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



Status:Completed
Conditions:Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:May 2012
End Date:December 2013

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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.

- ASV = Asunaprevir (BMS-650032)

- DCV = Daclatasvir (BMS-790052)

- Peg = Peg-interferon Alfa-2a (PegIFN)

- Rib = Ribavirin (RBV)

Inclusion Criteria:

- 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)

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

- 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
We found this trial at
21
sites
San Antonio, Texas 78215
1136
mi
from 43215
San Antonio, TX
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
991
mi
from 43215
Houston, TX
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4201 Belfort Road
Jacksonville, Florida 32216
(408) 293-2336
Mayo Clinic Mayo Clinic's campus in Arizona provides medical care for thousands of people from...
675
mi
from 43215
Jacksonville, FL
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300 Community Drive
Manhasset, New York 11030
(516) 562-0100
North Shore University Hospital North Shore-LIJ Health System includes 16 award-winning hospitals and nearly 400...
493
mi
from 43215
Manhasset, NY
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
2026
mi
from 43215
Portland, OR
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1154
mi
from 43215
Aurora, CO
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353
mi
from 43215
Chapel Hill, NC
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5841 S Maryland Ave
Chicago, Illinois 60637
(773) 702-1000
University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
270
mi
from 43215
Chicago, IL
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2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
98
mi
from 43215
Cincinnati, OH
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Ciudad De Buenos Aires, Buenos Aires
5386
mi
from 43215
Ciudad De Buenos Aires,
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Englewood, Colorado 80113
1163
mi
from 43215
Englewood, CO
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Germantown, Tennessee 38138
501
mi
from 43215
Germantown, TN
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10666 N Torrey Pines Rd
La Jolla, California 92037
(858) 554-9100
Scripps Clinic Scripps Clinic in Torrey Pines has been providing exceptional medical care to people...
1953
mi
from 43215
La Jolla, CA
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1972
mi
from 43215
Los Angeles, CA
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Madison, Wisconsin 53715
393
mi
from 43215
Madison, WI
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992
mi
from 43215
Miami, FL
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558
mi
from 43215
Montgomery, AL
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
414
mi
from 43215
Philadelphia, PA
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1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
416
mi
from 43215
Philadelphia, PA
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Richmond, Virginia 23249
342
mi
from 43215
Richmond, VA
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Tulsa, Oklahoma 74137
752
mi
from 43215
Tulsa, OK
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