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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT00915681
Recruitment Status : Recruiting
First Posted : June 8, 2009
Last Update Posted : December 26, 2017
Mylan Inc.
Information provided by (Responsible Party):
Madaus Inc

June 4, 2009
June 8, 2009
December 26, 2017
February 2010
December 31, 2018   (Final data collection date for primary outcome measure)
percentage of patients survived without liver transplantation [ Time Frame: 1 month ]
prevention of severe morbidity (liver transplantation) and death [ Time Frame: 1 month ]
Complete list of historical versions of study NCT00915681 on Archive Site
Not Provided
  • Improvement in presenting abnormalities as evaluated by time to normality for hepatic and renal function tests (AST, ALT, bilirubin, PT/INR, creatinine). [ Time Frame: 1 month ]
  • cutaneous reactions [ Time Frame: 1 month ]
  • sodium [ Time Frame: 1 month ]
  • hemoglobin [ Time Frame: 1 month ]
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Intravenous Milk Thistle (Silibinin-Legalon) for Hepatic Failure Induced by Amatoxin/Amanita Mushroom Poisoning
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.
Phase 2
Phase 3
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Amatoxin Poisoning
  • Amanita Poisoning
  • Mushroom Poisoning
  • Liver Failure
Drug: Silibinin
20 mg/kg/day IV
Other Name: Legalon SIL
Experimental: Legalon SIL
Silibinin: loading dose of one hour infusion of 5 mg/kg, followed by 20 mg/kg/day infused continuously via pump
Intervention: Drug: Silibinin
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 31, 2018
December 31, 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
2 Years and older   (Child, Adult, Senior)
Contact: Kathleen Baker, BSN 304-288-4935
Contact: Wallis Marsh, MD 412-522-4334
United States
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Madaus Inc
Madaus Inc
Mylan Inc.
Principal Investigator: Wallis Marsh, MD WVU
Madaus Inc
December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP