Satralizumab in the Treatment of Pulmonary Arterial Hypertension (SATISFY-JP Trial)

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

July 12, 2022

Primary Completion Date

June 30, 2026

Study Completion Date

June 30, 2026

Conditions
Pulmonary Arterial Hypertension
Interventions
DRUG

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."

Trial Locations (9)

890-8520

Kagoshima University Hospital, Kagoshima

260-8677

Chiba University Hospital, Chiba

812-8582

Kyushu University Hospital, Fukuoka

650-0017

Kobe University Hospital, Kobe

830-0011

Kurume University Hospital, Kurume

181-8611

Kyorin University Hospital, Mitaka

466-8560

Nagoya University Hospital, Nagoya

060-8648

Hokkaido University Hospital, Sapporo

108-8329

International University of Health and Welfare Mita Hospital, Tokyo

All Listed Sponsors
collaborator

Japan Agency for Medical Research and Development

OTHER_GOV

collaborator

Keio University

OTHER

collaborator

Chugai Pharmaceutical

INDUSTRY

lead

International University of Health and Welfare

OTHER