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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
10 mg (25 ml) given in slow intravenous infusion over 10 minutes with an automatic syringe
25 ml given in slow intravenous infusion over 10 minutes with an automatic syringe
CHU de Besançon
Besançon, France
NOT_YET_RECRUITINGCHU Clermont-Ferrand
Clermont-Ferrand, France
NOT_YET_RECRUITINGHôpital Beaujon
Clichy, France
RECRUITINGCHU de Grenoble
Grenoble, France
RECRUITINGHôpital Claude Huriez
Lille, France
NOT_YET_RECRUITINGHôpital Croix-Rousse
Lyon, France
RECRUITINGHôpital Conception
Marseille, France
NOT_YET_RECRUITINGHôpital Saint-Eloi
Montpellier, France
RECRUITINGHôpital de l'Archet 2
Nice, France
NOT_YET_RECRUITINGHôpital Saint Antoine
Paris, France
RECRUITING...and 2 more locations
Rate of change of Prothrombin Rate initiation
Time frame: Over a period of 72 hours from baseline
Rate of change of Factor V (FV) plasma level
Time frame: Over a period of 72 hours from baseline
Rate of change of international normalized ratio (INR)
Time frame: Over a period of 72 hours from baseline
Rate of change of alanine transaminases (ALT) plasma level
Time frame: Over a period of 72 hours from baseline
Rate of change of aspartate transaminases (AST) plasma level
Time frame: Over a period of 72 hours from baseline
Change of Hepatic Encephalopathy Grade (HE grade)
Time frame: Over a period of 72 hours from baseline
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.