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

Study Status: Not yet recruiting
Recruit Status: Unknown status
Study Type: Interventional

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

Brief 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.


Detailed Summary:
Sponsor: Alfact Innovation

Current Primary Outcome: Rate of change of Prothrombin Rate initiation [ Time Frame: Over a period of 72 hours from baseline ]

Original Primary Outcome: Rate of change of Prothrombin Rate initiation [ Time Frame: 72 hours ]

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome:

  • Rate of change of Factor V (FV) plasma level [ Time Frame: 72 hours ]
  • Rate of change of international normalized ratio (INR) [ Time Frame: 72 hours ]
  • Rate of change of alanine transaminases (ALT) plasma level [ Time Frame: 72 hours ]
  • Rate of change of aspartate transaminases (AST) plasma level [ Time Frame: 72 hours ]
  • Change of Hepatic Encephalopathy Grade (HE grade) [ Time Frame: 72 hours ]


Information By: Alfact Innovation

Dates:
Date Received: March 17, 2011
Date Started: October 2010
Date Completion: September 2012
Last Updated: April 4, 2011
Last Verified: April 2011