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 |
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.
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
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Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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San Francisco General Hospital San Francisco General Hospital and Trauma Center (SFGH) is an essential...
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