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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	JPRN
Last refreshed on:	17 October 2023
Main ID:	JPRN-UMIN000016677
Date of registration:	02/03/2015
Prospective Registration:	No
Primary sponsor:	National Hospital Organization Kinki-chuo Chest Medical Center
Public title:	Efficacy and safety of low dose sirolimus in lymphangioleiomyomatosis
Scientific title:	Efficacy and safety of low dose sirolimus in lymphangioleiomyomatosis - Low dose sirolimus study
Date of first enrolment:	2015/01/01
Target sample size:	20
Recruitment status:	Recruiting
URL:	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019250
Study type:	Interventional
Study design:	Single arm Non-randomized
Phase:	Not selected

Countries of recruitment
Japan

Contacts

Name:	Chikatoshi Sugimoto
Address:	1180, Nagasone-cho Kita-ku, Sakai-city, Osaka, 591-8555, Japan Japan
Telephone:	072-252-3021
Email:	sugimoto@kch.hosp.go.jp
Affiliation:	National Hospital Organization Kinki-Chuo Chest Medical Center Clinical Research Center

Name:	Yoshikazu Inoue
Address:	1180, Nagasone-cho Kita-ku, Sakai-city, Osaka, 591-8555, Japan Japan
Telephone:	072-252-3021
Email:	giichi@kch.hosp.go.jp
Affiliation:	National Hospital Organization Kinki-Chuo Chest Medical Center Clinical Research Center

Key inclusion & exclusion criteria

Inclusion criteria:
Exclusion criteria: 1) Pregnancy or planning of pregnancy or lactating 2) Severe dysemia or impairment of liver function 3) Active infection 4) Operation within 8 weeks 5) Severe dyslipidemia 6) Active registration of lung transplantation 7) Allergy of sirolimus

Age minimum: Not applicable
Age maximum: Not applicable
Gender: Male and Female

Health Condition(s) or Problem(s) studied

lymphangioleiomyomatosis

Intervention(s)

sirolimus 1mg/day / sirolimus 2mg/day

Primary Outcome(s)

1) The FEV1 response, which is assessed as the rate of change in FEV1 or the SGRQ score response. 2) Adverse events in sirolimus 1mg/day and 2mg/day.

Secondary Outcome(s)

Secondary ID(s)

Source(s) of Monetary Support

National Hospital Organization Kinki-chuo Chest Medical Center

Secondary Sponsor(s)

Ethics review

Status: YES
Approval date:
Contact:

Results

Results available:
Date Posted:
Date Completed:
URL:

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