Intravenous Milk Thistle (Silibinin-Legalon) for Hepatic Failure Induced by Amatoxin/Amanita Mushroom Poisoning



Status:Recruiting
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:2 - Any
Updated:11/1/2018
Start Date:February 2010
End Date:December 31, 2018
Contact:Judy Sherry
Phone:866-520-4412

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Prevention and Treatment of Amatoxin Induced Hepatic Failure With Intravenous Silibinin ( Legalon® SIL): An Open Multicenter Clinical Trial

Legalon® SIL will be administered to patients with amatoxin poisoning diagnosed by history,
gastrointestinal symptoms, elevated liver enzymes, and/or diagnostic assay (should one become
available). Patients may or may not also demonstrate abnormalities in bilirubin and/or
creatinine. Treatment consists of a 5 mg/kg loading dose followed by 20 mg/kg/day via
continuous infusion. The treating physician is expected to administer supportive therapy of
his/her choosing but consistent with best practices. Legalon® SIL will be stopped when
coagulopathy is no longer present, and when liver function tests have returned significantly
towards the normal range. Patients will be followed 7-14 days after the end of Legalon® SIL
therapy with follow up lab studies.

Patients with suspected amatoxin poisoning are reviewed for enrollment in the study by
contacting the Legalon SIL study hotline (866) 520-4412.

Inclusion Criteria:

- History of eating foraged mushrooms

- Gastrointestinal symptoms suggestive of amatoxin poisoning (cramping abdominal pain,
nausea, vomiting, and / or watery diarrhea) within 48 hrs of mushroom ingestion

- Liver function tests suggestive of amatoxin poisoning: AST or ALT above the upper
limit of normal within 48 hrs after mushroom ingestion

- Gender: male or female

- Age: > 2 yr
We found this trial at
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1000 Mylan Boulevard
Canonsburg, Pennsylvania 15317
Phone: 908-566-8260
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Somerset, New Jersey 08873
Phone: 866-520-4412
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