Intravenous Milk Thistle (Silibinin-Legalon) for Hepatic Failure Induced by Amatoxin/Amanita Mushroom Poisoning
| Status: | Recruiting |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 2 - Any |
| Updated: | 11/1/2018 |
| Start Date: | February 2010 |
| End Date: | December 31, 2018 |
| Contact: | Judy Sherry |
| Phone: | 866-520-4412 |
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.
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.
Patients with suspected amatoxin poisoning are reviewed for enrollment in the study by
contacting the Legalon SIL study hotline (866) 520-4412.
contacting the Legalon SIL study hotline (866) 520-4412.
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
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