Study to Evaluate the Efficacy and Safety of HepaStem in Patients With Acute on Chronic Liver Failure (ACLF) (DHELIVER)

May 21, 2024 updated by: Cellaion SA

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
133

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Medical University of Vienna
  • Belgium
      • Antwerp, Belgium
        • UZ Antwerpen
      • Brussels, Belgium
        • CHU Brugmann
      • Brussels, Belgium
        • CHU Erasme
      • Gent, Belgium, 9000
        • Universitair Ziekenhuis Gent
      • Leuven, Belgium
        • UZ Leuven
      • Liège, Belgium
        • Chc Montlegia
      • Woluwe-Saint-Lambert, Belgium
        • Cliniques universitaires Saint-Luc
  • Bulgaria
      • Pleven, Bulgaria
        • University Multiprofile Hospital for Active Treatment "Dr. Georgi Stranski"
      • Ruse, Bulgaria
        • UMHAT Medica
      • Sofia, Bulgaria
        • Military Medical Academy
      • Sofia, Bulgaria
        • UMHAT Sveta Anna
      • Sofia, Bulgaria
        • UMHAT Tzarita Joanna
  • Denmark
      • Aarhus, Denmark, 8200
        • Aarhus University Hospital
  • Estonia
      • Tallinn, Estonia, 13419
        • North Estonia Regional Hospital
      • Tallinn, Estonia
        • Lääne-Tallinna Keskhaigla AS
  • France
      • Angers, France
        • CHU Angers
      • Clichy, France
        • Hôpital Beaujon
      • Créteil, France, 94000
        • Assistance Publique Hopitaux De Paris
      • Grenoble, France, 38043
        • Centre Hospitalier Universitaire Grenoble Alpes
      • Lyon, France
        • Hospices Civils de Lyon
      • Marseille, France
        • Assistance Publique Hôpitaux de Marseille
      • Montpellier, France
        • CHU Montpellier
      • Paris, France
        • Assistance Publique-Hopitaux de Paris - Hopitaux Universitaires Pitie-Salpetriere
      • Strasbourg, France
        • Les Hôpitaux Universitaires de Strasbourg
      • Toulouse, France, 31059
        • CHU de Toulouse
      • Villejuif, France, 94804
        • Hospital Paul Brousse
  • Germany
      • Hanover, Germany, 30625
        • Medizinische Hochschule Hannover
      • Leipzig, Germany, 04103
        • University Hospital of Leipzig
      • Ulm, Germany, 89081
        • University Hospital Of Ulm AöR
  • Italy
      • Milan, Italy, 20162
        • Azienda Ospedaliera Ospedale Niguarda Ca' Granda
      • Palermo, Italy, 90127
        • Azienda Ospedaliera Universitaria Policlinico
      • Udine, Italy, 33100
        • Azienda Sanitaria Universitaria Friuli Centrale
  • Latvia
      • Riga, Latvia, 1002
        • Pauls Stradins Clinical University Hospital
  • Lithuania
      • Kaunas, Lithuania, 50161
        • Lietuvos Sveikatos Mokslų Universiteto Ligoninė Kauno Klinikos
  • North Macedonia
      • Skopje, North Macedonia, 1000
        • PHI General City Hospital "8mi Septemvri"
      • Skopje, North Macedonia, 1000
        • PHI University Clinic of Gastroenterohepatology
  • Poland
      • Mysłowice, Poland, 41-400
        • ID Clinic
      • Rzeszów, Poland, 35-301
        • Kliniczny Szpital Wojewódzki Nr 2 im. Św. Jadwigi Królowej w Rzeszowie
  • Slovakia
      • Banská Bystrica, Slovakia, 974 01
        • F.D. Roosevelt University General Hospital Of Banská Bystrica
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron
      • Córdoba, Spain, 14004
        • Hospital Universitario Reina Sofia
      • Madrid, Spain, 28049
        • University Hospital Ramon y Cajal
      • Majadahonda, Spain, 28222
        • Hospital Universitario Puerta de Hierro de Majadahonda
      • Sabadell, Spain, 08208
        • Sabadell Hospital
      • Zaragoza, Spain, 50009
        • Hospital Clinico Universitario Lozano Blesa
      • Zaragoza, Spain, 50009
        • Hospital Unviersitario Miguel Servet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Are adults aged between 18 and 75 years old.
  2. Have an initial diagnosis of ACLF at the investigational site.
  3. Have ACLF grade 1 or 2 according to the EASL-CLIF Consortium definition.
  4. Have a total bilirubin ≥ 5 mg/dL.
  5. Are able to read, understand and give written informed consent.

Main Exclusion Criteria:

  1. Have a MELD-Na score > 35.
  2. Have underlying cirrhosis due to biliary disease.
  3. Have underlying cirrhosis due to autoimmune hepatitis.
  4. 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.
  5. 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.
  6. Have a complete portal vein thrombosis.

  7. Have coagulation disturbances defined as:

    • fibrinogen < 80 mg/dL
    • platelets < 50 x 10³/mm³
  8. Are requiring chronic dialysis therapy.
  9. 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.
  10. Have a previous history of myocardial infarction and/or cardiac failure, with an ejection fraction rate (EFR) ≤ 40%.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Patients in the placebo arm will receive 2 infusions of placebo (i.v) (7 day interval)
Drug: Placebo
Placebo will be administered as an intravenous (IV) infusion
Experimental: HepaStem
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)
Drug: HepaStem
HepaStem will be administered as an intravenous (IV) infusion

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Day 90

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Liver transplant-free survival
Time Frame: Day 90
Day 90
Transplant-free survival while free of ACLF
Time Frame: Day 90
Day 90
Transplant-free survival with MELD-Na score < 15
Time Frame: Day 90
Day 90
Duration of overall hospitalization and hospitalization in ICU and non-ICU during the index hospitalization
Time Frame: up to Day 90
up to Day 90

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cellaion SA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 21, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 10, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 10, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 6, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 11, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 18, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 22, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 21, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HEP102

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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