The pharmacokinetic analysis and safety of sirolimus treatment for pediatric patients with intractable vascular anomalies

The pharmacokinetic analysis and safety of sirolimus treatment for pediatric patients with intractable vascular anomalies - The pharmacokinetic analysis of sirolimus for pediatric patients with intractable vascular anomalies

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000029175

Enrollment

Registered

2017-09-17

Start date

2017-09-17

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intractable vascular anomalies

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The patients with intractable vascular anomalies who are going to treat with sirolimus

Exclusion criteria

Exclusion criteria: 1. Patients with a history of hypersensitivity to ingredients of this drug 2. Patients with serious liver and renal disorders 3. Patients with symptoms that affect cytokine value of such obvious infection at the time of specimen collection 4. Patients must also avoid strong inducers of CYP3A4 5. Past usage of mTOR inhibitors or other molecular target drugs relating mTOR pathway 6. Patient who is judged inappropriate to participate in this study by the investigators

Design outcomes

Primary

Measure	Time frame
The pharmacokinetic analysis of sirolimus treatment for the Japanese pediatric patients	—

Secondary

Measure	Time frame
The safety of sirolimus treatment for the Japanese pediatric patients The association between the trough levels of sirolimus and adverse effects	—

Countries

Japan

Contacts

Public ContactMichio Ozeki

Gifu University Hospital The department of Pediatrics

michioo@gifu-u.ac.jp058-230-6000

Outcome results