Trial Outcomes & Findings for Intravenous Milk Thistle (Silibinin-Legalon) for Hepatic Failure Induced by Amatoxin/Amanita Mushroom Poisoning (NCT NCT00915681)

NCT ID: NCT00915681

Last Updated: 2022-04-07

Results Overview

Study was terminated, no analysis performed as data are unavailable for most patients

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

148 participants

Primary outcome timeframe

not applicable as no analysis was performed

Results posted on

2022-04-07

Participant Flow

148 screened, 102 treated FPI: 10-Nov-2009, LPO: 10-Apr-2020

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	148
Overall Study COMPLETED	102
Overall Study NOT COMPLETED	46

Reasons for withdrawal

Reasons for withdrawal
Measure	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
Overall Study Screening failures	46

Baseline Characteristics

data are unavailable for 31 patients out of the 102 treated patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Legalon SIL n=102 Participants 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
Age, Categorical <=18 years	4 Participants n=71 Participants • data are unavailable for 31 patients out of the 102 treated patients
Age, Categorical Between 18 and 65 years	41 Participants n=71 Participants • data are unavailable for 31 patients out of the 102 treated patients
Age, Categorical >=65 years	26 Participants n=71 Participants • data are unavailable for 31 patients out of the 102 treated patients
Age, Continuous	54.9 years STANDARD_DEVIATION 19.89 • n=71 Participants • data are unavailable for 31 patients out of the 102 treated patients
Sex: Female, Male Female	37 Participants n=71 Participants • data are unavailable for 31 patients out of the 102 treated patients
Sex: Female, Male Male	34 Participants n=71 Participants • data are unavailable for 31 patients out of the 102 treated patients
Region of Enrollment United States	71 participants n=71 Participants • data are unavailable for 31 patients out of the 102 treated patients

PRIMARY outcome

Timeframe: not applicable as no analysis was performed

Population: 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.

Study was terminated, no analysis performed as data are unavailable for most patients

Outcome measures

Outcome data not reported

Adverse Events

Legalon SIL

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Baerbel Fingerhut

Meda Pharma GmbH & Co KG (A Viatris company)

Phone: +49 6172 888

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Mylan is allowed to require modifications.
Publication restrictions are in place

Restriction type: OTHER