CARBALIVE-SAFETY (version 6.0)
Research type
Research Study
Full title
SAFETY AND TOLERABILITY OF YAQ-001 IN PATIENTS WITH CIRRHOSIS
IRAS ID
201500
Contact name
Gautam Mehta
Contact email
Sponsor organisation
Yaqrit Ltd
ISRCTN Number
ISRCTN16926948
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
In patients with cirrhosis (scarring of the liver), bacterial fragments leak from the gut into the blood and cause harm. This study looks into a new way to lower the leakage of bacterial fragments into the blood.
Yaq-001 is a new type of carbon that in previous laboratory studies has been shown to have the ability to bind these bacterial fragments and so confine them to the gut. The purpose of this clinical trial is to test the product Yaq-001 for the first time in patients with cirrhosis.
This trial will assess if the treatment with Yaq-001 is safe, is well tolerated, and if it helps improve the overall health status of the cirrhotic patients.
Candidate patients must be at least 18 years old and have a clinical diagnosis of cirrhosis for any cause. Only postmenopausal women or with surgical sterilisation are eligible. Additional inclusion and exclusion criteria of medical nature will be determined with the investigator at the screening visit, by means of standard care routines plus an additional test to assess the bowel transit time.
Eligible patients will be randomly grouped to receive standard care treatment plus Yaq-001, or standard treatment plus placebo (non-active treatment). The use of placebo is necessary to better understand how safe and tolerable Yaq-001 really is.
The treatment lasts for 12 weeks. During treatment, the patient will be visited by a study doctor 5 times. At all the visits the patients will undergo a routine physical examination, electrocardiogram, collection of blood and urine samples. On three occasions the patients will be asked to provide additional samples of blood, urine and stool for analysis outside the hospital.
56 patients from 9 hospitals in UK, France, Italy, Portugal, Spain and Switzerland will participate in this study.
REC name
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
17/SW/0144
Date of REC Opinion
27 Sep 2017
REC opinion
Further Information Favourable Opinion