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

NCT00915681 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 148

Last updated 2022-04-07

Study results available
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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.

Conditions

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

Interventions

DRUG

Silibinin

20 mg/kg continuous IV is over 24 hours

Sponsors & Collaborators

  • Mylan Specialty, LP

    lead INDUSTRY

Principal Investigators

  • Wallis Marsh, MD · WVU

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-10
Primary Completion
2020-04-10
Completion
2020-04-10
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00915681 on ClinicalTrials.gov