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

Sponsor
Promethera Therapeutics (Industry)
Overall Status
Completed
CT.gov ID
NCT03963921
Collaborator
(none)
23
Enrollment
13
Locations
2
Arms
16.8
Actual Duration (Months)
1.8
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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)

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
23 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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)
Actual Study Start Date :
Apr 9, 2019
Actual Primary Completion Date :
May 28, 2020
Actual Study Completion Date :
Aug 31, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: F4 patient population

A total of 2 doses are planned to be administered as single or repeated infusions in an ascending manner:

Drug: HepaStem
Heterologous human adult liver-derived progenitor cells
Experimental: F3 patient population

A total of 2 doses are planned to be administered as single or repeated infusions in an ascending manner:

Drug: HepaStem
Heterologous human adult liver-derived progenitor cells

Outcome Measures

Primary Outcome Measures

  1. Incidence of Adverse Event [up to Day 28]

    Safety and Tolerability

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cliniques Universitaires St Luc Brussels Belgium 1200
2 CUB Erasme Brussel Belgium 1070
3 University Hospital Antwerp (UZA) Edegem Belgium 2650
4 UZ Gent Gent Belgium 9000
5 University Multiprofile Hospital for Active Treatment "Tsaritsa Yoana - ISUL" Sofia Bulgaria 1527
6 Multiprofile hospital for active treatment (MHAT) Sofia Military Medical Academy Sofia Bulgaria 1606
7 Trakia Park Hospital Stara Zagora Bulgaria 6004
8 CHU Bordeaux Bordeaux France 33604
9 Paul Brousse Hospital Villejuif France 94804
10 Vall d'Hebron Barcelona Spain 08035
11 Hospital de la Santa Creu i Sant Pau Barcelona Spain 08041
12 Hospital General Universitario Gregorio Marañon Madrid Spain 28007
13 Hospital Universitario Ramón y Cajal Madrid Spain 28034

Sponsors and Collaborators

  • Promethera Therapeutics

Investigators

  • Study Chair: Etienne SOKAL, MD, PhD, CSMO

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Promethera Therapeutics
ClinicalTrials.gov Identifier:
NCT03963921
Other Study ID Numbers:
  • HEP201
First Posted:
May 28, 2019
Last Update Posted:
Oct 14, 2020
Last Verified:
Oct 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Promethera Therapeutics
NASH
Additional relevant MeSH terms:
Fatty Liver
Non-alcoholic Fatty Liver Disease

Study Results

No Results Posted as of Oct 14, 2020