Lymphangioleiomyomatosis, Refractory Lymphatic Disorders
Conditions
Interventions
None listed
Sponsors
Niigata University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients and healthy adults who participated in past studies using Sirolimus (the following 4 trials): A multi-institutional clinical trial on the safety of Sirolimus administration for lymphangioleiomyomatosis (MLSTS Trial) / Niigata University Medical and Dental Hospital A multi-institutional, Phase III, investigator-initiated clinical trial to study the efficacy and safety of NPC-12T (Sirolimus) for refractory lymphatic disorders (NPC-12T-LM Trial) / Gifu University Hospital A multi-institutional, Phase III, investigator-initiated clinical trial to study the efficacy and safety of NPC-12T (granules/tablets) for refractory vascular tumors and vascular malformations (NPC-12T-CVA Trial) / Gifu University Hospital A multi-institutional, open-label, non-controlled trial to study the safety and efficacy of Sirolimus for refractory vascular and lymphatic disorders (SRL-ACV-01 Trial) / Gifu University Hospital
Exclusion criteria
Exclusion criteria: Declined to participate in the research
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| We will conduct a cross-sectional analysis and examination of the collected trial data in terms of safety (compiling adverse events) and pharmacokinetic information (PK parameters)." | — |
Countries
Japan
Contacts
Public ContactTakahiro Tanaka
Niigata University Medical and Dental Hospital Clinical and Translational Research Center
Outcome results
None listed