Acute on Chronic Liver FailurePhase 2DHELIVERNCT04229901
Study to Evaluate the Efficacy and Safety of HepaStem in Patients With Acute on Chronic Liver Failure (ACLF)
A Phase 2 study testing HepaStem in people with Acute on Chronic Liver Failure, run by Cellaion SA at 47 sites in 14 countries.
Trial summary
This is an interventional, double blind, randomized (2:1), and placebo-controlled study of 2 infusions of a 1 dose regimen of HepaStem in patients recently diagnosed (≤1 week) with ACLF grade 1 or 2 on top of Standard of Care (SoC), and for whom the diagnosis is not resolved on the day of infusion. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute on Chronic Liver Failure
- What is being tested?
- HepaStem
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 133 participants
- Where
- 47 sitesin 14 countries
- Study dates
- 21 Jan 2020to 10 May 2024
- Phase
- Phase 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Are adults aged between 18 and 75 years old.
- Have an initial diagnosis of ACLF at the investigational site.
- Have ACLF grade 1 or 2 according to the EASL-CLIF Consortium definition.
- Have a total bilirubin ≥ 5 mg/dL.
- Are able to read, understand and give written informed consent.
- Main Exclusion Criteria:
Show all 18Show fewer
- Have a MELD-Na score > 35.
- Have underlying cirrhosis due to biliary disease.
- Have underlying cirrhosis due to autoimmune hepatitis.
- Have active bleeding at a non-compressible site or at a compressible site that, in the opinion of the investigator, poses an unacceptable risk for the patient's participation in the study.
- Have received treatment for bleeding complications during the current hospitalization and has a persistent high risk for re-bleeding that, in the opinion of the investigator, poses an unacceptable risk for the patient's participation in the study.
- Have a complete portal vein thrombosis.
- Have coagulation disturbances defined as:
- fibrinogen < 80 mg/dL
- platelets < 50 x 10³/mm³
- Are requiring chronic dialysis therapy.
- Have had a cerebrovascular, myocardial, limb arterial thrombotic event, or history for both thrombotic and hemorrhagic cerebrovascular events within 12 months prior to the Screening and not considered stabilized by the investigator.
- Have a previous history of myocardial infarction and/or cardiac failure, with an ejection fraction rate (EFR) ≤ 40%.
Who cannot join
None listed.
Trial locations and contacts
47 sites in 14 countries.
47 sites in 14 countries
France11 sites
CHU Angers
Angers
Hopital Beaujon
Clichy
Assistance Publique Hopitaux De Paris
Créteil, 94000
Centre Hospitalier Universitaire Grenoble Alpes
Grenoble, 38043
Hospices Civils De Lyon
Lyon
Assistance Publique Hopitaux De Marseille
Marseille
CHU Montpellier
Montpellier
Assistance Publique-Hopitaux de Paris - Hopitaux Universitaires Pitie-Salpetriere
Paris
Les Hopitaux Universitaires De Strasbourg
Strasbourg
CHU De Toulouse
Toulouse, 31059
Hospital Paul Brousse
Villejuif, 94804
Belgium7 sites
UZ Antwerpen
Antwerp
CHU Brugmann
Brussels
CHU Erasme
Brussels
Universitair Ziekenhuis Gent
Ghent, 9000
UZ Leuven
Leuven
CHC MontLégia
Liège
Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert
Spain7 sites
Hospital Universitari Vall D'Hebron
Barcelona, 08035
Hospital Universitario Reina Sofia
Córdoba, 14004
University Hospital Ramón Y Cajal
Madrid, 28049
Hospital Universitario Puerta De Hierro De Majadahonda
Majadahonda, 28222
Sabadell Hospital
Sabadell, 08208
Hospital Clinico Universitario Lozano Blesa
Zaragoza, 50009
Hospital Unviersitario Miguel Servet
Zaragoza, 50009
Bulgaria5 sites
University Multiprofile Hospital for Active Treatment "Dr. Georgi Stranski"
Pleven
UMHAT Medica
Rousse
Military Medical Academy
Sofia
UMHAT Sveta Anna
Sofia
UMHAT Tzarita Joanna
Sofia
Germany3 sites
Medizinische Hochschule Hannover
Hanover, 30625
University Hospital Of Leipzig
Leipzig, 04103
University Hospital Of Ulm AöR
Ulm, 89081
Italy3 sites
Azienda Ospedaliera Ospedale Niguarda CA' Granda
Milan, 20162
Azienda Ospedaliera Universitaria Policlinico
Palermo, 90127
Azienda Sanitaria Universitaria Friuli Centrale
Udine, 33100
Estonia2 sites
North Estonia Regional Hospital
Tallinn, 13419
Lääne-Tallinna Keskhaigla AS
Tallinn
North Macedonia2 sites
PHI General City Hospital "8mi Septemvri"
Skopje, 1000
PHI University Clinic of Gastroenterohepatology
Skopje, 1000
Poland2 sites
Id Clinic
Mysłowice, 41-400
Kliniczny Szpital Wojewódzki Nr 2 Im. Św. Jadwigi Królowej W Rzeszowie
Rzeszów, 35-301
Lithuania1 site
Lietuvos Sveikatos Mokslų Universiteto Ligoninė Kauno Klinikos
Kaunas, 50161
Slovakia1 site
F.D. Roosevelt University General Hospital Of Banská Bystrica
Banská Bystrica, 974 01
About this study
Official title: Randomized, Placebo-controlled, Double Blind, Multi-centre Phase IIb Study to Evaluate the Efficacy and Safety of HepaStem in Patients With Acute on Chronic Liver Failure (ACLF
This is an interventional, double blind, randomized (2:1), and placebo-controlled study of 2 infusions of a 1 dose regimen of HepaStem in patients recently diagnosed (≤1 week) with ACLF grade 1 or 2 on top of Standard of Care (SoC), and for whom the diagnosis is not resolved on the day of infusion.
- Conditions
- Acute on Chronic Liver Failure
- Being tested
- HepaStem, Placebo
- Keywords
- ACLF, Hepastem, HALPC
- Medical subject headings
- Acute-On-Chronic Liver Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HepaStemDrug
HepaStem will be administered as an intravenous (IV) infusion
PlaceboDrug
Placebo will be administered as an intravenous (IV) infusion
| Study group | Role | What they receive |
|---|---|---|
| HepaStem | Experimental | Patients in the HepaStem arm will receive 2 infusions of HepaStem (i.v) at 1.0 million of cells/kg of total body weight (7 day interval) Receives: Drug: HepaStem |
| Placebo | Placebo comparator | Patients in the placebo arm will receive 2 infusions of placebo (i.v) (7 day interval) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Whether the patients are still alive will be recorded up to Day 90. Time and reason of death will be recorded.
Measured: Day 90
Secondary outcomes (4)
Liver transplant-free survival
Measured: Day 90
Transplant-free survival while free of ACLF
Measured: Day 90
Transplant-free survival with MELD-Na score < 15
Measured: Day 90
Duration of overall hospitalization and hospitalization in ICU and non-ICU during the index hospitalization
Measured: up to Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start21 Jan 2020
- Primary completion10 May 2024
- Study completion10 May 2024
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute on Chronic Liver FailureStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cellaion SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04229901
- Sponsor's protocol ID
- HEP102
- Acronym
- DHELIVER
- Status last verified
- May 2024
- First submitted
- 6 Jan 2020
- Last updated
- 22 May 2024
- 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 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Placebo-controlled, Double Blind, Multi-centre Phase IIb Study to Evaluate the Efficacy and Safety of HepaStem in Patients With Acute on Chronic Liver Failure (ACLF
- ClinicalTrials.gov ID
- NCT04229901
- Acronym / sponsor ID
- DHELIVER / HEP102
- Conditions
- Acute on Chronic Liver Failure
- Keywords
- ACLF, Hepastem, HALPC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Cellaion SAIndustry (pharma, biotech, devices)
- Study start
- 21 Jan 2020 (actual)
- Primary completion
- 10 May 2024 (actual)
- Study completion
- 10 May 2024 (actual)
- First posted
- 18 Jan 2020 (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.
This is an interventional, double blind, randomized (2:1), and placebo-controlled study of 2 infusions of a 1 dose regimen of HepaStem in patients recently diagnosed (≤1 week) with ACLF grade 1 or 2 on top of Standard of Care (SoC), and for whom the diagnosis is not resolved on the day of infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HepaStem | Experimental | Drug: HepaStemPatients in the HepaStem arm will receive 2 infusions of HepaStem (i.v) at 1.0 million of cells/kg of total body weight (7 day interval) |
| Placebo | Placebo comparator | Drug: PlaceboPatients in the placebo arm will receive 2 infusions of placebo (i.v) (7 day interval) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Are adults aged between 18 and 75 years old.
- Have an initial diagnosis of ACLF at the investigational site.
- Have ACLF grade 1 or 2 according to the EASL-CLIF Consortium definition.
- Have a total bilirubin ≥ 5 mg/dL.
- Are able to read, understand and give written informed consent.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| HepaStemHepaStem will be administered as an intravenous (IV) infusion | Drug | HepaStem |
| PlaceboPlacebo will be administered as an intravenous (IV) infusion | Drug | Placebo |
Primary outcome
Survival
Time frame: Day 90
Whether the patients are still alive will be recorded up to Day 90. Time and reason of death will be recorded.
4 secondary outcomes
Liver transplant-free survival
Time frame: Day 90
Transplant-free survival while free of ACLF
Time frame: Day 90
Transplant-free survival with MELD-Na score < 15
Time frame: Day 90
Duration of overall hospitalization and hospitalization in ICU and non-ICU during the index hospitalization
Time frame: up to Day 90
Results and safety
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2024.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Acute on Chronic Liver Failure
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Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
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CytOSorb TreatMent Of Critically Ill PatientS Registry
Septic Shock, Acute Respiratory Distress Syndrome
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Very Low-volume Plasma Exchange in ACLF
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Recruiting
A Novel Extracorporeal Liver Support Therapy In ALCF and to Evaluate the Efficacy of DIALIVE 2.0, a Liver Dialysis Device.
Acute-on-Chronic Liver Failure (ACLF), Liver Cirrhosis
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.
The record lists no contact. Use the official record to reach the sponsor.
47 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HepaStem in people with Acute on Chronic Liver Failure, run by Cellaion SA at 47 sites in 14 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 0 exclusion criteria. 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: stopped early, as of the sponsor's last update on 22 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 sites in France, Belgium, Spain, Bulgaria, Germany and 9 more countries. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
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 was stopped early (reason given: Sponsor decision). Results are not available in the source record.
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?
Survival (time frame: Day 90). 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 22 May 2024.