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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Madaus Inc.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Madaus Inc
ClinicalTrials.gov Identifier:
NCT00915681
First received: June 4, 2009
Last updated: October 26, 2012
Last verified: June 2011
  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: Legalon SIL (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:
  • prevention of severe morbidity (liver transplantation) and death [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement in presenting abnormalities as evaluated by time to normality for hepatic and renal function tests (AST, ALT, bilirubin, PT/INR, creatinine). [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • cutaneous reactions [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • sodium [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • hemoglobin [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: February 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Legalon SIL
Legalon SIL
Drug: Legalon SIL (Silibinin)
20 mg/kg/day IV

  Eligibility

Ages Eligible for Study:   2 Years and older
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: Joe Veilleux 412-279-8808 joev@euromedusa.com

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   
Contact: Alan Buchwald, MD    831-761-0260    albuchwald955@pol.net   
Principal Investigator: Todd Mitchell, MD         
United States, Pennsylvania
Recruitment Hot Line for the United States Recruiting
Pittsburg, Pennsylvania, United States
Contact: Todd Mitchell, MD    866-520-4412      
Contact: Alan buchwald, MD    866-520-4412      
Principal Investigator: Todd Michell, MD         
Sub-Investigator: Alan Buchwald, MD         
Sponsors and Collaborators
Madaus Inc
Investigators
Principal Investigator: Todd Mitchell, MD Dominican Santa Cruz Hospital
  More Information

No publications provided

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: October 26, 2012
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:
Mushroom Poisoning
Poisoning
Liver Failure
Foodborne Diseases
Chemically-Induced Disorders
Mycotoxicosis
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Silymarin
Silybin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 11, 2014