TOPAZ II

Protocol: 
M14-222
Phase: 
III

A Phase 3b study to evaluate the long-term outcomes following treatment with Abbvie DAAs and with or without Ribavirin (RBV) in adults with genotype 1 Chronic Hepatitis C Virus (HCV) Infection

The purpose of this study is to evaluate Long-term Outcomes following treatment with ABT-450/r/ABT-267, ABT-333 with or without RBV in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection.

Trial Website: https://clinicaltrials.gov/show/NCT02167945

Are you Eligible? (Inclusion Criteria)

Inclusion Criteria:

  1. Females must be post-menopausal for more than 2 years or surgically sterile or practicing specific forms of birth control
  2. Chronic hepatitis C, genotype 1-infection (HCV RNA level greater than 1,000 IU/mL at screening)
  3. HCV genotype 1 infection per screening laboratory result

Exclusion Criteria:

  1. Use of contraindicated medications within 2 weeks of dosing
  2. Abnormal laboratory tests
  3. Positive hepatitis B surface antigen and anti-Human Immunodeficiency Virus Antibody
  4. Clinical history of liver decompensation
  5. Presence of hepatocellular carcinoma at screening

Specialty Area(s)

Trial Location

NYP/Columbia
New York, NY 10032
United States