| Trial ID: | L0483 |
| Source ID: | EUCTR2018-004449-18-FR
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| Associated Drug: |
HepaStem
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| Title: |
Multicenter, open-label, safety and tolerability study of ascending doses of HepaStem in patients with cirrhotic and pre-cirrhotic non-alcoholic steatohepatitis (NASH). - HEP201-PANASH
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| Acronym: |
--
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| Status: |
Not Recruiting
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| Study Results: |
No Results Available
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| Results: |
--
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| Conditions: |
NASH is characterized by steatosis, inflammation and cytological ballooning with varying amounts of fibrosis. Patients with NASH are at risk of cardiovascular morbidity and mortality. In chronic liver disease, changes in inflammatory components of the liv
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| Interventions: |
<br>Product Name: HepaStem<br>Product Code: HHALPC<br>Pharmaceutical Form: Suspension for injection<br>INN or Proposed INN: Heterologous Human Adult Liver-derived Progenitor Cells<br>Current Sponsor code: HepaStem<br>Other descriptive name: HHALPC<br>Conc
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| Outcome Measures: |
Main Objective: The primary objective of this trial is to determine the safety and tolerability of ascending single and repeated doses of HepaStem up to Day 28 administered to patients with cirrhotic and pre cirrhotic NASH.;Secondary Objective: 1. Secondary safety objective:<br>- To assess the appearance of anti-HLA Antigen antibodies and identification of donor HLA specificity following infusion of HepaStem<br>- To assess changes in levels of coagulation-related factors and coagulation efficiency up to 24 hours post-infusion<br>- To determine the safety and tolerability of HepaStem up to 6 months post-infusion<br><br>2. Preliminary efficacy objectives:<br>- To assess changes composite scores for disease stage: MELD, Child-Pugh scores and CLIF-C AD (for F4 decompensated)<br>- To assess changes in liver function tests <br>- To assess changes in metabolic biomarkers and clinical signs<br>- To assess changes in hepatic fibrosis by non-invasive methods<br><br>3. Exploratory objectives:<br>- To assess the effect of HepaStem on cellular immune response<br>- To assess changes in inflammatory, apoptosis, and NASH biomarkers<br>-To assess changes in non-invasive markers of portal hypertension<br>- To assess the evolution to acute decompensation of cirrhosis;Primary end point(s): Primary endpoint: dose-finding and safety<br><br>- AEs reported up to Day 28 assessed for seriousness, severity, relationship to the investigational medicinal product (IMP) and/or IMP administration procedure. This includes but is not limited to clinically changes in clinical examinations, vital signs, laboratory tests and imaging.;Timepoint(s) of evaluation of this end point: Primary endpoint: dose-finding and safety up to Day 28.Timepoint(s) of evaluation of this end point: - Secondary safety endpoints: up to Month 6<br>- Preliminary efficacy endpoints: up to Month 6<br>- Exploratory endpoints:<br>- Quantitative assessment of inflammatory, apoptosis, and NASH biomarkers from baseline to up to 6 months after last infusion<br>- AES up to day 28 assessed for seriousness, severity, relationship to the IMP and/or IMP administration procedure. This includes inflammation scores evaluated on Liver histology prior and 6 months post infusion<br>- Sub-study endpoints:<br>- Quantitative assessment of HPVG prior and 6 months post infusion;Secondary end point(s): Secondary safety endpoints:<br>- Presence of anti-HLA Abs and identification for donor HLA specificity<br>- Coagulation tests<br>- AEs reported up to Month 6 assessed for seriousness, severity, relationship to the IMP and/or IMP administration procedure. This includes but is not limited to clinically changes in clinical examinations, vital signs, laboratory tests and imaging <br><br>Preliminary efficacy endpoints:<br>- Composite score for disease stage: MELD, Child-Pugh scores and CLIF-CAD (for F4 decompensated)<br>- Quantitative assessment of liver and metabolic function<br>- Quantitative assessment of Liver fibrosis biomarkers<br>- Quantitative assessment of Liver stiffness<br><br>Exploratory endpoints:<br>- Number of new/new onset of acute decompensation events<br>- In vitro proliferative and cytokine secretion function of PBMC in response to TetT, PPD, and PHA<br>- In vitro T cell response to HepaStem<br>- Quantitative assessment of inflammatory, apoptosis, and NASH biomarkers from baseline to up to 6 months after last infusion<br>- Quantitative assessment of Portal hypertension biomarkers<br>- Day 28 assessed for seriousness, severity, relationship to the IMP and/or IMP administration procedure. This includes inflammation scores evaluated on Liver histology prior and 6 months post infusion<br><br>Sub-study endpoints:<br>- Quantitative assessment of HPVG prior and 6 months post infusion<br>- Quantitative assessment of NAS, SAF score, METAVIR scores
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| Sponsor/Collaborators: |
Promethera Biosciences
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| Gender: |
All
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| Age: |
nannan
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| Phases: |
Phase 2
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| Enrollment: |
24
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| Study Type: |
Interventional clinical trial of medicinal product
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| Study Designs: |
Controlled: no<br>Randomised: no<br>Open: yes<br>Single blind: no<br>Double blind: no<br>Parallel group: no<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: no<br>Other: no<br>Number of treatmen
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| Start Date: |
27/12/2018
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| Completion Date: |
--
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| Results First Posted: |
--
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| Last Update Posted: |
23 November 2020
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| Locations: |
France;Spain;Poland;Belgium;Bulgaria;Switzerland
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| URL: |
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2018-004449-18
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