Overview

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

Status:
Terminated
Trial end date:
2019-09-18
Target enrollment:
Participant gender:
Summary
LegalonĀ® 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. LegalonĀ® 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 LegalonĀ® SIL therapy with follow up lab studies.
Phase:
Phase 2
Details
Lead Sponsor:
Madaus Inc
Mylan Inc.
Collaborator:
Mylan Specialty Inc.
Treatments:
Silybin
Silymarin