Safety and Tolerability of Yaq-001 in Patients With Cirrhosis

NATerminatedINTERVENTIONAL
Enrollment

31

Participants

Timeline

Start Date

February 28, 2019

Primary Completion Date

March 26, 2020

Study Completion Date

March 26, 2020

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.

Trial Locations (9)

3010

Inselspital Universitaet Bern, Department for Visceral Surgery and Medicine,, Bern

28034

Hospital Ramon y Cajal, Department of Gastroenterology and Hepatology, Madrid

35128

Azienda Ospedaliera di Padova, Hepatic Emergencies Unit, Padua

40138

Policlinico S.Orsola Malpighi, Department of Medical and Surgical Sciences, Bologna

82110

Hospital Beaujon, Hepatology and Liver Intensive Care,, Clichy

1649-035

University Hospital of Santa Maria, Lisbon

08035

Hospital Vall d'Hebron, Liver Unit, Barcelona

08036

Hospital Clinic of Barcelona , Liver Unit,, Barcelona

NW3 2PF

Royal Free Hospital, Institute of Liver and Digestive Disease, London

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

University College, London

OTHER

collaborator

University of Brighton

OTHER

collaborator

Institut d'Investigacions Biomèdiques August Pi i Sunyer

OTHER

collaborator

Azienda Ospedaliera di Padova

OTHER

collaborator

Hospital Universitari Vall d'Hebron Research Institute

OTHER

collaborator

IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

collaborator

University of Lisbon

OTHER

collaborator

Servicio Madrileño de Salud, Madrid, Spain

OTHER

collaborator

University of Bern

OTHER

collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

collaborator

A2F Associates Limited

OTHER

collaborator

Alpha Bioresearch S.L.

OTHER

lead

Yaqrit Ltd

INDUSTRY