Chronic Hepatitis C infection MedDRA version: 20.0 Level: LLT Classification code 10019751 Term: Hepatitis C virus System Organ Class: 100000074171
Conditions
Sponsors
AbbVie Deutschland
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult male or female, at least 18 years old at the time of screening. 2. Laboratory values meeting the following criteria within the Screening period prior to the first dose of study drug: • Platelets = 150.000 cells/mm3 • Alanine aminotransferase (ALT) = 10 × upper limit of normal (ULN) • Aspartate aminotransferase (AST) = 10 × ULN • Direct bilirubin = ULN • Albumin = lower limit of normal (LLN) • Calculated creatinine clearance (using Cockcroft-Gault method) = 30 mL/min • A negative hepatitis B surface antigen (HBsAg), and negative anti-hepatitis B core(HBc) or; hepatitis B virus (HBV) DNA =65 years) yes F.1.3.1 Number of subjects for this age range 23
Exclusion criteria
Exclusion criteria: 1. Cirrhosis or past evidence of cirrhosis, described as: • previous histologic diagnosis of cirrhosis on liver biopsy, e.g., METAVIR, Batts-Ludwig, Knodell, IASL, Scheuer, or Laennec fibrosis score of > 3, Ishak score of > 4 in any liver biopsy conducted prior to screening, OR • Any previous transient elastography score of = 12.5 kPa, OR • Any current or historical clinical evidence of cirrhosis or decompensated cirrhosis, including any current or past evidence of Child-Pugh B or C classification, hepatic encephalopathy or variceal bleeding; radiographic evidence of ascites; or use of lactulose and/or rifaximin for hepatic encephalopathy prophylaxis or treatment. 2. History of hepatocellular carcinoma (HCC)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The primary efficacy endpoint is the percentage of subjects who achieve SVR12 (HCV RNA < LLOQ 12 weeks after the last actual dose of study drug) across genotypes in adults with HCV GT1 - GT6 based on mITT population.;Timepoint(s) of evaluation of this end point: 12 weeks after the last dose of study drug;Main Objective: To demonstrate the efficacy (by achieving high sustained virologic response 12 weeks post dosing [ SVR12] rate) and safety of 8 weeks of treatment with the GLE/PIB combination regimen in treatment naïve adults with HCV GT 1 - GT6 infection with APRI = 1. The primary efficacy objective will be assessed based on modified intention-to-treat (mITT) population across genotypes HCV GT1 - GT6.; Secondary Objective: The secondary objectives of this study are: • To demonstrate the efficacy (by achieving high SVR12 rate) of 8 weeks of treatment with the GLE/PIB combination regimen in treatment naïve adults with HCV GT1 - GT6 infection with APRI = 1 based on ITT population. • Assess the percentage of subjects with HCV on-treatment virologic failures across GTs in adults with HCV GT1 - GT6 infection with APRI = 1 based on ITT population. • Assess the percentage of subjects with HCV virologic relapse across GTs in adults with HCV GT1 - GT6 infection with APRI = 1 based on ITT population. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints are: • Percentage of subjects who achieve SVR12 (HCV RNA < LLOQ 12 weeks after the last actual dose of study drug) across GTs in adults with HCV GT1 - GT6 based on ITT population • Percentage of subjects with on-treatment virologic failure based on ITT population • Percentage of subjects with post-treatment relapse based on ITT population ;Timepoint(s) of evaluation of this end point: Treatment Day 1 to end of treatment and end of treatment to 12 weeks after the last dose of study drug. | — |
Countries
Bulgaria, Canada, Germany, Poland, Puerto Rico, Russian Federation, Spain, United Kingdom, United States
Contacts
Public ContactEU Clinical Trials Helpdesk
AbbVie Ltd
Outcome results
None listed