A Randomized, Open-Label Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT-267 and ABT-333 Co-administered with and without Ribavirin Compared to Telaprevir Co-administered with Pegylated Interferon a-2a and Ribavirin in Treatment-Naïve Adults with Chronic Hepatitis C Genotype 1 Virus Infection (MALACHITE I)

AbbVie Deutschland GmbH & Co. KG0 sites314 target enrollmentStarted: May 7, 2013Last updated: March 14, 2016

Conditions

Drugs

Trial Snapshot

No summary available.

•1. Male or female and age is between 18 and 65 years, inclusive, at time of Screening. Females must be post-menopausal for more than 2 years or surgically sterile or practicing abstinence/specific forms of birth control
•2. Subject has never received antiviral treatment for hepatitis C infection.
•3. Chronic HCV Genotype-1 infection prior to study enrollment.
•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 314
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol.
•2. Positive screen for drugs or alcohol.
•3. Positive test result for Hepatitis B surface antigen (HBsAg) or anti-Human Immunodeficiency virus antibody (HIV Ab).
•4. Females who are pregnant or plan to become pregnant, or breastfeeding
•5. Any current or past clinical evidence of cirrhosis
•6. Screening laboratory analyses that showing abnormal laboratory results
•7. Use of contraindicated medications within 2 weeks of dosing and subject with contraindication for Telaprevir, PegIFN and RBV

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