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 March 2016 by Madaus Inc
Sponsor:
Information provided by (Responsible Party):
Madaus Inc
ClinicalTrials.gov Identifier:
NCT00915681
First received: June 4, 2009
Last updated: March 18, 2016
Last verified: March 2016
  Purpose
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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: February 2010
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: September 2016 (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.
  Eligibility

Ages Eligible for Study:   2 Years and older   (Child, Adult, Senior)
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: NCT00915681

Contacts
Contact: Todd Mitchell, MD 831-479-7916 tmitchmd@yahoo.com
Contact: Michael J Purzycki, MS 732 564 2387 michael.purzycki@meda.us

Locations
United States, California
Dominican Santa Cruz Hospital Recruiting
Santa Cruz, California, United States, 95065
Contact: Todd Mitchell, MD    831-479-7916    tmitchMD@yahoo.com   
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
Investigators
Principal Investigator: Todd Mitchell, MD Dominican Santa Cruz Hospital
  More Information

Responsible Party: Madaus Inc
ClinicalTrials.gov Identifier: NCT00915681     History of Changes
Other Study ID Numbers: SB16A1.07 
Study First Received: June 4, 2009
Last Updated: March 18, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Madaus Inc:
amatoxin
amanita
mushroom poisoning
hepatic failure
milk thistle
Silibinin
Legalon

Additional relevant MeSH terms:
Foodborne Diseases
Liver Failure
Poisoning
Mushroom Poisoning
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Chemically-Induced Disorders
Mycotoxicosis
Silybin
Silymarin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 27, 2016