NCT01318525

Efficacy & Safety of ALF-5755 in Patients With Nonacetaminophen Severe Acute Hepatitis & Early Stage Acute Liver Failure

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Alfact Innovation · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Liver Failure, Acute

Interventions

Type	Name	Description
DRUG	ALF-5755	10 mg (25 ml) given in slow intravenous infusion over 10 minutes with an automatic syringe
DRUG	Saline solution (0.9% NaCl)	25 ml given in slow intravenous infusion over 10 minutes with an automatic syringe

Timeline

• Start date: 2010-10-01
• Primary completion: 2012-05-01
• Completion: 2012-09-01
• First posted: 2011-03-18
• Last updated: 2011-04-05

Locations

12 sites across 1 country: France