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

Sponsor:	Madaus Inc
Information provided by:	Madaus Inc
ClinicalTrials.gov Identifier:	NCT00915681

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 II Phase III

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:

MedlinePlus related topics: Poisoning

Drug Information available for: silybin Silymarin

U.S. FDA Resources

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 2012
Estimated Primary Completion Date:	November 2011 (Final data collection date for primary outcome measure)

Intervention Details:

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

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:	J Veilleux, President, Madaus INC
ClinicalTrials.gov Identifier:	NCT00915681 History of Changes
Other Study ID Numbers:	SB16A1.07
Study First Received:	June 4, 2009
Last Updated:	June 13, 2011
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
Substance-Related 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 February 09, 2012