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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 : October 30, 2018
Sponsor:
Collaborator:
Mylan Inc.
Information provided by (Responsible Party):
Madaus Inc

Study Description
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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 Design
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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

Arms and Interventions
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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


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

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

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
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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


Contacts
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Contact: Judy Sherry 866-520-4412
Contact: Wallis Marsh, MD 866-520-4412

Locations
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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    ketty.belizaire@mylan.com   
Contact: Gail Tribble    412-651-9530    gail.tribble@mylan.com   
Sponsors and Collaborators
Madaus Inc
Mylan Inc.
Investigators
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Principal Investigator: Wallis Marsh, MD WVU
More Information
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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: October 30, 2018
Last Verified: December 2017
Keywords provided by Madaus Inc:
amatoxin
amanita
mushroom poisoning
hepatic failure
 milk thistle
Silibinin
Legalon
Additional relevant MeSH terms:
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Liver Failure
Hepatic Insufficiency
Poisoning
Mushroom Poisoning
Liver Diseases
Digestive System Diseases
Chemically-Induced Disorders
Foodborne Diseases
Mycotoxicosis
 Silybin
Silymarin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Antineoplastic Agents