Intravenous Milk Thistle (Silibinin-Legalon) for Hepatic Failure Induced by Amatoxin/Amanita Mushroom Poisoning
This study is currently recruiting participants.
Verified April 2017 by Madaus Inc
Sponsor:
Madaus Inc
ClinicalTrials.gov Identifier:
NCT00915681
First Posted: June 8, 2009
Last Update Posted: April 5, 2017
Collaborator:
Mylan Inc.
Information provided by (Responsible Party):
Madaus Inc
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Purpose
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 | Intervention | Phase |
|---|---|---|
| Amatoxin Poisoning Amanita Poisoning Mushroom Poisoning Liver Failure | Drug: Silibinin | Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | 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 |
Resource links provided by NLM:
Further study details as provided by Madaus Inc:
Primary Outcome Measures:
- percentage of patients survived without liver transplantation [ Time Frame: 1 month ]
| Estimated Enrollment: | 50 |
| Study Start Date: | February 2010 |
| Estimated Study Completion Date: | December 31, 2018 |
| Estimated Primary Completion Date: | December 31, 2018 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| 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
Contacts and Locations
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: Todd Mitchell, MD | 831-479-7916 | tmitchmd@yahoo.com | |
| Contact: Gail L Tribble, BSN | 412-651-9530 | gail.tribble@mylan.com |
Locations
| United States, California | |
| Dominican Santa Cruz Hospital | Recruiting |
| Santa Cruz, California, United States, 95065 | |
| Contact: Todd Mitchell, MD 831-479-7916 tmitchMD@yahoo.com | |
| Principal Investigator: Todd Mitchell, MD | |
| United States, New Jersey | |
| Recruitment Hot Line for the United States | Recruiting |
| Somerset, New Jersey, United States, 08873 | |
| Contact: Todd Mitchell, MD 866-520-4412 | |
Sponsors and Collaborators
Madaus Inc
Mylan Inc.
Investigators
| Principal Investigator: | Todd Mitchell, MD | Dominican Santa Cruz Hospital |
More Information
| Responsible Party: | Madaus Inc |
| ClinicalTrials.gov Identifier: | NCT00915681 History of Changes |
| Other Study ID Numbers: |
SB16A1.07 |
| First Submitted: | June 4, 2009 |
| First Posted: | June 8, 2009 |
| Last Update Posted: | April 5, 2017 |
| Last Verified: | April 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 |