COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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. Read our disclaimer for details. Identifier: NCT00915681
Recruitment Status : Unknown
Verified December 2017 by Madaus Inc.
Recruitment status was:  Recruiting
First Posted : June 8, 2009
Last Update Posted : October 30, 2018
Mylan Inc.
Information provided by (Responsible Party):
Madaus Inc

Brief Summary:
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 or disease Intervention/treatment Phase
Amatoxin Poisoning Amanita Poisoning Mushroom Poisoning Liver Failure Drug: Silibinin Phase 2 Phase 3

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prevention and Treatment of Amatoxin Induced Hepatic Failure With Intravenous Silibinin ( Legalon® SIL): An Open Multicenter Clinical Trial
Study Start Date : February 2010
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Poisoning
Drug Information available for: Silymarin

Arm Intervention/treatment
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

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00915681

Layout table for location contacts
Contact: Judy Sherry 866-520-4412
Contact: Wallis Marsh, MD 866-520-4412

Layout table for location information
United States, New Jersey
Recruitment Hot Line for the United States Recruiting
Somerset, New Jersey, United States, 08873
Contact: Judy Sherry, BSN    866-520-4412      
United States, Pennsylvania
Mylan Recruiting
Canonsburg, Pennsylvania, United States, 15317
Contact: Ketty Belizaire    908-566-8260   
Contact: Gail Tribble    412-651-9530   
Sponsors and Collaborators
Madaus Inc
Mylan Inc.
Layout table for investigator information
Principal Investigator: Wallis Marsh, MD WVU
Layout table for additonal information
Responsible Party: Madaus Inc Identifier: NCT00915681    
Other Study ID Numbers: SB16A1.07
First Posted: June 8, 2009    Key Record Dates
Last Update Posted: October 30, 2018
Last Verified: December 2017
Keywords provided by Madaus Inc:
mushroom poisoning
hepatic failure
milk thistle
Additional relevant MeSH terms:
Layout table for MeSH terms
Liver Failure
Hepatic Insufficiency
Mushroom Poisoning
Liver Diseases
Digestive System Diseases
Chemically-Induced Disorders
Foodborne Diseases
Protective Agents
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Antineoplastic Agents