NCT00915681 is a Phase 2 clinical trial of Silibinin in Amatoxin Poisoning, sponsored by Mylan Specialty, LP.

Who is sponsoring NCT00915681?

NCT00915681 is sponsored by Mylan Specialty, LP.

What drugs are being tested in NCT00915681?

Interventions in NCT00915681: Silibinin.

What condition does NCT00915681 study?

NCT00915681 studies Amatoxin Poisoning, Amanita Poisoning, Mushroom Poisoning, Liver Failure.

Is NCT00915681 still recruiting?

NCT00915681 is currently terminated. Last updated 7 April 2022.

Are results published for NCT00915681?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2022-04-07 · How we verify

NCT00915681

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Terminated Phase 2 Results posted Last updated 7 April 2022

What this trial tests

Phase 2 trial testing Silibinin in Amatoxin Poisoning in 148 participants. Terminated before completion.

Timeline

10 November 2009

Primary endpoint
10 April 2020

10 April 2020

Quick facts

Lead sponsor	Mylan Specialty, LP
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	148
Start date	10 November 2009
Primary completion	10 April 2020
Estimated completion	10 April 2020
Sites	2 locations across United States

Drugs / interventions tested

Silibinin — full drug profile →

Conditions studied

Amatoxin Poisoning — all drugs for Amatoxin Poisoning →
Amanita Poisoning — all drugs for Amanita Poisoning →
Mushroom Poisoning — all drugs for Mushroom Poisoning →
Liver Failure — all drugs for Liver Failure →

Sponsor

Mylan Specialty, LP

Who can join

Eligibility, any sex, with Amatoxin Poisoning or Amanita Poisoning. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

Hepatoprotective and antiviral functions of silymarin components in hepatitis C virus infection.
Polyak SJ, Ferenci P, Pawlotsky JM. · · 2013 · cited 78× · PMID 23213025 · DOI 10.1002/hep.26179
Mycetism: a review of the recent literature.
Graeme KA. · · 2014 · cited 39× · PMID 24573533 · DOI 10.1007/s13181-013-0355-2
Amanita phalloides Mushroom Poisonings - Northern California, December 2016.
Vo KT, Montgomery ME, Mitchell ST, Scheerlinck PH, et al · · 2017 · cited 21× · PMID 28570504 · DOI 10.15585/mmwr.mm6621a1
Milk thistle: early seeds of potential.
Siegel AB, Stebbing J. · · 2013 · cited 18× · PMID 23993379 · DOI 10.1016/s1470-2045(13)70414-5
Novel Strategies Enhancing Bioavailability and Therapeutical Potential of Silibinin for Treatment of Liver Disorders.
Selc M, Macova R, Babelova A. · · 2024 · cited 11× · PMID 39444787 · DOI 10.2147/dddt.s483140
Mycetismus: a review.
Smith MR, Davis RL. · · 2016 · cited 10× · PMID 26637206 · DOI 10.1093/gastro/gov062

Verify or expand the search:

Other trials of Silibinin

Trials testing the same drug.

NCT05689619 — SILibinin in NSCLC and BC Patients With Single Brain METastasis (SILMET) · NA · recruiting
NCT05793489 — Prospective Double Arm Randomized Trial: WBRT Alone and WBRT Plus Silibinin · NA · active not recruiting
NCT03687073 — Trial of Indole-3-Carbinol and Silibinin · Phase 1 · completed

Other Mylan Specialty, LP trials

Trials by the same sponsor.

NCT05317312 — Study of MR-107A-02 in the Treatment of Post Surgical Dental Pain. · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00915681 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Mylan Specialty, LP
Last refreshed: 7 April 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00915681.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing