NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JMACCT ID: JMA-IIA00037

Registered date:15/03/2010

MLLTS trial

Basic Information

Recruitment status Other
Health condition(s) or Problem(s) studiedlymphangioleiomyomatosis
Date of first enrollment01/10/2011
Target sample size50
Countries of recruitmentJapan
Study typeINTERVENTIONAL
Intervention(s)Intervention type:DRUG. Intervention1:sirolimus, Dose form:TABLET, Route of administration:ORAL, intended dose regimen:LAM patients will be medicated with 2mg of sirolimus every day for 2 years..

Outcome(s)

Primary OutcomeAll adverse events. Timepoint:before the trial, every 3 month after the start of trial.
Secondary Outcome1, adverse events 2, walk distance of 6MT 3, pulmonary function test 4, frequency of pneumothorax or amount of effusion of chylothorax. Timepoint: before the trial, every 3 month after the start of trial.

Key inclusion & exclusion criteria

Age minimum>=18 YEARS
Age maximumNo Limit
GenderFemale
Include criteria1. LAM patients with definitive diagnosis. 2. patients who is expected to live more than two years. 3. patients who can visit out patient clinic periodically. 4. patients from whom a written informed consent will be obtained.
Exclude criteria

Related Information

Contact

public contact
Name Ryushi Tazawa
Address Bioscience Medical Research Center,1-754 Asahimachi-Dori Chuoku, Niigata City
Telephone +81-25-227-2022
E-mail ryushi@med.niigata-u.ac.jp
Affiliation Niigata University Medical and Dental Hospital
scientific contact
Name Koh Nakata
Address Bioscience Medical Research Center,1-754 Asahimachi-Dori Chuoku, Niigata City
Telephone +81-25-227-0847
E-mail
Affiliation Niigata University Medical and Dental Hospital