Intravenous Milk Thistle (Silibinin-Legalon) for Hepatic Failure Induced by Amatoxin/Amanita Mushroom Poisoning
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ClinicalTrials.gov Identifier: NCT00915681 |
Recruitment Status :
Terminated
(Sponsor decision)
First Posted : June 8, 2009
Results First Posted : April 7, 2022
Last Update Posted : April 7, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Amatoxin Poisoning Amanita Poisoning Mushroom Poisoning Liver Failure | Drug: Silibinin | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 148 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | November 10, 2009 |
Actual Primary Completion Date : | April 10, 2020 |
Actual Study Completion Date : | April 10, 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: Legalon SIL
Silibinin: loading dose of one hour infusion of 5 mg/kg, followed by 20 mg/kg/day infused continuously via pump
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Drug: Silibinin
20 mg/kg continuous IV is over 24 hours
Other Name: Legalon SIL |
- The Primary Endpoint is the Percentage of Subjects Treated Under This Clinical Trial Without Morbidity (Liver Transplantation) and or Mortality (Death). [ Time Frame: not applicable as no analysis was performed ]Study was terminated, no analysis performed as data are unavailable for most patients

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00915681
United States, New Jersey | |
Recruitment Hot Line for the United States | |
Somerset, New Jersey, United States, 08873 | |
United States, West Virginia | |
Mylan Specialty LLP | |
Morgantown, West Virginia, United States, 26504-4310 |
Principal Investigator: | Wallis Marsh, MD | WVU |
Documents provided by Viatris Inc. ( Mylan Specialty, LP ):
Responsible Party: | Mylan Specialty, LP |
ClinicalTrials.gov Identifier: | NCT00915681 |
Other Study ID Numbers: |
SB16A1.07 |
First Posted: | June 8, 2009 Key Record Dates |
Results First Posted: | April 7, 2022 |
Last Update Posted: | April 7, 2022 |
Last Verified: | January 2022 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
amatoxin amanita mushroom poisoning hepatic failure |
milk thistle Silibinin Legalon |
Liver Failure Hepatic Insufficiency Poisoning Mushroom Poisoning Liver Diseases Digestive System Diseases Chemically-Induced Disorders |
Foodborne Diseases Mycotoxicosis Silybin Protective Agents Physiological Effects of Drugs Antineoplastic Agents, Phytogenic Antineoplastic Agents |