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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 April 2017 by Madaus Inc
Mylan Inc.
Information provided by (Responsible Party):
Madaus Inc Identifier:
First received: June 4, 2009
Last updated: April 3, 2017
Last verified: April 2017
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.

Condition Intervention Phase
Amatoxin Poisoning
Amanita Poisoning
Mushroom Poisoning
Liver Failure
Drug: Silibinin
Phase 2
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Prevention and Treatment of Amatoxin Induced Hepatic Failure With Intravenous Silibinin ( Legalon® SIL): An Open Multicenter Clinical Trial

Resource links provided by NLM:

Further study details as provided by Madaus Inc:

Primary Outcome Measures:
  • percentage of patients survived without liver transplantation [ Time Frame: 1 month ]

Estimated Enrollment: 50
Study Start Date: February 2010
Estimated Study Completion Date: December 31, 2018
Estimated Primary Completion Date: December 31, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Legalon SIL
Silibinin: loading dose of one hour infusion of 5 mg/kg, followed by 20 mg/kg/day infused continuously via pump
Drug: Silibinin
20 mg/kg/day IV
Other Name: Legalon SIL

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

Ages Eligible for Study:   2 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00915681

Contact: Todd Mitchell, MD 831-479-7916
Contact: Gail L Tribble, BSN 412-651-9530

United States, California
Dominican Santa Cruz Hospital Recruiting
Santa Cruz, California, United States, 95065
Contact: Todd Mitchell, MD    831-479-7916   
Principal Investigator: Todd Mitchell, MD         
United States, New Jersey
Recruitment Hot Line for the United States Recruiting
Somerset, New Jersey, United States, 08873
Contact: Todd Mitchell, MD    866-520-4412      
Sponsors and Collaborators
Madaus Inc
Mylan Inc.
Principal Investigator: Todd Mitchell, MD Dominican Santa Cruz Hospital
  More Information

Responsible Party: Madaus Inc Identifier: NCT00915681     History of Changes
Other Study ID Numbers: SB16A1.07
Study First Received: June 4, 2009
Last Updated: April 3, 2017

Keywords provided by Madaus Inc:
mushroom poisoning
hepatic failure
milk thistle

Additional relevant MeSH terms:
Liver Failure
Mushroom Poisoning
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Chemically-Induced Disorders
Foodborne Diseases
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs processed this record on April 28, 2017