Intravenous Milk Thistle (Silibinin-Legalon) for Hepatic Failure Induced by Amatoxin/Amanita Mushroom Poisoning
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00915681 |
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Recruitment Status
:
Recruiting
First Posted
: June 8, 2009
Last Update Posted
: December 26, 2017
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Sponsor:
Madaus Inc
Collaborator:
Mylan Inc.
Information provided by (Responsible Party):
Madaus Inc
- Study Details
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- No Results Posted
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Amatoxin Poisoning Amanita Poisoning Mushroom Poisoning Liver Failure | Drug: Silibinin | Phase 2 Phase 3 |
Patients with suspected amatoxin poisoning are reviewed for enrollment in the study by contacting the Legalon SIL study hotline (866) 520-4412.
| 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 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Poisoning
Drug Information available for:
Silymarin
U.S. FDA Resources
| Arm | Intervention/treatment |
|---|---|
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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/day IV
Other Name: Legalon SIL
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Primary Outcome Measures
:
- percentage of patients survived without liver transplantation [ Time Frame: 1 month ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 2 Years and older (Child, Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Information from the National Library of Medicine
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
Contacts
| Contact: Kathleen Baker, BSN | 304-288-4935 | ||
| Contact: Wallis Marsh, MD | 412-522-4334 |
Locations
| 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 | |
Sponsors and Collaborators
Madaus Inc
Mylan Inc.
Investigators
| 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:
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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 |