Intravenous Milk Thistle (Silibinin-Legalon) for Hepatic Failure Induced by Amatoxin/Amanita Mushroom Poisoning
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ClinicalTrials.gov Identifier: NCT00915681 |
Recruitment Status
:
Recruiting
First Posted
: June 8, 2009
Last Update Posted
: December 26, 2017
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Amatoxin Poisoning Amanita Poisoning Mushroom Poisoning Liver Failure | Drug: Silibinin | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 50 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Prevention and Treatment of Amatoxin Induced Hepatic Failure With Intravenous Silibinin ( Legalon® SIL): An Open Multicenter Clinical Trial |
Study Start Date : | February 2010 |
Estimated Primary Completion Date : | December 31, 2018 |
Estimated Study Completion Date : | December 31, 2018 |

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
|
Drug: Silibinin
20 mg/kg/day IV
Other Name: Legalon SIL
|
- percentage of patients survived without liver transplantation [ Time Frame: 1 month ]

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Ages Eligible for Study: | 2 Years and older (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- History of eating foraged mushrooms
- Gastrointestinal symptoms suggestive of amatoxin poisoning (cramping abdominal pain, nausea, vomiting, and / or watery diarrhea) within 48 hrs of mushroom ingestion
- Liver function tests suggestive of amatoxin poisoning: AST or ALT above the upper limit of normal within 48 hrs after mushroom ingestion
- Gender: male or female
- Age: > 2 yr

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
Contact: Kathleen Baker, BSN | 304-288-4935 | ||
Contact: Wallis Marsh, MD | 412-522-4334 |
United States, New Jersey | |
Recruitment Hot Line for the United States | Recruiting |
Somerset, New Jersey, United States, 08873 | |
Contact: Kathleen Baker, BSN 866-520-4412 | |
United States, Pennsylvania | |
Mylan | Recruiting |
Canonsburg, Pennsylvania, United States, 15317 | |
Contact: Ketty Belizaire 908-566-8260 ketty.belizaire@mylan.com | |
Contact: Gail Tribble 412-651-9530 gail.tribble@mylan.com |
Principal Investigator: | Wallis Marsh, MD | WVU |
Responsible Party: | Madaus Inc |
ClinicalTrials.gov Identifier: | NCT00915681 History of Changes |
Other Study ID Numbers: |
SB16A1.07 |
First Posted: | June 8, 2009 Key Record Dates |
Last Update Posted: | December 26, 2017 |
Last Verified: | December 2017 |
Keywords provided by Madaus Inc:
amatoxin amanita mushroom poisoning hepatic failure |
milk thistle Silibinin Legalon |
Additional relevant MeSH terms:
Liver Failure Poisoning Mushroom Poisoning Hepatic Insufficiency Liver Diseases Digestive System Diseases Chemically-Induced Disorders Foodborne Diseases |
Mycotoxicosis Silymarin Silybin Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs |