Chronic Hepatitis C Infection MedDRA version: 14.1 Level: PT Classification code 10008909 Term: Chronic hepatitis System Organ Class: 10019805 - Hepatobiliary disorders
Conditions
Interventions
Product Name: ABT-450
Pharmaceutical Form: Tablet
Current Sponsor code: ABT-450
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Product Name: ABT-267
Pharmaceu
Sponsors
Abbott GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Male or female between the age of 18 and 70 years, inclusive, at time of enrollment. 2.Subjects must meet one of the following categories: ?Never received antiviral treatment for hepatitis C infection; ?Documented null-response (received at least 10 weeks of pegIFN/RBV for the treatment of HCV and failure to achieve a 2 log10 IU/ml reduction in HCV RNA at week 12 (Week 10-16). 3.Body mass index (BMI) is ? 18 to 10,000 IU/mL at Screening. 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 180 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: 1.History of severe, life-threatening or other significant sensitivity to any drug. 2.Females who are pregnant or breastfeeding. 3.Recent history of drug or alcohol abuse that could preclude adherence to the protocol. 4.Positive test result for hepatitis B surface antigen or anti-HIV antibodies. 5.Any current or past clinical evidence of cirrhosis such as ascites or esophageal varices, or prior biopsy showing cirrhosis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to assess the safety and efficacy (the percentage of subjects with HCV RNA < LLOQ 12 weeks after the last dose of study drug [SVR12]) comparing Groups 1 and 2 and Groups 4 and 5.;Secondary Objective: - To assess the percentage of subjects with SVR12 (HCV RNA < LLOQ 12 weeks after the last dose of study drug), comparing Groups 2 and 3, - To assess the percentage of subjects with SVR24 (HCV RNA < LLOQ 24 weeks after the last dose of study drug), comparing Groups 1 and 2, Groups 4 and 5, and Groups 2 and 3, - To assess the percentage of subjects with end of treatment response (HCV RNA < LLOQ at the end of treatment), comparing Groups 1 and 2, Groups 4 and 5, and Groups 2 and 3;Primary end point(s): The primary objective of this study is to assess the safety and efficacy (the percentage of subjects with HCV RNA < LLOQ 12 weeks after the last dose of study drug [SVR12]) comparing Groups 1 and 2 and Groups 4 and 5.;Timepoint(s) of evaluation of this end point: 12 weeks after last dose of study drug | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - To assess the percentage of subjects with SVR12 (HCV RNA < LLOQ 12 weeks after the last dose of study drug), comparing Groups 2 and 3, - To assess the percentage of subjects with SVR24 (HCV RNA < LLOQ 24 weeks after the last dose of study drug), comparing Groups 1 and 2, Groups 4 and 5, and Groups 2 and 3, - To assess the percentage of subjects with end of treatment response (HCV RNA < LLOQ at the end of treatment), comparing Groups 1 and 2, Groups 4 and 5, and Groups 2 and 3;Timepoint(s) of evaluation of this end point: 24 weeks after last dose of study drug, 4 weeks after first dose of study drug, End of treatment | — |
Countries
France, Hungary, Italy, Poland, Puerto Rico, Romania, Spain, Turkey, United States
Contacts
Public ContactEU Clinical Trials Helpdesk
Abbott Laboratories
Outcome results
None listed