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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: Clinical Trial Phase 2 study, sponsored by Mylan Specialty.
NCT00915681 is a Phase 2 study that was terminated before completion, run by Mylan Specialty. The registered enrollment target is 148 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (11% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Study was terminated, no analysis performed as data are unavailable for most patients
Interventions
- DRUG Silibinin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 148 participants |
| Start Date | 2009-11-10 |
| Est. Completion | 2020-04-10 |
| Phase | Phase 2 |
Why NCT00915681 stopped before completion
NCT00915681 is an interventional study that assigns participants to a tested intervention. The registered 148 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (11% higher).
The record links to 0 conditions, and to 1 intervention - of which Silibinin is the first listed.
NCT00915681 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00915681's enrollment target sits among peer trials
148 491st of 2000 higher than 1,506 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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