心不全患者におけるポンセグロマブの研究
基本情報
- NCT ID
- NCT05492500
- ステータス
- 中止
- 試験のフェーズ
- 第2相
- 試験タイプ
- 介入
- 目標被験者数
- 455
- 治験依頼者名
- Pfizer
概要
The primary purpose of this clinical trial is to compare the effects of study medicine (Ponsegromab/PF-06946860) with a placebo (an injection that looks like the study medicine but does not contain the active medicine) to find out if the study medicine is better than the placebo (an injection that looks like the study medicine but does not contain the active medicine) for treatment of symptoms related to heart failure. Participants will not know which treatment group they are assigned to. Most participants in this study will receive the study medicine or placebo by shots under the skin every four weeks. People may be able to participate in this study if they have heart failure. Participants will take part in this study for about 9 months. During this time participants will visit the study clinic once a month. A separate PK cohort within this clinical trial will receive open-label study medicine (Ponsegromab/PF-06946860) only. Participants in this open-label, PK cohort will not receive placebo. These participants will receive the study medicine by shots under the skin every four weeks. People may be able to participate in this study cohort if they also have heart failure. Participants will take part in the open-label, PK cohort for about 7 months.
対象疾患
介入
依頼者(Sponsor)
実施施設 (10)
兵庫県立はりま姫路総合医療センター
Himeji, Hyōgo, Japan
National Hospital Organization Saitama Hospital
Wako, Saitama, Japan
医療法人徳洲会岸和田徳洲会病院
Kishiwada, Osaka, Japan
国立研究開発法人 国立循環器病研究センター
Suita, Osaka, Japan
岩手県立中央病院
Morioka, Iwate, Japan
医療法人 愛心会 東宝塚さとう病院
Takarazuka, Hyōgo, Japan
地方独立行政法人 大阪府立病院機構 大阪急性期・総合医療センター
Osaka, Japan
兵庫県立尼崎総合医療センター
Amagasaki, Hyōgo, Japan
独立行政法人国立病院機構仙台医療センター
Sendai, Miyagi, Japan
慶應義塾大学病院
Shinjuku-ku, Tokyo, Japan