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

NCT00915681 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: SB16A1.07
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

amatoxin; amanita; mushroom poisoning; hepatic failure; milk thistle; Silibinin; Legalon

Outcome Measures

Primary Outcomes (1)

• The Primary Endpoint is the Percentage of Subjects Treated Under This Clinical Trial Without Morbidity (Liver Transplantation) and or Mortality (Death).

  Study was terminated, no analysis performed as data are unavailable for most patients

  not applicable as no analysis was performed

Study Arms (1)

Legalon SIL

EXPERIMENTAL

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

Drug: Silibinin

Interventions

Silibinin DRUG

20 mg/kg continuous IV is over 24 hours

Also known as: Legalon SIL

Legalon SIL

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• History of eating foraged mushrooms
• Gastrointestinal symptoms suggestive of amatoxin poisoning (cramping abdominal pain, nausea, vomiting, and / or watery diarrhea) usually 24-48 hours after of mushroom ingestion
• Liver function tests suggestive of amatoxin poisoning: AST or ALT above the institutions upper limit of normal after mushroom ingestion

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Mylan Specialty, LP: lead

Study Sites (2)

Recruitment Hot Line for the United States

Somerset, New Jersey, 08873, United States

Location

Mylan Specialty LLP

Morgantown, West Virginia, 26504-4310, United States

Location

MeSH Terms

Conditions

Mushroom Poisoning; Liver Failure

Interventions

Silybin

Condition Hierarchy (Ancestors)

Foodborne Diseases; Poisoning; Chemically-Induced Disorders; Mycotoxicosis; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Silymarin; Flavonolignans; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Baerbel Fingerhut
• Organization: Meda Pharma GmbH & Co KG (A Viatris company)

baerbel.fingerhut@viatris.com

+49 6172 888

Study Officials

• Wallis Marsh, MD

  WVU

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2009
• First Posted: June 8, 2009
• Study Start: November 10, 2009
• Primary Completion: April 10, 2020
• Study Completion: April 10, 2020
• Last Updated: April 7, 2022
• Results First Posted: April 7, 2022

Record last verified: 2022-01

Locations

US (2)