NCT03202498

Safety and Tolerability of Yaq-001 in Patients With Cirrhosis

Terminated NA Last updated 25 August 2020

What this trial tests

NA trial testing 4g Yaq-001 in Liver Cirrhosis in 31 participants. Terminated before completion.

Timeline

28 February 2019

Primary endpoint
26 March 2020

26 March 2020

Quick facts

Lead sponsor	Yaqrit Ltd
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	quadruple
Primary purpose	device feasibility
Enrollment	31
Start date	28 February 2019
Primary completion	26 March 2020
Estimated completion	26 March 2020
Sites	9 locations across France, Italy, United Kingdom, Switzerland, Portugal, Spain

Drugs / interventions tested

• 4g Yaq-001
• 4g Placebo
• 8g Yaq-001
• 8g Placebo

Conditions studied

• Liver Cirrhosis — all drugs for Liver Cirrhosis →

Sponsor

Yaqrit Ltd

Who can join

18 and older, any sex, with Liver Cirrhosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Gut liver brain axis in diseases: the implications for therapeutic interventions.
   Yan M, Man S, Sun B, Ma L, et al · · 2023 · cited 165× · PMID 38057297 · DOI 10.1038/s41392-023-01673-4
2. Molecular and Cellular Mediators of the Gut-Liver Axis in the Progression of Liver Diseases.
   Bruneau A, Hundertmark J, Guillot A, Tacke F. · · 2021 · cited 59× · PMID 34650994 · DOI 10.3389/fmed.2021.725390
3. Diet-induced gut dysbiosis and inflammation: Key drivers of obesity-driven NASH.
   Kang GG, Trevaskis NL, Murphy AJ, Febbraio MA. · · 2023 · cited 57× · PMID 36691622 · DOI 10.1016/j.isci.2022.105905
4. Liver cirrhosis and immune dysfunction.
   Hasa E, Hartmann P, Schnabl B. · · 2022 · cited 44× · PMID 35792761 · DOI 10.1093/intimm/dxac030
5. The shaping of gut immunity in cirrhosis.
   Muñoz L, Caparrós E, Albillos A, Francés R. · · 2023 · cited 16× · PMID 37122743 · DOI 10.3389/fimmu.2023.1139554
6. Exploring the Relationship between Liver Disease, Bacterial Translocation, and Dysbiosis: Unveiling the Gut-Liver Axis.
   Juanola O, Francés R, Caparrós E. · · 2024 · cited 12× · PMID 38312368 · DOI 10.1159/000535962
7. Clinical, experimental and pathophysiological effects of Yaq-001: a non-absorbable, gut-restricted adsorbent in models and patients with cirrhosis.
   Liu J, MacNaughtan J, Kerbert AJC, Portlock T, et al · · 2024 · cited 11× · PMID 38621924 · DOI 10.1136/gutjnl-2023-330699
8. Organoid-Guided Precision Medicine: From Bench to Bedside.
   Tao B, Li X, Hao M, Tian T, et al · · 2025 · cited 10× · PMID 40321594 · DOI 10.1002/mco2.70195