Phase III Hallmark QUAD: ASV+DCV+Peg+Rib (Nulls/Partials)
Hallmark QUAD
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
2 other identifiers
interventional
398
15 countries
79
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started May 2012
79 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 5, 2012
CompletedFirst Posted
Study publicly available on registry
April 9, 2012
CompletedStudy Start
First participant enrolled
May 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedOctober 9, 2015
September 1, 2015
1.3 years
April 5, 2012
September 23, 2015
Conditions
Outcome Measures
Primary Outcomes (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
At 12 weeks post-treatment
Secondary Outcomes (5)
On-treatment safety, as measured by frequency of Serious Adverse Events (SAEs) and discontinuations due to Adverse Events (AEs) through the end of treatment
Through the end of treatment (maximum up to 24 weeks) plus 7 days
Proportion of subjects with SVR12 (HCV RNA < LOQ at post-treatment Week 12) by the rs12979860 single nucleotide polymorphisms (SNP) in the IL28 gene
At post-treatment Week 12
Proportion of subjects with HCV RNA undetectable
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
Proportion of subjects with HCV RNA < LOQ
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)
Proportion of patients with SVR12 (HCV RNA < LOQ at post-treatment Week 12) for HCV genotype 4 subjects
Post-treatment Week 12
Study Arms (1)
QUAD: Asunaprevir+Daclatasvir+Peg-interferon Alfa-2a+Ribavirin
EXPERIMENTALAsunaprevir: 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
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (79)
Alabama Liver & Digestive Specialists (Alds)
Montgomery, Alabama, 36116, United States
Scripps Clinic
La Jolla, California, 92037, United States
Scpmg/ Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027, United States
University Of Colorado Denver And Hospital
Aurora, Colorado, 80045, United States
South Denver Gastroenterology, Pc
Englewood, Colorado, 80113, United States
Mayo Clinic
Jacksonville, Florida, 32224, United States
University Of Miami Schiff Center For Liver Diseases
Miami, Florida, 33136, United States
University Of Chicago Medical Center
Chicago, Illinois, 60637-1432, United States
North Shore University Hospital
Manhasset, New York, 11030, United States
University Of North Carolina At Chapel Hill School Of Med
Chapel Hill, North Carolina, 27599-7584, United States
University Of Cincinnati
Cincinnati, Ohio, 45267, United States
Options Health Research, Llc
Tulsa, Oklahoma, 74104, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
University Of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Gastro One
Germantown, Tennessee, 38138, United States
Baylor College Of Medicine
Houston, Texas, 77030, United States
Texas Liver Institute
San Antonio, Texas, 78215, United States
Mcguire Dvamc
Richmond, Virginia, 23249, United States
Dean Clinic
Madison, Wisconsin, 53715, United States
Local Institution
Ciudad de Buenos Aires, Buenos Aires, C1121ABE, Argentina
Local Institution
Mar del Plata, Buenos Aires, 7600, Argentina
Local Institution
Prov. Buenos Aires, Buenos Aires, 1629, Argentina
Local Institution
Edmonton, Alberta, T6G 2B7, Canada
Local Institution
Vancouver, British Columbia, V6Z 2K5, Canada
Local Institution
Victoria, British Columbia, V8V 3P9, Canada
Local Institution
Toronto, Ontario, M6H 3M1, Canada
Local Institution
Montreal, Quebec, H2L 4P9, Canada
Local Institution
Aalborg, 9100, Denmark
Local Institution
Hvidovre, 2650, Denmark
Local Institution
Odense, 5000, Denmark
Local Institution
Créteil, 94000, France
Local Institution
Montpellier, 34295, France
Local Institution
Nice, 06202, France
Local Institution
Paris, 75571, France
Local Institution
Paris, 75679, France
Local Institution
Pessac, 33604, France
Local Institution
Berlin, 13353, Germany
Local Institution
Düsseldorf, 40237, Germany
Local Institution
Frankfurt, 60590, Germany
Local Institution
Freiburg im Breisgau, 79106, Germany
Local Institution
Hamburg, 20246, Germany
Local Institution
Heidelberg, 69120, Germany
Local Institution
Tübingen, 72076, Germany
Local Institution
Brescia, 25123, Italy
Local Institution
Cisanello (pisa), 56124, Italy
Local Institution
Milan, 20122, Italy
Local Institution
Palermo, 90127, Italy
Local Institution
Mexico City, Mexico City, 03720, Mexico
Local Institution
México, State of Mexico, 06700, Mexico
Local Institution
Amsterdam, 1105 AZ, Netherlands
Local Institution
Rotterdam, 3015 CE, Netherlands
Local Institution
Moscow, 117593, Russia
Local Institution
Moscow, 127015, Russia
Local Institution
Saint Petersburg, 194044, Russia
Local Institution
Stavropol, 355000, Russia
Local Institution
Tyumen, 625026, Russia
Local Institution
Bucheon-si, 420-767, South Korea
Local Institution
Busan, 602-715, South Korea
Local Institution
Busan, 602-739, South Korea
Local Institution
Busan, 614-735, South Korea
Local Institution
Daegu, 700-721, South Korea
Local Institution
Gyeongsangnam-do, 626-770, South Korea
Local Institution
Incheon, 400-711, South Korea
Local Institution
Incheon, 403-720, South Korea
Local Institution
Seoul, 120-752, South Korea
Local Institution
Seoul, 135-710, South Korea
Local Institution
Alcorcón, 28922, Spain
Local Institution
Barcelona, 08916, Spain
Local Institution
Madrid, 28029, Spain
Local Institution
Seville, 41014, Spain
Local Institution
Gvteborg, SE-41685, Sweden
Local Institution
Stockholm, 141 86, Sweden
Local Institution
Bern, 3010, Switzerland
Local Institution
Lausanne, 1011, Switzerland
Local Institution
Chiayi City, 600, Taiwan
Local Institution
Kaohsiung City, 807, Taiwan
Local Institution
Taichung, 40705, Taiwan
Local Institution
Taipei, 11217, Taiwan
Related Publications (1)
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.
PMID: 25703086DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 5, 2012
First Posted
April 9, 2012
Study Start
May 1, 2012
Primary Completion
September 1, 2013
Study Completion
December 1, 2013
Last Updated
October 9, 2015
Record last verified: 2015-09