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

Mylan

Status and phase: Terminated; Phase 2

Conditions: Mushroom Poisoning; Liver Failure; Amatoxin Poisoning; Amanita Poisoning

Treatments: Drug: Silibinin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00915681

SB16A1.07

Details and patient eligibility

About

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.

Full description

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

Enrollment: 148 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Signed Informed Consent(s) for clinical trial participation (due to the potential critical status of the subject upon presentation, consent may need to be obtained from Legally Authorized Representative (LAR) per sites consenting policy and ICH/GCP guidance) Signed Informed Consent for Clinical Trial participation
2. History of eating foraged mushrooms
3. Gastrointestinal symptoms suggestive of amatoxin poisoning (cramping abdominal pain, nausea, vomiting, and / or watery diarrhea) usually 24-48 hours after of mushroom ingestion
4. Liver function tests suggestive of amatoxin poisoning: AST or ALT above the institutions upper limit of normal after mushroom ingestion

Exclusion criteria

1. Evidence of significant medical illness or any other abnormal laboratory finding that, in the Investigator's judgment, will substantially increase the risk associated with the subject's participation in, and completion of the study or could preclude the evaluation of the subject's response.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

148 participants in 1 patient group

Legalon SIL

Experimental group

Description:

Silibinin: loading dose of one hour infusion of 5 mg/kg, followed by 20 mg/kg/day infused continuously via pump

Treatment:

Drug: Silibinin