M15-461 (RUBY-II) - GT 1a or 4 Chronic HCV with Renal Impairment
Research type
Research Study
Full title
Clinical Study Protocol M15-461: 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 Renal Impairment or End-Stage Renal Disease (RUBY-II)
IRAS ID
183508
Contact name
Kaushik Agarwal
Contact email
Sponsor organisation
AbbVie
Eudract number
2015-002012-33
Duration of Study in the UK
1 years, 1 months, 31 days
Research summary
Hepatitis C virus (HCV) infection is among the most common of all chronic liver diseases. HCV predominantly affects liver cells and causes the liver to become inflamed and damaged. This can lead to cirrhosis (scarring of the liver) and liver cancer, and patients may then need a liver transplant.
The presence of Hepatitis C virus is common among those with end stage renal disease (when the kidneys permanently fail to work). Historically, these patients have not received treatment for their HCV infection as the medicines available include interferon and ribavirin, which when combined together are not well-tolerated by patients with renal disease due to the side effects that often occur.
Drug companies are developing drugs called ‘Direct Acting Antiviral Agents’ (DAAs) which work by targeting the different stages of the virus lifecycle. DAAs provide an alternative option to injectable therapies for Hepatitis C patients and are generally well tolerated.
This study will test the safety and effectiveness of ombitasvir, paritaprevir and ritonavir over a 12 week treatment course, in treatment-naïve (those who have received no previous treatment for their HCV) subjects without cirrhosis and with severe renal impairment (pre-dialysis) or end-stage renal disease (on dialysis), either with dasabuvir (3-DAA) for subjects with genotype 1a infection, or without Dasabuvir (2-DAA) for subjects with HCV genotype 4 infection.
Approximately 40 subjects will be included across approximately 15 sites worldwide. Subjects will attend regular study visits at clinics during the course of the study. Participation in this study will last approximately 36 weeks. Subjects will receive study medication for 12 weeks then follow up for 24 weeks. Safety and efficacy evaluations will occur throughout the study.REC name
London - Central Research Ethics Committee
REC reference
15/LO/1228
Date of REC Opinion
3 Sep 2015
REC opinion
Further Information Favourable Opinion