Status:
TERMINATED
Intravenous Milk Thistle (Silibinin-Legalon) for Hepatic Failure Induced by Amatoxin/Amanita Mushroom Poisoning
Lead Sponsor:
Mylan Specialty, LP
Conditions:
Amatoxin Poisoning
Amanita Poisoning
Eligibility:
All Genders
Phase:
PHASE2
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). Pa...
Detailed Description
Patients with suspected amatoxin poisoning are reviewed for enrollment in the study by contacting the Legalon SIL study hotline (866) 520-4412.
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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
- 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.
Exclusion
Key Trial Info
Start Date :
November 10 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 10 2020
Estimated Enrollment :
148 Patients enrolled
Trial Details
Trial ID
NCT00915681
Start Date
November 10 2009
End Date
April 10 2020
Last Update
April 7 2022
Active Locations (2)
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1
Recruitment Hot Line for the United States
Somerset, New Jersey, United States, 08873
2
Mylan Specialty LLP
Morgantown, West Virginia, United States, 26504-4310