NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JMACCT ID: JMA-IIA00096

Registered date:17/08/2012

multicenter lymphangioleiomyomatosis sirolimus trial for safety

Basic Information

Recruitment status Completed
Health condition(s) or Problem(s) studiedlymphangioleiomyomatosis
Date of first enrollment05/09/2012
Target sample size65
Countries of recruitmentJapan
Study typeINTERVENTIONAL
Intervention(s)Intervention type:DRUG. Intervention1:Srolimus, Dose form:TABLET, Route of administration:ORAL, intended dose regimen:LAM patients will be medicated with 2mg of sirolimus every day for 2 years and modified dosage between 1mg and 3mg QD depend on the plasma concentration monitoring..

Outcome(s)

Primary OutcomeAll adverse events. Timepoint:6, 12, 18 and 24 month after the start of trial.
Secondary Outcome1) QOL tests 2) change of pulmonary function test (FEV1, FVC) 3) serum VEGF-D concentration 4) pharmacokinetics of sirolimus in 10 patients and sequential trough concentration of sirolimus in all patients 5) change of bone mineral dencity 6) change of plasma estrogen, progesterone and testosterone 7) comparison of trough concentration between 1mg and 2mg administration in same patients. Timepoint: before the treatment, every 3 month after the start of trial.

Key inclusion & exclusion criteria

Age minimum>=18 YEARS
Age maximumNo Limit
GenderFemale
Include criteriaa. written informed consent b. diagnosis of LAM by chest HRCT etc.
Exclude criteriaa. history of myocardial infarction, angina or stroke b. pregnant, breastfeeding or plans to become pregnant c. unable or unwilling to use adequate contraception d. significant hematologic or hepatic abnormality e. intercurrent infection or HBV career f. any surgery within 8 weeks of initiation of study drug g. uncontrolled hyperlipidemia h. previous lung transplant or currently on lung transplant list etc.

Related Information

Contact

public contact
Name Shigeru Imai
Address MLSTS Clinical Trial Office,Bioscience Medical Research Center, Niigata University Medical&Dental Hospital, 1-754 Asahimachi Dori, Chuoku, Niigata City Niigata 951-8520
Telephone +81-25-227-2029
E-mail mlsts@sogo-rinsho.jp
Affiliation Sogo Rinsho Medefi Co. Ltd.
scientific contact
Name Toshinori Takada
Address Secend Department of Medicine,1-754 Asahimachi Dori, Chuoku, Niigata City Niigata 951-8520 Japan
Telephone +81-70-6568-6378
E-mail
Affiliation Niita University Medical and Dental Hospital