Clinical trial to investigate the efficacy and safety of allo-APZ2-ACLF administered intravenously to patients suffering from acute-on-chronic liver failure.
- Conditions
- Acute-on-Chronic Liver FailureMedDRA version: 20.0Level: PTClassification code 10077305Term: Acute on chronic liver failureSystem Organ Class: 10019805 - Hepatobiliary disordersTherapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2018-001240-61-DE
- Lead Sponsor
- RHEACELL GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 18
1. Male or female patients, aged 20 to 75 years;
2. Diagnosed ACLF of grade 2 or 3 according to EASL-CLIF definition;
3. Patients are not eligible for liver transplant (confirmed by transplantation board);
4. Historical confirmed histology result of liver biopsy or other diagnostic methods (like medical imaging such as computed tomography, ultrasound ect.) to exclude other liver diseases;
5. Women of childbearing potential must have a negative blood pregnancy test at screening;
6. Women of childbearing potential and fertile man, and their partners must be willing to use highly effective contraceptive methods during the course of the clinical trial;
7. Written informed consent from patient, legal or authorized representative or a confirmation of justification of trial participation by an independent medical consultant. In case of confirmation by the independent medical consultant, a deferred informed consent from patient, legal or authorized representative has to be given.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 9
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 9
1. Patients without cirrhosis;
2. Patients with ACLF grade 1 according to EASL-CLIF definition;
3. Patient with septic shock;
4. Patients with known hepatopulmonal syndrome (HPS);
5. Patients with known pulmonary embolism that needs anticoagulative treatment;
6. Patients with pre-existing lung disease with necessity of respiratory support;
7. Active malignancy or history of malignancy within 5 years prior to trial entry;
8. Known infection with human immunodeficiency virus (HIV?1, HIV-2);
9. Any known allergies to components of the IMP;
10. Current or previous (within 30 days of enrolment) treatment with another IMP, or participation and/or under follow-up in another clinical trial;
11. Patients anticipated to be unwilling or unable to comply with the requirements of the protocol;
12. Evidence of any other medical conditions (such as psychiatric illness, physical examination, or laboratory findings) that may interfere with the planned treatment, affect the patient’s compliance, or place the patient at high risk of complications related to the treatment;
13. Pregnant or nursing women;
14. Employees of the sponsor, or employees or relatives of the investigator.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The aim of this clinical trial is to investigate the efficacy (by changes in Model for End-Stage Liver Disease [MELD] score) and safety (by monitoring adverse events [AEs]) of three doses of the IMP allo-APZ2-ACLF administered intravenously to patients suffering from ACLF.;Secondary Objective: Not applicable.;Primary end point(s): 1. Primary efficacy endpoint: Change of MELD score at Week 24 or last available post-baseline measurement if the Week 24 score is missing (last observation carried forward [LOCF]).<br><br>2. Primary safety endpoint: Adverse events.;Timepoint(s) of evaluation of this end point: 1. Screening, Day 0, Week 24, or last available post-baseline measurement of Days 4 or 11 or Weeks 3, 4, 8, 12, 16 or 20 if the Week 24 measurement is missing [LOCF].<br><br>2. A priori specification not possible; between Screening and Month 24.
- Secondary Outcome Measures
Name Time Method