TOPAZ-I
Brief summary
The purpose of this study is to evaluate Long-term outcomes following treatment with a combination of 2 active drugs with or without RBV in adults with genotype 1 Chronic Hepatitis C Virus (HCV) infection.
Interventional study
- 1
- 2
- 3
- 4
Age:
From 18 Years to 99 Years.
Inclusion Criteria:
1. Males and females at least 18 years old at screening
2. Females must be post-menopausal for more than 2 years or surgically sterile or
practicing acceptable forms of birth control
3. Chronic hepatitis C, genotype 1 infection
4. Males must be surgically sterile or agree to practice acceptable forms of birth
control
5. Screening laboratory result indicating HCV genotype 1 infection
Exclusion Criteria:
1. Use of contraindicated medications within 2 weeks of dosing
2. Abnormal laboratory tests
3. Current or past clinical evidence of Child-Pugh B or C classification or history of
liver decompensation
4. Confirmed presence of hepatocellular carcinoma
5. History of solid organ transplant
