Chronic Hepatitis C Virus infection
Conditions
Interventions
investigational material(s)
Generic name etc : ABT-450, ABT-267, Ritonavir
INN of investigational material : Not available
Therapeutic category code : 625 Anti-virus agents
Dosage and Administration f
Sponsors
AbbVie GK
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Male or female between the age 18 and 75 years, inclusive. -Previously received Pegylated interferon alpha-2a/Ribavirin. -Chronic hepatitis C virus infection. -Plasma hepatitis C virus ribonucleic acid level greater than 10,000 International Units/milliliter. -Voluntarily sign an informed consent.
Exclusion criteria
Exclusion criteria: -Histry of severe, life-threatening sensitivity to any drug. -Females who are pregnant or plan to become pregnant, or breastfeeding. -Recent histry of drug or alcohol abuse. -Positive test result for hepatitis B surface antigen or anti-Human immunodeficiency virus antibodies. -Any current or past clinical evidence of cirrhosis. -Previous use of any investigational or commerciallyavailable anti-Hepatitis C virus agent other than Pegylated interferon alpha-2a and Ribavirin, including previous exposure to ABT-450 or ABT-267.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assess the percentage of all dosed subjects in each treatment arm with sustained virologic response 24 weeks post-dosing (hepatitis C ribonicleic acid less than lower limit of quantitation at 24 weeks after the last dose of study grug). Post Treatment Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Assay the percentage of all dosed subjects in each treatment arm with a sustained virologic response 12 weeks post-dosing (hepatitis C ribonucleic acid less than lower limit of quantitaion 12 weeks after the last dose of study drug). Post Treatment Week 12 | — |
Outcome results
None listed