Chronic Hepatitis C Virus (HCV) Infection MedDRA version: 18.0 Level: PT Classification code 10008912 Term: Chronic hepatitis C System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: ABT-450/r/Ombitasvir
Product Code: ABT-450/r/ABT-267
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: ABT-450
CAS Number: 1456607-71-8
Current Sponsor code: ABT-450
Other des
Sponsors
AbbVie Deutschland GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female at least 18 years of age at time of screening. 2. Screening laboratory result indicating HCV GT1a infection. 3. Chronic HCV infection. 4. Subjects must be non-cirrhotic. 5. Subjects must be able to understand and adhere to the study visit schedule and all protocol requirements as well as voluntarily sign and date an IRB/EC approved informed consent. 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 45 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: 1. Women who are pregnant or breastfeeding. 2. Positive test result for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab) positive immunoassay. 3. Clinically significant abnormalities or co-morbidiites, other than HCV infection, that make the subject unsuitable for this study or treatment. 4. Current enrollment in another interventional clinical study. Previous use of any HCV treatments including pegIFN, ribavirin, or any direct acting antiviral agent, either investigational or approved, for HCV including protease inhibitors, nucleoside or non-nucleoside polymerase inhibitors, or NS5A inhibitors. 5. History of solid organ transplant. 6. Screening laboratory analysis that shows abnormal results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: HCV RNA early viral load decline in the plasma following combination of ombitasvir/ABT-450/r and dasabuvir administered with low dose, full dose, or no RBV in treatment-naive HCV genotype GT 1a-infected adults;Secondary Objective: None;Primary end point(s): The slope of the second phase decline in plasma HCV RNA levels during treatment.;Timepoint(s) of evaluation of this end point: From Week 0 to Week 2 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): None | — |
Countries
France, United States
Contacts
Public ContactEU Clinical Trials Helpdesk
AbbVie Ltd.
Outcome results
None listed