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

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ClinicalTrials.gov 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

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
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
U.S. FDA Resources

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

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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

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 ClinicalTrials.gov identifier (NCT number): NCT00915681

Contact: Kathleen Baker, BSN 304-288-4935
Contact: Wallis Marsh, MD 412-522-4334

United States, New Jersey
Recruitment Hot Line for the United States Recruiting
Somerset, New Jersey, United States, 08873
Contact: Kathleen Baker, BSN    866-520-4412      
United States, Pennsylvania
Mylan Recruiting
Canonsburg, Pennsylvania, United States, 15317
Contact: Ketty Belizaire    908-566-8260    ketty.belizaire@mylan.com   
Contact: Gail Tribble    412-651-9530    gail.tribble@mylan.com   
Sponsors and Collaborators
Madaus Inc
Mylan Inc.
Principal Investigator: Wallis Marsh, MD WVU

Responsible Party: Madaus Inc
ClinicalTrials.gov Identifier: NCT00915681     History of Changes
Other Study ID Numbers: SB16A1.07
First Posted: June 8, 2009    Key Record Dates
Last Update Posted: December 26, 2017
Last Verified: December 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