution

    Frankfurt, 60590

  • Local Institution

    Freiburg im Breisgau, 79106

  • Local Institution

    Hamburg, 20246

  • Local Institution

    Heidelberg, 69120

  • Local Institution

    Tübingen, 72076

Other trials in Germany

France6 sites

  • Local Institution

    Créteil, 94000

  • Local Institution

    Montpellier, 34295

  • Local Institution

    Nice, 06202

  • Local Institution

    Paris, 75571

  • Local Institution

    Paris, 75679

  • Local Institution

    Pessac, 33604

Other trials in France

Canada5 sites

  • Local Institution

    Edmonton, Alberta, T6G 2B7

  • Local Institution

    Montreal, Quebec, H2L 4P9

  • Local Institution

    Toronto, Ontario, M6H 3M1

  • Local Institution

    Vancouver, British Columbia, V6Z 2K5

  • Local Institution

    Victoria, British Columbia, V8V 3P9

Other trials in Canada

Russia5 sites

  • Local Institution

    Moscow, 117593

  • Local Institution

    Moscow, 127015

  • Local Institution

    Saint Petersburg, 194044

  • Local Institution

    Stavropol, 355000

  • Local Institution

    Tyumen, 625026

Other trials in Russia

Italy4 sites

  • Local Institution

    Brescia, 25123

  • Local Institution

    Cisanello (pisa), 56124

  • Local Institution

    Milan, 20122

  • Local Institution

    Palermo, 90127

Other trials in Italy

Spain4 sites

  • Local Institution

    Alcorcón, 28922

  • Local Institution

    Barcelona, 08916

  • Local Institution

    Madrid, 28029

  • Local Institution

    Seville, 41014

Other trials in Spain

Taiwan4 sites

  • Local Institution

    Chiayi City, 600

  • Local Institution

    Kaohsiung City, 807

  • Local Institution

    Taichung, 40705

  • Local Institution

    Taipei, 11217

Other trials in Taiwan

Argentina3 sites

  • Local Institution

    Ciudad de Buenos Aires, Buenos Aires, C1121ABE

  • Local Institution

    Mar del Plata, Buenos Aires, 7600

  • Local Institution

    Prov. Buenos Aires, Buenos Aires, 1629

Other trials in Argentina

Denmark3 sites

  • Local Institution

    Aalborg, 9100

  • Local Institution

    Hvidovre, 2650

  • Local Institution

    Odense, 5000

Other trials in Denmark

Mexico2 sites

  • Local Institution

    México, State of Mexico, 06700

  • Local Institution

    Mexico City, Mexico City, 03720

Other trials in Mexico

Netherlands2 sites

  • Local Institution

    Amsterdam, 1105 AZ

  • Local Institution

    Rotterdam, 3015 CE

Other trials in Netherlands

Sweden2 sites

  • Local Institution

    Gvteborg, SE-41685

  • Local Institution

    Stockholm, 141 86

Other trials in Sweden

Switzerland2 sites

  • Local Institution

    Bern, 3010

  • Local Institution

    Lausanne, 1011

Other trials in Switzerland

About this study

Official title: A Phase 3, Open-Label Study With Asunaprevir and Daclatasvir Plus Peginterferon Alfa-2a (Pegasys) and Ribavirin (Copegus) (P/R) (QUAD) for Subjects Who Are Null or Partial Responders to Peginterferon Alfa 2a or 2b Plus Ribavirin With Chronic Hepatitis C Genotypes 1 or 4 Infection

The purpose of this study is to assess 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.

Read the detailed description
  • ASV = Asunaprevir (BMS-650032)
  • DCV = Daclatasvir (BMS-790052)
  • Peg = Peg-interferon Alfa-2a (PegIFN)
  • Rib = Ribavirin (RBV)
Being tested
Asunaprevir, Daclatasvir, Peg-interferon Alfa-2a, Ribavirin
Medical subject headings
Hepatitis C

What participants receive

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

  • AsunaprevirDrug

    Also called BMS-650032

  • DaclatasvirDrug

    Also called BMS-790052

  • Peg-interferon Alfa-2aDrug

    Also called Pegasys®

  • RibavirinDrug

    Also called Copegus®

Study groups in NCT01573351
Study groupRoleWhat they receive
QUAD: Asunaprevir+Daclatasvir+Peg-interferon Alfa-2a+RibavirinExperimentalAsunaprevir: Capsule, Oral, 100 mg, Twice daily, 24 weeks Daclatasvir: Tablet, Oral, 60 mg, Once daily, 24 weeks Peg-interferon Alfa-2a: Injection, subcutaneous (SC), 180 mcg/0.5 mL, Once weekly, 24 weeks Ribavirin: Tablet, Oral, 1000 mg/1200 mg (total daily dose), 24 weeks
Receives: Drug: Asunaprevir; Drug: Daclatasvir; Drug: Peg-interferon Alfa-2a; Drug: Ribavirin

What is being measured

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

  1. Proportion of genotype 1 subjects with SVR12, defined as HCV RNA < LOQ at post-treatment Week 12, for all subjects infected with HCV genotype 1

    Measured: At 12 weeks post-treatment

Secondary outcomes (5)

  1. On-treatment safety, as measured by frequency of Serious Adverse Events (SAEs) and discontinuations due to Adverse Events (AEs) through the end of treatment

    Measured: Through the end of treatment (maximum up to 24 weeks) plus 7 days

  2. Proportion of subjects with SVR12 (HCV RNA < LOQ at post-treatment Week 12) by the rs12979860 single nucleotide polymorphisms (SNP) in the IL28 gene

    Measured: At post-treatment Week 12

  3. Proportion of subjects with HCV RNA undetectable

    Measured: Weeks 1, 2, 4, 6, 8 and 12; at both Weeks 4 and 12 [Extended rapid virologic response (eRVR)], end of treatment (up to 24 weeks), post-treatment Week 12 or post-treatment Week 24

  4. Proportion of subjects with HCV RNA < LOQ

    Measured: Weeks 1, 2, 4, 6, 8 and 12; at both Weeks 4 and 12, end of treatment (up to 24 weeks), post-treatment Week 24 (SVR24)

  5. Proportion of patients with SVR12 (HCV RNA < LOQ at post-treatment Week 12) for HCV genotype 4 subjects

    Measured: Post-treatment Week 12

Timeline

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

  1. First posted9 Apr 2012 (estimated)
  2. Study startMay 2012
  3. Primary completionSep 2013
  4. Study completionDec 2013

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
398 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01573351
Sponsor's protocol ID
AI447-029
Other IDs
2011-005422-21
Acronym
Hallmark QUAD
Status last verified
Sep 2015
First submitted
5 Apr 2012
Last updated
9 Oct 2015
Results posted
No
Data monitoring committee
No

Publications

  • Jensen D, Sherman KE, Hezode C, Pol S, Zeuzem S, de Ledinghen V, Tran A, Elkhashab M, Younes ZH, Kugelmas M, Mauss S, Everson G, Luketic V, Vierling J, Serfaty L, Brunetto M, Heo J, Bernstein D, McPhee F, Hennicken D, Mendez P, Hughes E, Noviello S; HALLMARK-QUAD Study Team. Daclatasvir and asunaprevir plus peginterferon alfa and ribavirin in HCV genotype 1 or 4 non-responders. J Hepatol. 2015 Jul;63(1):30-7. doi: 10.1016/j.jhep.2015.02.018. Epub 2015 Feb 19.

    PubMed 25703086

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Asunaprevir, Daclatasvir and Peg-interferon Alfa-2a in people with Hepatitis C Virus, run by Bristol-Myers Squibb at 79 sites in 15 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 13 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 79 sites in United States, South Korea, Germany, France, Canada and 10 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 genotype 1 subjects with SVR12, defined as HCV RNA < LOQ at post-treatment Week 12, for all subjects infected with HCV genotype 1 (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 NCT01573351, which also lists 1 linked publication.

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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