EUCTR2014-001022-14-GBActive, not recruitingNot Applicable
An Open-Label, Multicenter Study to Evaluate Long-Term Outcomes with ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection - TOPAZ-I
AbbVie Deutschland GmbH & Co. KG0 sites1,650 target enrollmentStarted: September 10, 2014Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 1,650
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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. Males must be surgically sterile or agree to practice acceptable forms of birth control
- •4. Chronic HCV infection prior to study enrollment.
- •5. Screening laboratory result indicating HCV genotype 1 infection.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1470
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 180
Exclusion Criteria
- •1. Use of contraindicated medication 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
Investigators
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