An Open-Label Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir with or without Dasabuvir in Adults with Genotype 1a or Genotype 4 Chronic Hepatitis C Virus (HCV) Infection, with Severe Kidney Impairment or End-Stage Kidney Disease (RUBY-II)

Phase 1

• Conditions: Chronic Hepatitis C infection; MedDRA version: 18.0Level: PTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2015-002012-33-ES
• 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: 2015-07-31
• Study Completion: 2016-12-05
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

1. Chronic HCV infection.
2. Screening laboratory result indicating either HCV genotype 1a or genotype 4 infection.
3. Subject has never received antiviral treatment for hepatitis C infection.
4. Estimated Glomerular Filtration Rate (eGFR) < 30 mL/min/1.73 m2 as estimated by the MDRD method
5. No evidence of liver cirrhosis.
6. Females must be post-menopausal for more than 2 years or surgically sterile or practicing acceptable forms of birth control
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 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4

Exclusion Criteria

1. Women who are pregnant or breastfeeding.
2. Positive test result for Hepatitis B surface antigen (HbsAg) or anti-Human immunodeficiency virus antibody (HIV Ab)
3. Clinically significant abnormalities or co-morbidities, other than HCV infection that make the subject an unsuitable candidate for this study or to receive ombitasvir/paritaprevir/ritonavir or dasabuvir.
4. Any prior antiviral therapy for HCV, including investigational or commercially approved agents.
5. Any current or past clinical evidence of cirrhosis.

Study & Design

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