EUCTR2012-003738-18-PLActive, not recruitingNot Applicable
A Randomized, Open-Labeled Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT-267 and ABT-333 Co-administered with Ribavirin Compared to Telaprevir Co-administered with Pegylated Interferon a-2a and Ribavirin in Treatment-Experienced Adults with Chronic Hepatitis C Genotype 1 Virus Infection (MALACHITE II)
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 150
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Males or females 18 to 65 years old, inclusive
- •Females must be post-menopausal for more than 2 years or surgically sterile or practicing abstinence/specific forms of birth control
- •Chronic hepatitis C, genotype 1-infection
- •Subject must have documentation of adherence to a prior pegIFN/RBV combination therapy and meet one of the protocol definitions for treatment failure: null responder, partial responder, relapser
- •No evidence of liver cirhhosis
- •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 150
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •Positive screen for drugs or alcohol
- •Significant sensitivity to any drug
- •Use of contraindicated medications within 2 weeks of dosing
- •Abnormal laboratory tests
- •Positive hepatitis B surface antigen and anti-Human Immunodeficiency Virus antibody
Investigators
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