Hepatitis C Virus
Conditions
Interventions
Trade Name: Maviret
Product Name: Glecaprevir/Pibrentasvir
Pharmaceutical Form: Tablet
INN or Proposed INN: GLECAPREVIR
Other descriptive name: GLE
Concentration unit: mg milligram(s)
Concentration ty
Sponsors
AbbVie
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Adult or adolescent, age 12 years and older weighing at least 45 kg. - Subject must have evidence of acute HCV infection prior to enrollment. Evidence of acute HCV infection is defined as physician diagnosis of acute HCV infection and at least 1 of the following: - Negative anti-HCV antibody, HCV RNA and/or HCV core antigen followed by a positive HCV RNA or HCV core antigen all within an 8-month period prior to Screening OR Negative anti-HCV antibody, HCV RNA and/or HCV core antigen followed by a positive HCV RNA or HCV core antigen all within an 11-month period prior to Screening; AND risk behavior for HCV infection within 6 months prior to positive HCV RNA or HCV core antigen OR Clinical signs and symptoms compatible with acute hepatitis (ALT > 5 × ULN and/or jaundice) in the absence of a history of chronic liver disease or other cause of acute hepatitis and positive HCV RNA or HCV core antigen all within an 8-month period prior to Screening; AND risk behavior for HCV infection within 6 months prior to positive HCV RNA or HCV core antigen OR Negative anti-HCV antibody with a positive HCV RNA or HCV core antigen within a 5-month period prior to Screening. - Subject must be HCV treatment-naïve, defined as no prior treatment including interferon for this HCV infection. - Subject must be documented as either having no cirrhosis or as having compensated cirrhosis. - Absence of hepatocellular carcinoma (HCC) for subjects with cirrhosis as indicated by a negative ultrasound, computed tomography (CT) scan or magnetic resonance imaging (MRI) within 3 months prior to Screening or a negative ultrasound at Screening. Subject who has a positive ultrasound result suspicious of HCC followed by a subsequent negative CT scan or MRI or biopsy result will be eligible for the study. - No history of liver decompensation Are the trial subjects under 18? yes Number of subjects for this age range: 15 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 253 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: - Evidence of chronic HCV infection for this HCV infection. - Subject has a history of severe life-threatening or other significant sensitivity to any excipients of the study drug. - Subject has cause of liver disease other than HCV infection - Subject has uncontrolled drug use that may impair protocol compliance in the opinion of the investigator. - Female who is pregnant or breastfeeding; or is considering becoming pregnant or donating eggs during the study or for approximately 30 days after the last dose of study drug. - Subject must require chronic use of systemic immunosuppressants during the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to demonstrate the efficacy of 8-week treatment with GLE/PIB in adults and adolescents with confirmed acute HCV infection by comparing the SVR12 rate from this study to the historical SVR12rate in subjects with chronic HCV infection who were treated with GLE/PIB. The primary efficacy objective will be assessed based on the ITT population which is defined as all enrolled subjects who received at least 1 dose of study drug.;Secondary Objective: The key secondary objective of this study is the same as the primary objective of this study except that the key secondary objective will be assessed in the modified ITT – virologic failure (mITT-VF) population. The mITT-VF population is defined as all enrolled subjects who received at least one dose of study drug, excluding those who did not achieve SVR12for reasons other than virologic failure (i.e., those with HCV reinfection, those who did not achieve SVR12due to early premature discontinuation of study drug, and those who were missing HCV RNA data in the SVR12window after backward imputation). The other secondary objectives of this study are to determine the on-treatment virologic failure, post-treatment relapse, and post-treatment reinfection rates in the ITT population.;Primary end point(s): The primary endpoint is the achievement of SVR12(defined as HCV RNA < the lower limit of quantification [LLOQ] 12 weeks after the last actual dose of study drug) for each subject in the ITT population.;Timepoint(s) of evaluation of this end point: Treatment Day 1 to end of treatment; end of treatment to post treatment week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The key secondary endpoint is achievement of SVR12for each subject in the mITT-VF population.;Timepoint(s) of evaluation of this end point: Treatment Day 1 to end of treatment; end of treatment to post treatment week 12 | — |
Countries
Australia, Austria, Canada, France, Germany, Spain, United States
Contacts
Public ContactGlobal Clinical Trials Helpdesk
AbbVie Ltd
Outcome results
None listed