A Study to evaluate Glecaprevir/Pibrentasvir in adults with Chronic Hepatitis C Virus Genotype 1-6 infection, with APRI (a predictor of hepatic fibrosis) = 1, who have never received HCV treatment

Phase 1

• Conditions: Chronic Hepatitis C infection; MedDRA version: 20.0 Level: LLT Classification code 10019751 Term: Hepatitis C virus System Organ Class: 100000074171; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2016-004876-23-GB
• Lead Sponsor: AbbVie Deutschland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-06-21
• Study Completion: 2018-08-13
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 230

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 < LLOQ in subjects with isolated positive anti-HBc (i.e., negative HBsAg and Anti hepatitis B surface [HBs])
3. Positive anti- HCV antibody (Ab) AND Plasma HCV RNA viral load = 1000 IU/mL at Screening.
4. Any HCV GT allowed, including HCV GT1-, 2-, 3-, 4-, 5-, and/or 6-infection. Mixed GT and indeterminate GT may be acceptable.
5. APRI SCORE = 1, at time of Screening
6. Subject is treatment naïve, e.g., has never received any other investigational or commercially available anti-HCV agents (e.g.,interferon, peginterferon, ribavirin [RBV], telaprevir, boceprevir, simeprevir, asunaprevir, paritaprevir, grazoprevir, daclatasvir, ledipasvir, ombitasvir, elbasvir, dasabuvir, voxilaprevir or any other anti-HCV agent that is approved during the study).
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 207
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 23

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)

Study & Design

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