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

• Status: Completed
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Collaborator: Janssen Research & Development, LLC
• Treatments: Ribavirin; Simeprevir

Criteria

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