88. 慢性血栓塞栓性肺高血圧症 Chronic thromboembolic pulmonary hypertension Clinical trials / Disease details
臨床試験数 : 157 / 薬物数 : 107 - (DrugBank : 22) / 標的遺伝子数 : 14 - 標的パスウェイ数 : 54
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT05140525 (ClinicalTrials.gov) | June 1, 2023 | 28/10/2021 | Effects of Combination Medical Therapy Followed by BPA on Right Ventricular-PA Coupling and Hemodynamics in CTEPH | Effects of Combination Medical Therapy Followed by Balloon Pulmonary Angioplasty on Right Ventricular-PA Coupling and Hemodynamics in Chronic Thromboembolic Pulmonary Hypertension | CTEPH | Drug: Macitentan Tablets;Drug: Riociguat;Device: balloon pulmonary angioplasty | Dr Sudarshan Rajagopal | Actelion | Not yet recruiting | 18 Years | N/A | All | 15 | Phase 3 | United States |
| 2 | ChiCTR2100052570 | 2021-08-01 | 2021-10-31 | A randomized controlled study of the effectiveness of percutaneous pulmonary thrombotic tissue aspiration in improving pulmonary blood flow grading in patients with chronic thromboembolic pulmonary hypertension | A randomized controlled study of the effectiveness of percutaneous pulmonary thrombotic tissue aspiration in improving pulmonary blood flow grading in patients with chronic thromboembolic pulmonary hypertension | Chronic Thromboembolic Pulmonary Hypertension | Control group:Traditional simple BPA procedure;Experimental group:Traditional simple BPA + thrombotic tissue removal; | Fuwai Hospital, Chinese Academy of Medical Sciences | NULL | Recruiting | 18 | 80 | Both | Control group:20;Experimental group:20; | China | |
| 3 | JPRN-jRCTs041200052 | 30/06/2021 | 22/10/2020 | THERAPY-HYBRID-BPA trial | The Effect of Riociguat for Peak Cardiac Index on Cardiopulmonary Exercise Test in Chronic Thromboembolic Pulmonary Hypertension (CTEPH) Patients after Normalization of Pulmonary Artery Pressure by Combination Treatment of Riociguat and Balloon Pulmonary Angioplasty. - Riociguat-CTEPH | chronic thromboembolic pulmonary hypertension CTEPH;D000081029 | In this study, we will perform continuous verification by allocating the Chronic Thromboembolic Pulmonary Hypertension (CTEPH) patients whose hemodynamics were normalized after Balloon Pulmonary Angioplasty (BPA) to the the riociguat active group and placebo group for 16 weeks. | Shimokawahara Hiroto | NULL | Recruiting | >= 18age old | < 85age old | Both | 72 | Phase 2 | Japan |
| 4 | JPRN-jRCT1041200111 | 11/03/2021 | 11/03/2021 | Pharmacokinetic changes in Riociguat before and after catheterization | Effect of balloon pulmonary angioplasty on the pharmacokinetics of riociguat - BPA: Balloon Pulmonary Angiotherapy | CTEPH | 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). | Tatsuguchi Mariko | NULL | Recruiting | >= 20age old | <= 80age old | Both | 30 | N/A | Japan |
| 5 | ChiCTR2000032403 | 2021-01-01 | 2020-04-27 | Efficacy and safety of refined balloon pulmonary angioplasty combined with riociguat in the treatment of inoperable chronic thromboembolic pulmonary hypertension: a single center, open label, prospective, optimal, randomized, parallel controlled clinical study (PRACTICE study) | Efficacy and safety of refined balloon pulmonary angioplasty combined with riociguat in the treatment of inoperable chronic thromboembolic pulmonary hypertension: a single center, open label, prospective, optimal, randomized, parallel controlled clinical study (PRACTICE study) | chronic thromboembolic pulmonary hypertension | Riociguat Group:Riociguat;Riociguat+BPA Group:Riociguat and BPA; | Shanghai Pulmonary Hospital | NULL | Pending | 18 | Both | Riociguat Group:30;Riociguat+BPA Group:30; | China | ||
| 6 | NCT04600492 (ClinicalTrials.gov) | October 16, 2020 | 19/10/2020 | THERAPY-HYBRID-BPA Trial | The Effect of Riociguat for Peak Cardiac Index on Cardiopulmonary Exercise Test in CTEPH Patients After Normalization of Pulmonary Artery Pressure by Combination Treatment of Riociguat and Balloon Pulmonary Angioplasty | Hypertension, Pulmonary | Drug: Riociguat Oral Tablet | National Hospital Organization Okayama Medical Center | Bayer Yakuhin, Ltd. | Recruiting | 18 Years | 85 Years | All | 72 | Phase 2 | Japan |
| 7 | ChiCTR2000034995 | 2019-06-01 | 2020-07-27 | Real world study on the changes of pulmonary perfusion in patients with chronic thromboembolic pulmonary hypertension treated with percutaneous balloon pulmonary angioplasty versus targeted drug therapy | Real world study on the changes of pulmonary perfusion in patients with chronic thromboembolic pulmonary hypertension treated with percutaneous balloon pulmonary angioplasty versus targeted drug therapy | pulmonary hypertension | BPA:BPA;Target Drug:Target Drug;BPA+Target Drug:BPA+Target Drug; | The First Affiliated Hospital of Guangzhou Medical University | NULL | Recruiting | 20 | 80 | Both | BPA:20;Target Drug:20;BPA+Target Drug:20; | N/A | China |
| 8 | JPRN-jRCTs031180239 | 14/04/2016 | 12/03/2019 | MR BPA study | Multicenter Randomized controlled trial based on Balloon Pulmonary Angioplasty for chronic thromboembolic pulmonary hypertension - MR BPA study | Chronic Thromboembolic Pulmonary Hypertension | Group A: BPA treatment BPA is performed after allocation to this group (initial date of implementation will be the reference date). BPA will be completed within four months of the reference date. Group B: Riociguat treatment Riociguat treatment will be initiated after allocation to this group (the initial administration day will be the reference date). Riociguat will be initially administered three times per day at 1.0 mg per dose. Using systolic blood pressure (95 mmHg or higher) as a guide, the dose will be increased by 0.5 mg for each subject every two weeks with a thrice-daily administration of 2.5 mg/dose set as the maximum dosage. Dosage adjustment, including the maintenance dosage, is based on the judgment of the responsible investigators and investigators. Dosage adjustment will be completed within four months of the reference date. | Fukuda Keiichi | Kawakami Takashi | Complete | >= 20age old | <= 80age old | Both | 60 | N/A | Japan |
| 9 | JPRN-UMIN000019549 | 2016/04/01 | 28/10/2015 | Multicenter Randomized controlled trial based on Balloon Pulmonary Angioplasty for chronic thromboembolic pulmonary hypertension | Multicenter Randomized controlled trial based on Balloon Pulmonary Angioplasty for chronic thromboembolic pulmonary hypertension - Multicenter Randomized controlled trial based on Balloon Pulmonary Angioplasty for chronic thromboembolic pulmonary hypertension(MR BPA study) | Chronic thromboembolic pulmonary hypertension (CTEPH) | Group A: BPA treatment Basically BPA treatment needs to be finished within 4 months from the day of first BPA session Group B: Riociguat treatment First, starting with riociguat 3 times per day (1.0mg/time). Then increase the dose by 0.5mg every two weeks (with systolic blood pressure 95mmHg or higher). The maximum dose is 2.5mg per dose (three times per day). Dosage is adjusted accordingly for each patient, and the adjustment is finished within 4 months from the day of starting riociguat. | Keio University School of Medicine | NULL | Complete: follow-up continuing | 20years-old | 80years-old | Male and Female | 60 | Not selected | Japan |
| 10 | NCT02634203 (ClinicalTrials.gov) | January 19, 2016 | 8/12/2015 | Riociguat Versus Balloon Pulmonary Angioplasty in Non-operable Chronic thromboEmbolic Pulmonary Hypertension | Riociguat Versus Balloon Pulmonary Angioplasty in Non-operable Chronic thromboEmbolic Pulmonary Hypertension | Chronic Thromboembolic Pulmonary Hypertension | Procedure: Balloon Pulmonary Angioplasty (BPA);Drug: Riociguat | Assistance Publique - Hôpitaux de Paris | Bayer | Completed | 18 Years | 80 Years | All | 105 | N/A | France |