Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bristol-Myers Squibb
With
Janssen Research & Development, LLC
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Study of Daclatasvir (BMS-790052) and Simeprevir (TMC435) in Patients With Genotype 1 Chronic Hepatitis C Virus
