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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

Heart Failure

介入

Main cohort (Cohort A): Ponsegromab low dose(DRUG)
Main cohort (Cohort A): Ponsegromab medium dose(DRUG)
Main cohort (Cohort A): ponsegromab high dose(DRUG)
Main cohort (Cohort A): Matched placebo(OTHER)
Open-label, PK Cohort (Cohort B): ponsegromab low dose(DRUG)
Open-label, PK Cohort (Cohort B): ponsegromab medium dose(DRUG)
Open-label, PK Cohort (Cohort B): ponsegromab high dose(DRUG)
Optional Cohort C: Ponsegromab low dose(DRUG)
Optional Cohort C: Matched placebo(OTHER)
Optional Cohort D: Ponsegromab high dose(DRUG)
Optional Cohort D: Matched placebo(OTHER)

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