Safety and Tolerability of HepaStem in Patients With Cirrhotic and Pre-cirrhotic NASH Patients

NASH - Nonalcoholic Steatohepatitis Clinical Trial

— PANASH  

Official title:

Multicenter, Open-label, Safety and Tolerability Study of Ascending Doses of HepaStem in Patients With Cirrhotic and Pre-cirrhotic Non-alcoholic Steato-hepatitis (NASH)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03963921
• Other study ID #: HEP201
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: April 9, 2019
• Est. completion date: August 31, 2020

Study information

• Verified date: October 2020
• Source: Promethera Biosciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Multicenter, open-label, safety and tolerability study of ascending doses of HepaStem in patients with cirrhotic and pre-cirrhotic non-alcoholic steato-hepatitis (NASH) to determine the safety and tolerability of ascending single and repeated doses of HepaStem administered to patients with cirrhotic and pre-cirrhotic non-alcoholic steato-hepatitis (NASH)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: August 31, 2020
• Est. primary completion date: May 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Main Inclusion Criteria:

• Able and willing to provide written informed consent and comply with the requirements of this study protocol

• Age 18 to 70-years old, inclusive

• Proven diagnosis of NASH based on histological evidence from biopsy performed within 6 months for F3 patients and within 2 years for F4 patients prior to Screening If no biopsy is available within these time windows, a biopsy should be performed at Screening NB: For F4 patients for whom the biopsy cannot confirm the diagnosis of NASH, any other causes of underlying liver diseases should be excluded

Main Exclusion Criteria:

• Alcoholic liver disease or alcohol consumption exceeding the daily intake of 140g/w (two doses) for women and of 210g/w (three doses) for men

• Other causes of liver disease including, but not limited to, alcoholic liver disease, active hepatitis B (HbsAg+), hepatitis C (PCR positive), autoimmune disorders, drug-induced hepatotoxicity, Wilson disease, hemochromatosis, and alpha-1-antitryspin deficiency based on medical history and/ or clinical and biological assessment

• Recent recurrent or ongoing thrombotic or bleeding events within 3 months prior the screening

• Patients considered at persistent risk of thrombosis or bleeding at the time of screening

• Patients with high risk of Gastro intestinal bleeding at time of the screening.

• Cerebrovascular, myocardial, or limb arterial thrombotic event within 12 months prior to the screening and/or not considered stabilized by the investigator

• Bariatric surgery within 1 year prior to the screening

• Coagulation disturbances defined as (Drolz et al. 2016, Nadim et al. 2016, Stravitz et al. 2018, Green et al. 2018): fibrinogen at < 80 mg/dL and/or platelets at < 40 x 10³/mm3

• Severe hepatic encephalopathy (defined by West Haven grade > 2)

• Acute Decompensation of cirrhosis with Chronic Liver Failure Consortium Acute Decompensation (CLIF-C AD) score > 60

• Acute on Chronic liver failure (ACLF) grade 1, 2 ,3

• MELD score > 20

• Child Pugh score = C

Related Conditions & MeSH terms

• Fatty Liver
• NASH - Nonalcoholic Steatohepatitis
• Non-alcoholic Fatty Liver Disease

Intervention

Drug:
• HepaStem
Heterologous human adult liver-derived progenitor cells

Locations

Country	Name	City	State
Belgium	CUB Erasme	Brussel
Belgium	Cliniques Universitaires St Luc	Brussels
Belgium	University Hospital Antwerp (UZA)	Edegem
Belgium	UZ Gent	Gent
Bulgaria	Multiprofile hospital for active treatment (MHAT) Sofia Military Medical Academy	Sofia
Bulgaria	University Multiprofile Hospital for Active Treatment "Tsaritsa Yoana - ISUL"	Sofia
Bulgaria	Trakia Park Hospital	Stara Zagora
France	CHU Bordeaux	Bordeaux
France	Paul Brousse Hospital	Villejuif
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	Vall d'Hebron	Barcelona
Spain	Hospital General Universitario Gregorio Marañon	Madrid
Spain	Hospital Universitario Ramón y Cajal	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Promethera Biosciences

Countries where clinical trial is conducted

Belgium,  Bulgaria,  France,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Adverse Event	Safety and Tolerability	up to Day 28