SMART-C
Research type
Research Study
Full title
A phase IIIb, open-label, multicentre, international randomised controlled trial of simplified treatment monitoring for 8 weeks glecaprevir (300mg)/pibrentasvir (120mg) in chronic HCV treatment naïve patients without cirrhosis
IRAS ID
226023
Contact name
Kaushik Agarwal
Contact email
Sponsor organisation
University of New South Wales Sydney
Eudract number
2017-000694-37
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
The combination of glecaprevir (300mg)/pibrentasvir (120mg), a protease inhibitor and NS5A inhibitor, developed to treat patients infected with the Hepatitis C virus (HCV), has been tested in large volume clinical trials. Participants infected with HCV, without liver cirrhosis (when normal liver tissue is damaged and replaced by scar tissue), received 8 weeks of the combination drug. The treatment was shown to be safe and effective, curing almost 99% of people infected with HCV without cirrhosis regardless of their HCV strain (genotype). There was no need for ribavirin, which is an antiviral drug with serious side effects that is given in combination with other drugs used to treat HCV. Glecaprevir (300mg)/pibrentasvir (120mg) had no specific toxicity or side effects of treatment.
Due to this factor, and because no ribavirin is required, there is no need for monitoring of full blood count or liver function. The combination can be safely administered without regular monitoring of blood levels; as is the standard of care treatment for drugs used to treat HCV currently.
The aim of this study is to determine if on-treatment monitoring can be simplified for chronic HCV patients without cirrhosis receiving glecaprevir (300mg)/pibrentasvir (120mg) for 8 weeks.
One post treatment visit will be conducted 12 weeks after the final dose of study medication to evaluate the proportion of patients with undetectable HCV RNA at this timepoint (SVR12).REC name
London - South East Research Ethics Committee
REC reference
17/LO/1478
Date of REC Opinion
23 Nov 2017
REC opinion
Further Information Favourable Opinion