NCT00915681

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

A Phase II Multi-Center Open-Label Clinical Trial to Assess the Prevention of Liver Transplantation and/or Death Among Subjects Treated With Intravenous Silibinin (Legalon® SIL) for Amatoxin Induced Hepatic Failure

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 148 (actual)
• Sponsor: Mylan Specialty, LP · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Patients with suspected amatoxin poisoning are reviewed for enrollment in the study by contacting the Legalon SIL study hotline [phone].

Conditions

• Amatoxin Poisoning
• Amanita Poisoning
• Mushroom Poisoning
• Liver Failure

Interventions

Type	Name	Description
DRUG	Silibinin	20 mg/kg continuous IV is over 24 hours

Timeline

• Start date: 2009-11-10
• Primary completion: 2020-04-10
• Completion: 2020-04-10
• First posted: 2009-06-08
• Last updated: 2022-04-07
• Results posted: 2022-04-07

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study