Liver Failure, Acute Clinical Trial
Official title:
A Multicentre, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy and the Safety of ALF-5755 in Patients With Nonacetaminophen Severe Acute Hepatitis and Early Stage Acute Liver Failure
Acute liver failure is a rare but dramatic disease, often affecting young people, marked by
the sudden loss of liver function in a person without preexisting liver disease.
ALF-5755 has been shown to promote cell survival after apoptotic or oxidative stress, and
liver cell regeneration in primary cultures and in vivo. ALF-5755 may become, in this
dramatic disease with high unmet medical need, a future therapy for the treatment of
patients suffering from severe acute hepatitis (SAH) and acute liver failure (ALF) not due
to acetaminophen overdose, where liver transplantation is the sole treatment in the absence
of spontaneous recovery.
The primary objective of the study is to evaluate the efficacy of ALF-5755 versus placebo.
A minimum of 60 patients will be recruited into the study in the following two treatment
groups:
- Group A: approximately 30 patients will receive ALF-5755
- Group B: approximately 30 patients will receive placebo (physiological saline solution:
0.9% NaCl)
Patients will receive 10 mg (25 ml) of ALF5755 or placebo every 12 hours over 3 days in slow
intravenous infusions over 10 minutes using automatic syringes.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT00225901 -
Phase I/II Study of Recombinant Human Hepatocyte Growth Factor in Fulminant Hepatic Failure
|
Phase 1/Phase 2 | |
| Not yet recruiting |
NCT05778461 -
Efficacy of L-ornithine L-aspartate and Therapeutic Plasma Exchange Versus Plasma Exchange Alone in Lowering Ammonia and Improving Outcomes in Pediatric Acute Liver Failure.
|
N/A | |
| Completed |
NCT03312036 -
HEpatic Regeneration With COupled Plasma Filtration and Adsorption for Liver Extracorporeal Detoxification
|
N/A | |
| Not yet recruiting |
NCT03084198 -
Safety and Efficacy of hiHep Bioartificial Liver Support System to Treat Acute Liver Failure
|
N/A | |
| Recruiting |
NCT01341951 -
Granulocyte Colony Stimulating Factor (G-CSF) in Acute Liver Failure and Alcoholic Hepatitis
|
N/A | |
| Not yet recruiting |
NCT05473403 -
Validation of a Prognostic Score for Steroid Therapy Response in Acute Severe Autoimmune Hepatitis
|
N/A | |
| Completed |
NCT04959110 -
Citrate Pharmacokinetics in Critically Ill Liver Failure Patients Receiving CRRT
|
N/A | |
| Enrolling by invitation |
NCT01471262 -
Right Hepatectomy in Patients Beyond 70 Years Old
|
N/A | |
| Recruiting |
NCT06263114 -
Correlation of Blood Gene Expression (TruGraf Liver) With Liver Biopsy in Pediatric Liver Transplant Recipients
|
||
| Completed |
NCT04512014 -
Perioperative Lactate Kinetics in Patient Undergoing Major Liver Surgery
|
||
| Completed |
NCT02687763 -
Safety and Efficacy of ProQuad® in Children 6-24 Month Being Evaluated for Solid Organ Transplant
|
Early Phase 1 | |
| Completed |
NCT02310542 -
Comparison of Two Liver Dialysis Systems : MARS Versus SPAD in Severe Liver Failure
|
N/A | |
| Completed |
NCT01394497 -
Use of N-Acetylcysteine During Liver Procurement
|
Phase 2 | |
| Completed |
NCT01878305 -
Neuromonitoring of Hepatic Encephalopathy
|
N/A | |
| Not yet recruiting |
NCT05817994 -
Endoscopic Ultrasound Guided Liver Biopsy and Portal Pressure Registry
|
||
| Withdrawn |
NCT01137591 -
Acetaminophen in Combination With N-Acetylcysteine (NAC) Versus Placebo in Treating Fever
|
N/A |