86. 肺動脈性肺高血圧症 Pulmonary arterial hypertension Clinical trials / Disease details
臨床試験数 : 1,205 / 薬物数 : 684 - (DrugBank : 124) / 標的遺伝子数 : 100 - 標的パスウェイ数 : 193
| 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 | NCT05679570 (ClinicalTrials.gov) | July 12, 2022 | 4/12/2022 | Satralizumab in the Treatment of Pulmonary Arterial Hypertension (SATISFY-JP Trial) | Satralizumab,an Anti-IL-6 Receptor Antibody, in the Treatment of Pulmonary Arterial Hypertension; Safety and Efficacy Evaluation in Japan -Multicenter, Investigator-sponsored Trial- | Pulmonary Arterial Hypertension | Drug: Satralizumab (Genetical Recombination) | International University of Health and Welfare | Japan Agency for Medical Research and Development;Keio University | Recruiting | 20 Years | 79 Years | All | 24 | Phase 2 | Japan |
| 2 | JPRN-jRCT2031210626 | 15/02/2022 | 23/02/2022 | SATISFY-JP Trial | Satralizumab, an Anti-IL-6 receptor antibody, in the treatment of pulmonary arterial hypertension; safety and efficacy evaluation in Japan - Multicenter, Investigator-sponsored Trial- - SATISFY-JP Trial | Pulmonary Arterial Hypertension;D006976 | The trial will consist of three periods: a screening period (within 30 days), an efficacy evaluation period (24 weeks), and a continuous administration period (28 weeks). Screening period Written consent will be obtained from patients with PAH who have immune responsive-phenotype and inadequate response to existing drugs. After obtaining consent, screening tests related to the study will be conducted to determine eligibility for the study. Baseline testing will be conducted between enrollment and the start of study drug administration. Efficacy Evaluation Period The study drug will be administered at a dose of 120 mg subcutaneously at initial, 2-week, 4-week, and 4-week intervals thereafter. Efficacy will be assessed after 24 weeks of study drug administration. Subjects who demonstrate efficacy and wish to continue treatment will receive the study drug for 24 weeks and moving to the continuous treatment period. In all other cases, the study will be terminated after 24 weeks of the efficacy evaluation period without the administration of study drug. Continuation Dosing Period Subjects who demonstrate efficacy during the efficacy evaluation period and wish to continue will receive continued treatment with satralizumab at a dose of 120 mg subcutaneously every 4 weeks. | Tamura Yuichi | NULL | Recruiting | >= 20age old | < 80age old | Both | 24 | Phase 2 | Japan |