NASH - Nonalcoholic SteatohepatitisPhase 1/2PANASHNCT03963921
Safety and Tolerability of HepaStem in Patients With Cirrhotic and Pre-cirrhotic NASH Patients
A Phase 1/2 study testing HepaStem in people with NASH - Nonalcoholic Steatohepatitis, run by Cellaion SA at 13 sites in 4 countries.
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- NASH - Nonalcoholic Steatohepatitis
- What is being tested?
- HepaStem
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 13 sitesin 4 countries
- Study dates
- 9 Apr 2019to 31 Aug 2020
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
13 sites in 4 countries.
13 sites in 4 countries
Belgium4 sites
CUB Erasme
Brussels, 1070
Cliniques Universitaires St Luc
Brussels, 1200
University Hospital Antwerp (UZA)
Edegem, 2650
UZ Gent
Ghent, 9000
Spain4 sites
Vall d'Hebron
Barcelona, 08035
Hospital de la Santa Creu i Sant Pau
Barcelona, 08041
Hospital General Universitario Gregorio Marañon
Madrid, 28007
Hospital Universitario Ramón y Cajal
Madrid, 28034
Bulgaria3 sites
University Multiprofile Hospital for Active Treatment "Tsaritsa Yoana - ISUL"
Sofia, 1527
Multiprofile hospital for active treatment (MHAT) Sofia Military Medical Academy
Sofia, 1606
Trakia Park Hospital
Stara Zagora, 6004
France2 sites
CHU Bordeaux
Bordeaux, 33604
Paul Brousse Hospital
Villejuif, 94804
About this study
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)
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)
- Conditions
- NASH - Nonalcoholic Steatohepatitis
- Being tested
- HepaStem
- Keywords
- NASH
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HepaStemDrug
Heterologous human adult liver-derived progenitor cells
| Study group | Role | What they receive |
|---|---|---|
| F4 patient population | Experimental | A total of 2 doses are planned to be administered as single or repeated infusions in an ascending manner: Receives: 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: Receives: Drug: HepaStem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Event
Safety and Tolerability
Measured: up to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2019
- Study start9 Apr 2019
- Primary completion28 May 2020
- Study completion31 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NASH - Nonalcoholic SteatohepatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cellaion SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Etienne SOKAL, MD, PhD, Study chair, CSMO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03963921
- Sponsor's protocol ID
- HEP201
- Acronym
- PANASH
- Status last verified
- Oct 2020
- First submitted
- 23 May 2019
- Last updated
- 14 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03963921
- Acronym / sponsor ID
- PANASH / HEP201
- Conditions
- NASH - Nonalcoholic Steatohepatitis
- Keywords
- NASH
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Cellaion SAIndustry (pharma, biotech, devices)
- Study start
- 9 Apr 2019 (actual)
- Primary completion
- 28 May 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 28 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| F4 patient population | Experimental | Drug: HepaStemA total of 2 doses are planned to be administered as single or repeated infusions in an ascending manner: |
| F3 patient population | Experimental | Drug: HepaStemA total of 2 doses are planned to be administered as single or repeated infusions in an ascending manner: |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HepaStemHeterologous human adult liver-derived progenitor cells | Drug | F3 patient population, F4 patient population |
Primary outcome
Incidence of Adverse Event
Time frame: up to Day 28
Safety and Tolerability
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Etienne SOKAL, MD, PhD study chair
CSMO
13 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing HepaStem in people with NASH - Nonalcoholic Steatohepatitis, run by Cellaion SA at 13 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Belgium, Spain, Bulgaria, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Event (time frame: up to Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2020.