Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Intravenous Milk Thistle (Silibinin-Legalon) for Hepatic Failure Induced by Amatoxin/Amanita Mushroom Poisoning

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00915681
Recruitment Status : Terminated (Sponsor decision)
First Posted : June 8, 2009
Last Update Posted : July 7, 2020
Sponsor:
Collaborator:
Mylan Specialty Inc.
Information provided by (Responsible Party):
Mylan Inc.

Tracking Information
First Submitted Date  ICMJE June 4, 2009
First Posted Date  ICMJE June 8, 2009
Last Update Posted Date July 7, 2020
Study Start Date  ICMJE February 2010
Actual Primary Completion Date September 18, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 1, 2020)
The primary endpoint is the percentage of subjects treated under this clinical trial without morbidity (liver transplantation) and or mortality (death). [ Time Frame: 1 month ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 5, 2009)
prevention of severe morbidity (liver transplantation) and death [ Time Frame: 1 month ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: June 5, 2009)
  • 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 ]
  • cutaneous reactions [ Time Frame: 1 month ]
  • sodium [ Time Frame: 1 month ]
  • hemoglobin [ Time Frame: 1 month ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intravenous Milk Thistle (Silibinin-Legalon) for Hepatic Failure Induced by Amatoxin/Amanita Mushroom Poisoning
Official Title  ICMJE 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
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.
Detailed Description Patients with suspected amatoxin poisoning are reviewed for enrollment in the study by contacting the Legalon SIL study hotline (866) 520-4412.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Amatoxin Poisoning
  • Amanita Poisoning
  • Mushroom Poisoning
  • Liver Failure
Intervention  ICMJE Drug: Silibinin
20 mg/kg/day IV
Other Name: Legalon SIL
Study Arms  ICMJE Experimental: Legalon SIL
Silibinin: loading dose of one hour infusion of 5 mg/kg, followed by 20 mg/kg/day infused continuously via pump
Intervention: Drug: Silibinin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: July 1, 2020)
104
Original Estimated Enrollment  ICMJE
 (submitted: June 5, 2009)
400
Actual Study Completion Date  ICMJE September 18, 2019
Actual Primary Completion Date September 18, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. 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
  2. History of eating foraged mushrooms
  3. Gastrointestinal symptoms suggestive of amatoxin poisoning (cramping abdominal pain, nausea, vomiting, and / or watery diarrhea) usually 24-48 hours after of mushroom ingestion
  4. 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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00915681
Other Study ID Numbers  ICMJE SB16A1.07
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mylan Inc.
Study Sponsor  ICMJE Mylan Inc.
Collaborators  ICMJE Mylan Specialty Inc.
Investigators  ICMJE
Principal Investigator: Wallis Marsh, MD WVU
PRS Account Mylan Inc.
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP