Liver Cirrhosis Clinical Trial
Official title:
Safety and Tolerability of Yaq-001 in Patients With Cirrhosis ("CARBALIVE-SAFETY")
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.
First-in-human clinical investigation with Yaq-001. This is a multicentre, randomized, double
blinded, placebo controlled trial to intended to evaluate safety and tolerability of oral
administration of Yaq-001 therapy in two dosing cohorts.
56 cirrhotic patients with diuretic-responsive ascites will be enrolled. Patients will be
randomized to two dosing cohorts.
Cohort 1 (1:1 randomization)
- Standard medical treatment + Yaq-001 (4 g/ day) - n= 14.
- Standard medical treatment + placebo-control (placebo for 4 g of Yaq-001/ day) - n= 14.
Cohort 2 (1:1 randomization)
- Standard medical treatment + Yaq-001 (8 g/ day) - n= 14.
- Standard medical treatment + placebo-control (placebo for 8 g of Yaq-001/ day) - n= 14.
Study patients will be dosed daily with Yaq-001 (or an equivalent quantity of placebo) for 12
weeks. Assessments of DSMB will take place after 4 and 12 weeks. Investigational centres
specialized in the management of patients with liver cirrhosis will participate in the study.
For each patient, the study duration will be up to 17 weeks, including the screening (up to 4
weeks), treatment (12 weeks) and 7-day follow up period.
The total study duration is estimated to be approximately 6 months from screening of first
patient until study completion of the last patient.
This project has received funding from the European Union's Horizon 2020 research and
innovation programme under grant agreement No 634579.
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