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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2015 by Madaus Inc
Information provided by (Responsible Party):
Madaus Inc Identifier:
First received: June 4, 2009
Last updated: September 21, 2015
Last verified: September 2015

June 4, 2009
September 21, 2015
February 2010
December 2015   (final data collection date for primary outcome measure)
prevention of severe morbidity (liver transplantation) and death [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00915681 on Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • cutaneous reactions [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • sodium [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • hemoglobin [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
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.

Not Provided
Phase 2
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Amatoxin Poisoning
  • Amanita Poisoning
  • Mushroom Poisoning
  • Liver Failure
Drug: Legalon SIL (Silibinin)
20 mg/kg/day IV
Experimental: Legalon SIL
Legalon SIL
Intervention: Drug: Legalon SIL (Silibinin)
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2015
December 2015   (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
2 Years and older
Contact: Todd Mitchell, MD 831-479-7916
Contact: Joe Veilleux 412-279-8808
United States
Madaus Inc
Madaus Inc
Not Provided
Principal Investigator: Todd Mitchell, MD Dominican Santa Cruz Hospital
Madaus Inc
September 2015

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