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

• Status: Completed
• Trial end date: 2020-08-31
• Target enrollment: 0
• Participant gender: All

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)

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Promethera Biosciences

Criteria

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