A Single Arm, Open-label Study to Evaluate the Efficacy and Safety of Glecaprevir (GLE)/Pibrentasvir (PIB) in Treatment Naïve Adults with Chronic Hepatitis C Virus (HCV) Genotype 1 - 6 Infection and Compensated Cirrhosis

Phase 1

• Conditions: HCV; MedDRA version: 20.0Level: LLTClassification code 10019752Term: Hepatitis C virus (HCV)System Organ Class: 100000004848; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2016-004967-38-PT
• Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-06-09
• Last Update Posted: 27 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 330

Inclusion Criteria

1. Male or female, at least 18 years of age at time of Screening;
2. Screening laboratory result indicating HCV GT 1 - 6 infection;
3. Positive plasma HCV antibody and HCV RNA viral load = 1000 IU/mL at Screening;
4. Treatment-naïve to any approved or investigational anti-HCV medication;
5. Subject must be documented as cirrhotic, with a Child-Pugh score of =6.
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 265
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 65

Exclusion Criteria

1. Female subject who is pregnant, breastfeeding or is considering becoming pregnant during the study, or for approximately 30 days after the last dose of study drug;
2. Any current or historical clinical evidence of decompensated cirrhosis, including any current or past evidence of Child-Pugh B or C classification, hepatic encephalopathy or variceal bleeding, radiographic evidence of small ascites, or empiric use of lactulose/rifaximin. The use of beta blockers is not exclusionary;
3. Current HBV or HIV infection on screening tests, defined as:
• A positive HBsAg, or;
• HBV DNA > LLOQ in subjects with isolated positive anti-HBc (i.e., negative HBsAg and Anti-HBs), or;
• A positive anti-human immunodeficiency virus antibody (HIV Ab).
4. HCV genotype performed by the central laboratory during screening indicating co-infection with more than one HCV genotype;
5. Screening laboratory analyses showing any of the following abnormal laboratory results:
• Alanine aminotransferase ALT > 10 × ULN
• Aspartate aminotransferase AST > 10 × ULN
• Total Bilirubin > 3.0 mg/dL
• Calculated creatinine clearance (CrCl, Cockcroft-Gault method) of < 50 mL/min
• Albumin < 2.8 mg/dL
• Hemoglobin < 10 g/dL
• Platelets < 50,000 cells/mm3
6. History of suspected or confirmed hepatocellular carcinoma.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified