Clinical Research Directory
Browse clinical research sites, groups, and studies.
Satralizumab in the Treatment of Pulmonary Arterial Hypertension (SATISFY-JP Trial)
Sponsor: International University of Health and Welfare
Summary
Examine the efficacy of satralizumab in patients with pulmonary arterial hypertension (PAH) with immune-responsive phenotype serum interleukin-6 (IL-6) ≥ 2.73 pg/mL who have an inadequate response to existing drugs.
Official title: Satralizumab,an Anti-IL-6 Receptor Antibody, in the Treatment of Pulmonary Arterial Hypertension; Safety and Efficacy Evaluation in Japan -Multicenter, Investigator-sponsored Trial-
Key Details
Gender
All
Age Range
20 Years - 79 Years
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2022-07-12
Completion Date
2026-06-30
Last Updated
2025-09-03
Healthy Volunteers
No
Conditions
Interventions
Satralizumab (Genetical Recombination)
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\[1\]: Subjects who demonstrate efficacy during the efficacy evaluation period and wish to continue will receive continued 28 weeks (52 weeks total) treatment with satralizumab. Continuation Dosing Period\[2\]: Subjects completed continuation dosing period\[1\], clinically capable of continued administration, and wish to continue will receive continued treatment with satralizumab until the end of this study period.
Locations (9)
Kagoshima University Hospital
Kagoshima, Kagoshima-ken, Japan
Chiba University Hospital
Chiba, Japan
Kyushu University Hospital
Fukuoka, Japan
Kobe University Hospital
Kobe, Japan
Kurume University Hospital
Kurume, Japan
Kyorin University Hospital
Mitaka, Japan
Nagoya University Hospital
Nagoya, Japan
Hokkaido University Hospital
Sapporo, Japan
International University of Health and Welfare Mita Hospital
Tokyo, Japan