臨床研究等提出・公開システム

Japanese

Date of registration	Mar. 11, 2021
Last modified on	Mar. 11, 2021
Trial ID	jRCT1041200111

Scientific Title	Effect of balloon pulmonary angioplasty on the pharmacokinetics of riociguat (BPA: Balloon Pulmonary Angiotherapy)
Public Title	Pharmacokinetic changes in Riociguat before and after catheterization

Contact for Scientific Queries	Name	Tatsuguchi Mariko
	Affiliation	Hamamatsu University School of Medicine
	Address	1-20-1 Handayama Higashiku Hamamatsu City
	Telephone	+81-53-435-2385
	E-mail	marikot@hama-med.ac.jp
Contact for Public Queries	Name	Tatsuguchi Mariko
	Affiliation	Hamamatsu University School of Medicine
	Address	1-20-1 Handayama Higashiku Hamamatsu City
	Telephone	+81-53-435-2385
	E-mail	marikot@hama-med.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Mar. 11, 2021
Actual date of first enrollment
Target sample size		30
Study Type		Interventional
Study Design	allocation	non-randomized controlled trial
	masking	open(masking not used)
	control	active control
	assignment	single assignment
	purpose	other
Key inclusion & exclusion criteria	Inclusion Criteria	Patients who meet all of the following criteria are included. 1. Patients aged 20 to 80 2. Patients diagnosed with CTEPH 3.Patients who are planning to undergo BPA and are taking the therapeutic drug riociguat 4. Persons who have obtained consent for this research by signing the consent form
	Exclusion Criteria	Patients who fall under any of the following will not be included in this study. 1. Persons with serious liver disease 2. Persons with serious kidney disease 3. Women who are pregnant or may become pregnant 4. Lactating women 5. Other persons who are judged to be inappropriate by the principal investigator and the coordinator
	Age Minimum	20age old over
	Age Maximum	80age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		CTEPH
Intervention(s)		Right heart catheterization on the day before BPA treatment and 3 months after BPA treatment, except at the time of blood sampling, which is usually performed in clinical practice. During hospitalization, 5 ml / dose of blood is taken 6 times (before and 30 minutes after taking the drug). , 1 hour after taking the drug, 2 hours after taking the drug, 3 hours after taking the drug, 5 hours after taking the drug).
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Area under the time curve (AUC) of Riociguat before and after BPA
Secondary Outcome(s)		Pharmacokinetic parameters of riociguat before and after BPA (Cmax, Tmax, elimination half-life, trough blood concentration) Lung clearance, adverse events, AUC and pharmacokinetic parameters, influence factor analysis on lung clearance

Primary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Ethics Committee of Hamamatsu University School of Medicine
Address	1-20-1 Handayama Higashiku Hamamatsu city, Shizuoka
Telephone	+81-53-435-2680
E-Mail	kenkyou.s@hama-med.ac.jp
Approval Status	Approval
Date of approval	Feb. 02, 2021

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none