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 September 2014 by Madaus Inc
Sponsor:
Information provided by (Responsible Party):
Madaus Inc
ClinicalTrials.gov Identifier:
NCT00915681
First received: June 4, 2009
Last updated: September 15, 2014
Last verified: September 2014

June 4, 2009
September 15, 2014
February 2010
June 2015   (final data collection date for primary outcome measure)
prevention of severe morbidity (liver transplantation) and death [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00915681 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Intravenous Milk Thistle (Silibinin-Legalon) for Hepatic Failure Induced by Amatoxin/Amanita Mushroom Poisoning
Prevention and Treatment of Amatoxin Induced Hepatic Failure With Intravenous Silibinin ( Legalon® SIL): An Open Multicenter Clinical Trial

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.

Not Provided
Interventional
Phase 2
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Amatoxin Poisoning
  • Amanita Poisoning
  • Mushroom Poisoning
  • Liver Failure
Drug: Legalon SIL (Silibinin)
20 mg/kg/day IV
Experimental: Legalon SIL
Legalon SIL
Intervention: Drug: Legalon SIL (Silibinin)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
December 2015
June 2015   (final data collection date for primary outcome measure)

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
Both
2 Years and older
No
Contact: Todd Mitchell, MD 831-479-7916 tmitchmd@yahoo.com
Contact: Joe Veilleux 412-279-8808 joev@euromedusa.com
United States
 
NCT00915681
SB16A1.07
No
Madaus Inc
Madaus Inc
Not Provided
Principal Investigator: Todd Mitchell, MD Dominican Santa Cruz Hospital
Madaus Inc
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP