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More info
You can access this
clinical trial
if you have
Liver Failure, Acute
and you are
between 18 and 65
years old
2
This is a second phase trial assessing
efficacy and side effects of the new treatment.
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The purpose

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.

Provided treatments

  • Drug: ALF-5755
  • Drug: Saline solution (0.9% NaCl)

Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT01318525. The sponsor of the trial is Alfact Innovation and it is looking for 60 volunteers for the current phase.
Official trial 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