Intravenous Silibinin for Amatoxin Induced Hepatic Failure - Full Text View

Sponsored by:	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 20-50 mg/kg/day via continuous infusion (13). 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 (Mushroom) Poisoning	Drug: Legalon SIL (Silibinin)	Phase II Phase III

Study Type:	Interventional
Study Design:	Treatment, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
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:	400
Study Start Date:	July 2009
Estimated Study Completion Date:	July 2020
Estimated Primary Completion Date:	July 2019 (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

Locations

United States, California
Dominican Santa Cruz Hospital
Santa Cruz, California, United States, 95065

Sponsors and Collaborators

Madaus Inc

Investigators

Principal Investigator:

Todd Mitchell, MD

Dominican Santa Cruz Hospital

More Information

No publications provided

Responsible Party:	Madaus INC ( J Veilleux, President )
Study ID Numbers:	SB16A1.07
Study First Received:	June 4, 2009
Last Updated:	June 5, 2009
ClinicalTrials.gov Identifier:	NCT00915681 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Madaus Inc:

amatoxin
mushroom
Silibinin

Study placed in the following topic categories:

Liver Failure
Liver Diseases
Antioxidants
Digestive System Diseases
Poisoning

Silymarin
Disorders of Environmental Origin
Silybin
Hepatic Insufficiency

Additional relevant MeSH terms:

Liver Failure
Liver Diseases
Antioxidants
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Poisoning
Disorders of Environmental Origin

Protective Agents
Silybin
Pharmacologic Actions
Digestive System Diseases
Silymarin
Hepatic Insufficiency

ClinicalTrials.gov processed this record on September 03, 2009