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

Primary Purpose

Acute on Chronic Liver Failure

Status

Recruiting

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

HepaStem

Placebo

About this trial

This is an interventional treatment trial for Acute on Chronic Liver Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Main Inclusion Criteria:

Initial diagnostic of ACLF, at the investigational site, maximum 3 days before signature of the ICF.
Patient with Acute on Chronic Liver Failure Grade 1 or 2 according to the CLIF definition*.
Bilirubin value ≥5 mg/dL.

Main Exclusion Criteria:

ACLF grade 3.
Active uncontrolled bleeding or patient with high risk of short term bleeding up to investigator's judgment.
Model for End-Stage Liver Disease (MELD) score >35.
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.
Mechanical ventilation due to respiratory failure, except for hepatic encephalopathy.
Inability to maintain mean BP >60 despite use of vasopressors.
Patients receiving immunosuppressive drugs, except glucocorticoids.
Thrombosis of portal vein.
Underlying cirrhosis due to biliary disease or auto immune hepatitis
Coagulation disturbances defined as (Drolz et al. 2016; Nadim et al. 2016):
1. fibrinogen <80 mg/dL
2. platelets <50 x 10³/mm3

Sites / Locations

CHU BrugmannRecruiting
CHU ErasmeRecruiting
KU LeuvenRecruiting
University Multiprofile Hospital for Active Treatment "Dr. Georgi Stranski"Recruiting
UMBAL Medica
MMA-SofiaRecruiting
UMHAT Sveta Anna
UMHAT Tzarita Joanna

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

HepaStem

Placebo

Arm Description

Patients in the HepaStem arm will receive 2 infusions of HepaStem (i.v) at 1.0 millions of cells/kg (7 day interval)

Patients in the placebo arm will receive 2 infusions of placebo (i.v) (7 day interval)

Outcomes

Primary Outcome Measures

Overall Survival proportion 90 days post-first infusion.

Overall Survival proportion

Secondary Outcome Measures

Transplant-free survival proportion 90 days post-first infusion.

Liver Transplant-free survival proportion

Liver function parameters up to 1-year post-infusion

CLIF-C ACLF score

Liver function parameters up to 1-year post-infusion

MELD score

Full Information

NCT ID

NCT04229901

First Posted

January 6, 2020

Last Updated

December 31, 2021

Sponsor

Cellaion SA

1. Study Identification

Unique Protocol Identification Number

NCT04229901

Brief Title

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

Acronym

DHELIVER

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2021

Overall Recruitment Status

Recruiting

Study Start Date

January 21, 2020 (Actual)

Primary Completion Date

January 2023 (Anticipated)

Study Completion Date

January 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cellaion SA

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This is an interventional, double blind, randomized (2:1), and placebo-controlled study of 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute on Chronic Liver Failure

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

363 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

HepaStem

Arm Type

Experimental

Arm Description

Patients in the HepaStem arm will receive 2 infusions of HepaStem (i.v) at 1.0 millions of cells/kg (7 day interval)

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Patients in the placebo arm will receive 2 infusions of placebo (i.v) (7 day interval)

Intervention Type

Drug

Intervention Name(s)

HepaStem

Intervention Description

HepaStem will be administered as an intravenous (IV) infusion

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo will be administered as an intravenous (IV) infusion

Primary Outcome Measure Information:

Title

Overall Survival proportion 90 days post-first infusion.

Description

Overall Survival proportion

Time Frame

90 days post first infusion

Secondary Outcome Measure Information:

Title

Transplant-free survival proportion 90 days post-first infusion.

Description

Liver Transplant-free survival proportion

Time Frame

90 days post first infusion

Title

Liver function parameters up to 1-year post-infusion

Description

CLIF-C ACLF score

Time Frame

up to 1-year post first infusion.

Title

Liver function parameters up to 1-year post-infusion

Description

MELD score

Time Frame

up to 1-year post first infusion.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Main Inclusion Criteria: Initial diagnostic of ACLF, at the investigational site, maximum 3 days before signature of the ICF. Patient with Acute on Chronic Liver Failure Grade 1 or 2 according to the CLIF definition*. Bilirubin value ≥5 mg/dL. Main Exclusion Criteria: ACLF grade 3. Active uncontrolled bleeding or patient with high risk of short term bleeding up to investigator's judgment. Model for End-Stage Liver Disease (MELD) score >35. 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. Mechanical ventilation due to respiratory failure, except for hepatic encephalopathy. Inability to maintain mean BP >60 despite use of vasopressors. Patients receiving immunosuppressive drugs, except glucocorticoids. Thrombosis of portal vein. Underlying cirrhosis due to biliary disease or auto immune hepatitis Coagulation disturbances defined as (Drolz et al. 2016; Nadim et al. 2016): fibrinogen <80 mg/dL platelets <50 x 10³/mm3

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Virginie BARTHEL

Phone

+3210394300

virginie.barthel@promethera.com

Facility Information:

Facility Name

CHU Brugmann

City

Brussels

ZIP/Postal Code

1020

Country

Belgium

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Luc Lasser, MD

Facility Name

CHU Erasme

City

Brussels

ZIP/Postal Code

1070

Country

Belgium

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Thierry Gustot, MD, PhD

Facility Name

KU Leuven

City

Leuven

Country

Belgium

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Frederik Nevens, MD

Facility Name

University Multiprofile Hospital for Active Treatment "Dr. Georgi Stranski"

City

Pleven

Country

Bulgaria

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Desislava Lyubomirova, MD

Facility Name

UMBAL Medica

City

Ruse

Country

Bulgaria

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Venci Droganov

Facility Name

MMA-Sofia

City

Sofia

Country

Bulgaria

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Krum Katsarov, MD

Facility Name

UMHAT Sveta Anna

City

Sofia

Country

Bulgaria

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Bojidar Tomov, MD

Facility Name

UMHAT Tzarita Joanna

City

Sofia

Country

Bulgaria

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jordan Genov, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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