NCT03963921

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)

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 2019

Geographic Reach
4 countries

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 9, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 23, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 28, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 28, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2020

Completed
Last Updated

October 14, 2020

Status Verified

October 1, 2020

Enrollment Period

1.1 years

First QC Date

May 23, 2019

Last Update Submit

October 13, 2020

Conditions

NASH - Nonalcoholic Steatohepatitis

Keywords

NASH

Outcome Measures

Primary Outcomes (1)

  • Incidence of Adverse Event

    Safety and Tolerability

    up to Day 28

Study Arms (2)

F4 patient population

EXPERIMENTAL

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

Drug: HepaStem

F3 patient population

EXPERIMENTAL

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

Drug: HepaStem

Interventions

HepaStemDRUG

Heterologous human adult liver-derived progenitor cells

F3 patient populationF4 patient population

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

CUB Erasme

Brussels, 1070, Belgium

Location

Cliniques Universitaires St Luc

Brussels, 1200, Belgium

Location

University Hospital Antwerp (UZA)

Edegem, 2650, Belgium

Location

UZ Gent

Ghent, 9000, Belgium

Location

University Multiprofile Hospital for Active Treatment "Tsaritsa Yoana - ISUL"

Sofia, 1527, Bulgaria

Location

Multiprofile hospital for active treatment (MHAT) Sofia Military Medical Academy

Sofia, 1606, Bulgaria

Location

Trakia Park Hospital

Stara Zagora, 6004, Bulgaria

Location

CHU Bordeaux

Bordeaux, 33604, France

Location

Paul Brousse Hospital

Villejuif, 94804, France

Location

Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain

Location

Hospital General Universitario Gregorio Marañon

Madrid, 28007, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Study Officials

  • Etienne SOKAL, MD, PhD

    CSMO

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2019

First Posted

May 28, 2019

Study Start

April 9, 2019

Primary Completion

May 28, 2020

Study Completion

August 31, 2020

Last Updated

October 14, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)ES(4)BU(3)BE(4)