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Sponsor decision
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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.
Patients with suspected amatoxin poisoning are reviewed for enrollment in the study by contacting the Legalon SIL study hotline (866) 520-4412.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Legalon SIL | Experimental | Silibinin: loading dose of one hour infusion of 5 mg/kg, followed by 20 mg/kg/day infused continuously via pump |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Silibinin | Drug | 20 mg/kg continuous IV is over 24 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Primary Endpoint is the Percentage of Subjects Treated Under This Clinical Trial Without Morbidity (Liver Transplantation) and or Mortality (Death). | Study was terminated, no analysis performed as data are unavailable for most patients | not applicable as no analysis was performed |
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Inclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Wallis Marsh, MD | WVU | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Recruitment Hot Line for the United States | Somerset | New Jersey | 08873 | United States | ||
| Mylan Specialty LLP |
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148 screened, 102 treated FPI: 10-Nov-2009, LPO: 10-Apr-2020
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| ID | Title | Description |
|---|---|---|
| FG000 | Legalon SIL | Silibinin: loading dose of one hour infusion of 5 mg/kg, followed by 20 mg/kg/day infused continuously via pump Silibinin: 20 mg/kg/day IV |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Study was terminated, no analysis performed as data are unavailable for most patients.
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| ID | Title | Description |
|---|---|---|
| BG000 | Legalon SIL | Silibinin: loading dose of one hour infusion of 5 mg/kg, followed by 20 mg/kg/day infused continuously via pump Silibinin: 20 mg/kg/day IV |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | data are unavailable for 31 patients out of the 102 treated patients |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Primary Endpoint is the Percentage of Subjects Treated Under This Clinical Trial Without Morbidity (Liver Transplantation) and or Mortality (Death). | Study was terminated, no analysis performed as data are unavailable for most patients | The data is determined to be unreliable and this has been communicated to FDA and the IRB/EC; Therefore the study data cannot be analyzed and summarized to be reported except for the basic information. | Posted | not applicable as no analysis was performed |
|
up to 10 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Legalon SIL | Silibinin: loading dose of one hour infusion of 5 mg/kg, followed by 20 mg/kg/day infused continuously via pump Silibinin: 20 mg/kg/day IV |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Baerbel Fingerhut | Meda Pharma GmbH & Co KG (A Viatris company) | +49 6172 888 | 1419 | baerbel.fingerhut@viatris.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 3, 2018 | Feb 16, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009145 | Mushroom Poisoning |
| D017093 | Liver Failure |
| ID | Term |
|---|---|
| D005517 | Foodborne Diseases |
| D011041 | Poisoning |
| D064419 | Chemically-Induced Disorders |
| D015651 | Mycotoxicosis |
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| ID | Term |
|---|---|
| D000077385 | Silybin |
| ID | Term |
|---|---|
| D012838 | Silymarin |
| D044947 | Flavonolignans |
| D005419 | Flavonoids |
| D002867 | Chromones |
| D001578 |
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| Morgantown |
| West Virginia |
| 26504-4310 |
| United States |
| Count of Participants |
| Participants |
|
| Age, Continuous | data are unavailable for 31 patients out of the 102 treated patients | Mean | Standard Deviation | years |
|
| Sex: Female, Male | data are unavailable for 31 patients out of the 102 treated patients | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | data are unavailable for 31 patients out of the 102 treated patients | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
| 0 |
| 102 |
| 0 |
| 102 |
| 0 |
| 102 |
Mylan is allowed to require modifications.
| D048550 |
| Hepatic Insufficiency |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |