A Multicenter Open-Label, Study to Evaluate the Efficacy and Safety of Glecaprevir/Pibrentasvir in Renally-Impaired Adults with Chronic Hepatitis C Virus Genotype 1 – 6 Infection (EXPEDITION-5)

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: EUCTR2016-004182-60-PL
• Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-30
• Last Update Posted: 7 January 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 101

Inclusion Criteria

1. Male or female at least 18 years of age at time of Screening.
2. Positive for anti-HCV antibody (Ab) at Screening and HCV RNA > 1,000 IU/mL at Screening.
3. Subject has an Estimated Glomerular Filtration Rate (eGFR) < 45mL/min/1.73 m2 as estimated by the MDRD method at screening according to the following formula:
eGFR (mL/min/1.73 m2) = 175 × (Serum Creatinine) – 1.154 × Age – 0.203 × (0.742 if female) × (1.212 if black), or is dialysis-dependent. Subjects requiring dialysis should have been receiving dialysis for at least 1 month prior to enrollment, and may be on hemodialysis or peritoneal dialysis.
4. Screening laboratory result indicating HCV GT1-, 2-, 3-, 4-, 5- and/or 6-infection.
5. Subject must be HCV treatment-naïve (i.e., patient has never received a single dose of any approved or investigational anti-HCV regimen) or treatment-experienced (i.e., subject has failed prior interferon [IFN] or pegylated interferon [pegIFN] with or without ribavirin [RBV], or sofosbuvir [SOF] plus RBV with or without pegIFN therapy). Prior HCV treatment with any other approved or investigational medications is not allowed. Previous HCV treatment must have been completed = 2 months prior to 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 71
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

Female who is pregnant, planning to become pregnant during the study, or breastfeeding during the study or for approximately 30 days after the last dose of study drug.
2. Positive test result at Screening for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab).
3. Clinical history of acute renal failure in the 3 months prior to screening.
4. Clinically significant abnormalities or co-morbidities, or recent (within 6 months prior to study drug administration) alcohol or drug abuse that make the subject an unsuitable candidate for this study in the opinion of the investigator.
5. Receipt of any other investigational or commercially available direct acting anti HCV agents other than sofosbuvir (e.g., telaprevir, boceprevir, simeprevir, paritaprevir, grazoprevir, daclatasvir, ledipasvir, ombitasvir, elbasvir, velpatasvir or dasabuvir).

Study & Design

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