Trials / Terminated
TerminatedNCT04229901
Study to Evaluate the Efficacy and Safety of HepaStem in Patients With Acute on Chronic Liver Failure (ACLF)
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
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 133 (actual)
- Sponsor
- Cellaion SA · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | HepaStem | HepaStem will be administered as an intravenous (IV) infusion |
| DRUG | Placebo | Placebo will be administered as an intravenous (IV) infusion |
Timeline
- Start date
- 2020-01-21
- Primary completion
- 2024-05-10
- Completion
- 2024-05-10
- First posted
- 2020-01-18
- Last updated
- 2024-05-22
Locations
47 sites across 14 countries: Austria, Belgium, Bulgaria, Denmark, Estonia, France, Germany, Italy, Latvia, Lithuania, North Macedonia, Poland, Slovakia, Spain
Source: ClinicalTrials.gov record NCT04229901. Inclusion in this directory is not an endorsement.