Chronic Hepatitis C Infection MedDRA version: 19.1 Level: PT Classification code 10008912 Term: Chronic hepatitis C System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: ABT-450/Ritonavir/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
O
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. HCV GT1 or GT4 infection defined as: Positive for anti-HCV Ab, HCV RNA >1,000 IU/mL and laboratory result indicating HCV GT1 infection at Screening. 3. Evidence of cirrhosis by prior liver biopsy, FibroScan or by radiograph (ie CT or MRI). 4. Child-Pugh Score 7-9 inclusive at time of 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 55 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: 1. Women who are pregnant or breastfeeding. 2. Positive test result for Hepatitis B surface antigen (HbsAg) or anti-HIV antibodies (HIV Ab) with positive Western blot. 3. Prior or current use of any other investigational or commercially available anti-HCV agents other than interferon/RBV and/or pegIFN/RBV (including but not limited to telaprevir, boceprevir, sofosbuvir and simeprevir) 4. Confirmed presence of hepatocellular carcinoma indicated on imaging techniques such as computed tomography (CT) scan or magnetic resonance imaging (MRI) within 3 months prior to Screening or on an ultrasound performed at Screening (a positive ultrasound result will be confirmed with CT scan or MRI). 5. Any current or past evidence of Child-Pugh C classification
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: The secondary objectives of this study are to assess the percentage of subjects with virologic failure during treatment and the percentage of subjects with virologic relapse;Primary end point(s): The primary endpoint is the percentage of subjects with SVR12. ;Timepoint(s) of evaluation of this end point: 12 weeks after last dose of study drugs;Main Objective: The primary objectives of this study are to assess the safety and the percentage of subjects achieving a 12-week sustained virologic response, SVR12 [Hepatitis C Virus (HCV) ribonucleic acid (RNA) < lower limit of quantification (LLOQ) 12 weeks following treatment] of coformulated ABT-450, ritonavir and ABT-267 (ABT-450/r/ABT-267) and ABT-333 with ribavirin (RBV) for 12 or 24 weeks in HCV genotype 1 (GT1)-infected adults with decompensated cirrhosis | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. The percentage of subjects with virologic failure during treatment with confirmed quantifiable HCV RNA 2. The percentage of subjects with relapse post-treatment, with confirmed quantifiable HCV RNA 3. Percentage of participants with improvement in laboratory parameters associated with hepatic function. 4. The percentage of GT4 subjects with SVR12.;Timepoint(s) of evaluation of this end point: 1. 12 or 24 weeks depending on treatment arm; 2. 48 weeks after last dose of study drugs | — |
Countries
Canada, European Union, Germany, United States
Contacts
Public ContactEU Clinical Trials Helpdesk
AbbVie Ltd.
Outcome results
None listed