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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.
 
ClinicalTrials.gov Identifier: NCT00915681
Recruitment Status : Terminated (Sponsor decision)
First Posted : June 8, 2009
Results First Posted : April 7, 2022
Last Update Posted : April 7, 2022
Sponsor:
Information provided by (Responsible Party):
Viatris Inc. ( Mylan Specialty, LP )

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

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)
Actual Enrollment : 148 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Multi-Center Open-Label Clinical Trial to Assess the Prevention of Liver Transplantation and/or Death Among Subjects Treated With Intravenous Silibinin (Legalon® SIL) for Amatoxin Induced Hepatic Failure
Actual Study Start Date : November 10, 2009
Actual Primary Completion Date : April 10, 2020
Actual Study Completion Date : April 10, 2020

Resource links provided by the National Library of Medicine

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 continuous IV is over 24 hours
Other Name: Legalon SIL


Outcome Measures
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Primary Outcome Measures :
  1. The Primary Endpoint is the Percentage of Subjects Treated Under This Clinical Trial Without Morbidity (Liver Transplantation) and or Mortality (Death). [ Time Frame: not applicable as no analysis was performed ]
    Study was terminated, no analysis performed as data are unavailable for most patients


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Signed Informed Consent(s) for clinical trial participation (due to the potential critical status of the subject upon presentation, consent may need to be obtained from Legally Authorized Representative (LAR) per sites consenting policy and ICH/GCP guidance) Signed Informed Consent for Clinical Trial participation
  2. History of eating foraged mushrooms
  3. Gastrointestinal symptoms suggestive of amatoxin poisoning (cramping abdominal pain, nausea, vomiting, and / or watery diarrhea) usually 24-48 hours after of mushroom ingestion
  4. Liver function tests suggestive of amatoxin poisoning: AST or ALT above the institutions upper limit of normal after mushroom ingestion

Exclusion criteria:

1. Evidence of significant medical illness or any other abnormal laboratory finding that, in the Investigator's judgment, will substantially increase the risk associated with the subject's participation in, and completion of the study or could preclude the evaluation of the subject's response.

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


Locations
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United States, New Jersey
Recruitment Hot Line for the United States
Somerset, New Jersey, United States, 08873
United States, West Virginia
Mylan Specialty LLP
Morgantown, West Virginia, United States, 26504-4310
Sponsors and Collaborators
Mylan Specialty, LP
Investigators
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Principal Investigator: Wallis Marsh, MD WVU
  Study Documents (Full-Text)

Documents provided by Viatris Inc. ( Mylan Specialty, LP ):
Study Protocol and Statistical Analysis Plan  [PDF] December 3, 2018

More Information
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Responsible Party: Mylan Specialty, LP
ClinicalTrials.gov Identifier: NCT00915681    
Other Study ID Numbers: SB16A1.07
First Posted: June 8, 2009    Key Record Dates
Results First Posted: April 7, 2022
Last Update Posted: April 7, 2022
Last Verified: January 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Viatris Inc. ( Mylan Specialty, LP ):
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
Protective Agents
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Antineoplastic Agents