Study of Daclatasvir (BMS-790052) and Simeprevir (TMC435) in Patients With Genotype 1 Chronic Hepatitis C Virus



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

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A Phase 2, Open-Label Study of Daclatasvir (BMS-790052) and TMC435 in Combination With or Without Ribavirin (RBV) For Treatment-Naive Subjects or Null Responders to Prior Peginterferon Alfa (PegIFN)/RBV Therapy With Genotype 1 Chronic Hepatitis C

The purpose of this study is to assess the safety and efficacy of daclatasvir and simeprevir
with and without ribavirin for genotype 1 chronic hepatitis C virus infection in patients
who are treatment-naive or null responders to previous pegylated interferon/ribavirin
therapy.


Key Inclusion Criteria:

- Hepatitis C virus (HCV) genotype 1a or 1b

- Males and females, ≥18 years of age

- HCV RNA ≥10,000 IU/mL

- Participants with compensated cirrhosis are permitted

- Advanced fibrosis (F3/F4) is capped at approximately 35% of the total treated
population with a minimum of 20% F4 patients

- If no cirrhosis, a liver biopsy within 3 years prior to enrollment

- If cirrhosis is present, any prior liver biopsy

Key Exclusion Criteria:

- Liver or any other transplant (other than cornea and hair)

- Evidence of a medical condition contributing to chronic liver disease other than HCV
infection

- Current or known history of cancer, (except in situ carcinoma of the cervix or
adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior
to enrollment

- Evidence of decompensated liver disease including, but not limited to, radiologic
criteria, a history or presence of ascites, bleeding varices, or hepatic
encephalopathy

- Patients infected with HIV or hepatitis B virus

- Gastrointestinal disease impacting absorption of study drug

- Uncontrolled diabetes or hypertension

- Prior exposure to an HCV direct-acting agent

- Any criteria that would exclude the patient from receiving ribavirin

- Absolute neutrophil count <1.5*1,000,000,000 cells/L (<1.2*1,000,000,000 cells/L for
Black/African Americans)

- Platelets <90*1,000,000,000 cells/L

- Hemoglobin <12 g/dL for females, <13 g/dL for males

- Alanine aminotransferase ≥5*upper limit of normal

- In patients without cirrhosis, total bilirubin ≥2 mg/dL unless patient has a
documented history of Gilbert's disease

- In patients with cirrhosis, total bilirubin o ≥1.5 mg/dL

- International normalized ratio ≥1.7

- QTcF or QTcB >500 mSec

- Creatinine clearance ≤50 mL/min

- Alpha fetoprotein (AFP) >100 ng/mL OR

- AFP ≥50 ng/mL and ≤100 ng/mL requiring liver ultrasound

- Albumin <3.5 g/dL
We found this trial at
8
sites
Arlington, Texas 76012
348
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Arlington, TX
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425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
642
mi
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Indianapolis, IN
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Buenos Aires,
5602
mi
from
Buenos Aires,
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Fairfax, Virginia 22031
1114
mi
from
Fairfax, VA
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1101 East 33rd Street
Lutherville, Maryland 21093
1149
mi
from
Lutherville, MD
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Nashville, Tennessee 37205
615
mi
from
Nashville, TN
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1001 Potrero Ave
San Francisco, California 94110
(415) 206-8000
San Francisco General Hospital San Francisco General Hospital and Trauma Center (SFGH) is an essential...
1339
mi
from
San Francisco, CA
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San Francisco, California 94115
1340
mi
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San Francisco, CA
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