Intravenous Milk Thistle (Silibinin-Legalon) for Hepatic Failure Induced by Amatoxin/Amanita Mushroom Poisoning
This study is currently recruiting participants.
Verified June 2011 by Madaus Inc
Sponsor:
Madaus Inc
Information provided by (Responsible Party):
Madaus Inc
ClinicalTrials.gov Identifier:
NCT00915681
First received: June 4, 2009
Last updated: October 26, 2012
Last verified: June 2011
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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: Legalon SIL (Silibinin) |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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:
- prevention of severe morbidity (liver transplantation) and death [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Improvement in presenting abnormalities as evaluated by time to normality for hepatic and renal function tests (AST, ALT, bilirubin, PT/INR, creatinine). [ Time Frame: 1 month ] [ Designated as safety issue: No ]
- cutaneous reactions [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
- sodium [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
- hemoglobin [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 50 |
| Study Start Date: | February 2010 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Legalon SIL
Legalon SIL
|
Drug: Legalon SIL (Silibinin)
20 mg/kg/day IV
|
Eligibility| Ages Eligible for Study: | 2 Years and older |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00915681
Contacts
| Contact: Todd Mitchell, MD | 831-479-7916 | tmitchmd@yahoo.com |
| Contact: Joe Veilleux | 412-279-8808 | joev@euromedusa.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 | |
| Contact: Alan Buchwald, MD 831-761-0260 albuchwald955@pol.net | |
| Principal Investigator: Todd Mitchell, MD | |
| United States, Pennsylvania | |
| Recruitment Hot Line for the United States | Recruiting |
| Pittsburg, Pennsylvania, United States | |
| Contact: Todd Mitchell, MD 866-520-4412 | |
| Contact: Alan buchwald, MD 866-520-4412 | |
| Principal Investigator: Todd Michell, MD | |
| Sub-Investigator: Alan Buchwald, MD | |
Sponsors and Collaborators
Madaus Inc
Investigators
| Principal Investigator: | Todd Mitchell, MD | Dominican Santa Cruz Hospital |
More Information
No publications provided
| Responsible Party: | Madaus Inc |
| ClinicalTrials.gov Identifier: | NCT00915681 History of Changes |
| Other Study ID Numbers: | SB16A1.07 |
| Study First Received: | June 4, 2009 |
| Last Updated: | October 26, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Madaus Inc:
|
amatoxin amanita mushroom poisoning hepatic failure |
milk thistle Silibinin Legalon |
Additional relevant MeSH terms:
|
Silymarin Mushroom Poisoning Poisoning Liver Failure Foodborne Diseases Substance-Related Disorders Mycotoxicosis Hepatic Insufficiency |
Liver Diseases Digestive System Diseases Silybin Antioxidants Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protective Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 23, 2013