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NCT00915681 · ClinicalTrials.gov registry record · Phase 2
Intravenous Milk Thistle (Silibinin-Legalon) for Hepatic Failure Induced by Amatoxin/Amanita Mushroom Poisoning
A Phase 2 study, sponsored by Mylan Specialty.
- Terminated
- Registry status
- Phase 2
- Development phase
- 148
- Enrollment target
NCT00915681 is a Phase 2 study that was terminated before completion, run by Mylan Specialty. The registered enrollment target is 148 participants.
The verdict
NCT00915681, a Phase 2 study, was terminated before completion, sponsored by Mylan Specialty.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 148 participants
- Enrollment target
Study 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.
Interventions
- DRUG Silibinin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 148 participants |
| Start Date | 2009-11-10 |
| Est. Completion | 2020-04-10 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00915681
The ClinicalTrials.gov registry entry for NCT00915681 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 148 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mylan Specialty, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Silibinin is the first listed.
NCT00915681 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00915681 about?
NCT00915681 is a clinical study titled "Intravenous Milk Thistle (Silibinin-Legalon) for Hepatic Failure Induced by Amatoxin/Amanita Mushroom Poisoning". 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 consi...
What is the current status of trial NCT00915681?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 148 participants. The study started on 2009-11-10. Estimated completion is 2020-04-10.
What interventions are being tested in trial NCT00915681?
The interventions under investigation include: Silibinin (DRUG).
Who is sponsoring clinical trial NCT00915681?
This trial is sponsored by Mylan Specialty, which has 2 total clinical trials registered on ClinicalTrials.gov.
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