Safety and Tolerability of Yaq-001 in Patients With Cirrhosis

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.

Conditions

• Liver Cirrhosis

Interventions

DEVICE

4g Yaq-001

Study patients will be dosed daily with 4g of product Yaq-001 for a period of 12 weeks. The product will be provided as beads packed in individual sachets intended each for one oral administration. 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.

OTHER

4g Placebo

Study patients will be dosed daily with a quantity of placebo equivalent to 4g of product Yaq-001 for a period of 12 weeks. The product will be provided as beads packed in individual sachets intended each for one oral administration. 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.

DEVICE

8g Yaq-001

Study patients will be dosed daily with 8g of product Yaq-001 for a period of 12 weeks. The product will be provided as beads packed in individual sachets intended each for one oral administration. 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.

OTHER

8g Placebo

Study patients will be dosed daily with a quantity of placebo equivalent to 8g of product Yaq-001 for a period of 12 weeks. The product will be provided as beads packed in individual sachets intended each for one oral administration. 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.

Sponsors & Collaborators

• University College, London

  collaborator OTHER

• University of Brighton

  collaborator OTHER

• Institut d'Investigacions Biomèdiques August Pi i Sunyer

  collaborator OTHER

• Azienda Ospedaliera di Padova

  collaborator OTHER

• Hospital Universitari Vall d'Hebron Research Institute

  collaborator OTHER

• IRCCS Azienda Ospedaliero-Universitaria di Bologna

  collaborator OTHER

• University of Lisbon

  collaborator OTHER

• Servicio Madrileño de Salud, Madrid, Spain

  collaborator OTHER

• University of Bern

  collaborator OTHER

• Assistance Publique - Hôpitaux de Paris

  collaborator OTHER

• A2F Associates Limited

  collaborator OTHER

• Alpha Bioresearch S.L.

  collaborator OTHER

• Yaqrit Ltd

  lead INDUSTRY

Principal Investigators

• Rajiv Jalan · Head, Liver Failure Group ILDH, Division of Medicine UCL Medical School Royal Free Campus Rowland Hill Street London NW32PF

• Jane Macnaughtan · Consultant, Liver Failure Group, ILDH, Division of Medicine UCL Medical School Royal Free Campus Rowland Hill Street London NW32PF

Study Design

Allocation

RANDOMIZED

Purpose

DEVICE_FEASIBILITY

Masking

QUADRUPLE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-02-28

Primary Completion

2020-03-26

Completion

2020-03-26

Countries

• France
• Italy
• Portugal
• Spain
• Switzerland
• United Kingdom

Study Locations