Back to resultsIntravenous Milk Thistle (Silibinin-Legalon) for Hepatic Failure Induced by Amatoxin/Amanita Mushroom Poisoning
Primary Purpose
Amatoxin Poisoning, Amanita Poisoning, Mushroom Poisoning
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Silibinin
Sponsored by
About this trial
This is an interventional treatment trial for Amatoxin Poisoning focused on measuring amatoxin, amanita, mushroom poisoning, hepatic failure, milk thistle, Silibinin, Legalon
Eligibility Criteria
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.
Sites / Locations
- Recruitment Hot Line for the United States
- Mylan Specialty LLP
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Legalon SIL
Arm Description
Silibinin: loading dose of one hour infusion of 5 mg/kg, followed by 20 mg/kg/day infused continuously via pump
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00915681
Brief Title
Intravenous Milk Thistle (Silibinin-Legalon) for Hepatic Failure Induced by Amatoxin/Amanita Mushroom Poisoning
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Terminated
Why Stopped
Sponsor decision
Study Start Date
November 10, 2009 (Actual)
Primary Completion Date
April 10, 2020 (Actual)
Study Completion Date
April 10, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mylan Specialty, LP
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Patients with suspected amatoxin poisoning are reviewed for enrollment in the study by contacting the Legalon SIL study hotline (866) 520-4412.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amatoxin Poisoning, Amanita Poisoning, Mushroom Poisoning, Liver Failure
Keywords
amatoxin, amanita, mushroom poisoning, hepatic failure, milk thistle, Silibinin, Legalon
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
148 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Legalon SIL
Arm Type
Experimental
Arm Description
Silibinin: loading dose of one hour infusion of 5 mg/kg, followed by 20 mg/kg/day infused continuously via pump
Intervention Type
Drug
Intervention Name(s)
Silibinin
Other Intervention Name(s)
Legalon SIL
Intervention Description
20 mg/kg continuous IV is over 24 hours
Primary Outcome Measure Information:
Title
The Primary Endpoint is the Percentage of Subjects Treated Under This Clinical Trial Without Morbidity (Liver Transplantation) and or Mortality (Death).
Description
Study was terminated, no analysis performed as data are unavailable for most patients
Time Frame
not applicable as no analysis was performed
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wallis Marsh, MD
Organizational Affiliation
WVU
Official's Role
Principal Investigator
Facility Information:
Facility Name
Recruitment Hot Line for the United States
City
Somerset
State/Province
New Jersey
ZIP/Postal Code
08873
Country
United States
Facility Name
Mylan Specialty LLP
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26504-4310
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Intravenous Milk Thistle (Silibinin-Legalon) for Hepatic Failure Induced by Amatoxin/Amanita Mushroom Poisoning
We'll reach out to this number within 24 hrs