Pharmacokinetic changes in Riociguat before and after catheterization

JRCT ID: jRCT1041200111

Registered date:11/03/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: CTEPH
• Date of first enrollment: 11/03/2021
• Target sample size: 30
• Study type: Interventional
• 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).

Outcome(s)

• Primary Outcome: Area under the time curve (AUC) of Riociguat before and after BPA
• Secondary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 80age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Tatsuguchi Mariko