A randomized phase 3 trial evaluating antithrombin gamma treatment in Japanese patients with early-onset severe preeclampsia (KOUNO-TORI study): Study protocol

Preeclampsia is a leading cause of maternal and perinatal morbidity and mortality. Several studies have demonstrated the beneficial effects of antithrombin replacement in patients with preeclampsia. Here, we describe the study protocol of KOUNO-TORI (KW-3357 randOmized, mUlti-center, double-bliNd, p...

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Bibliographic Details
Published in:Contemporary clinical trials 2021-08, Vol.107, p.106490-106490, Article 106490
Main Authors: Saito, Shigeru, Takagi, Kenichi, Moriya, Junji, Kobayashi, Takao, Kanayama, Naohiro, Sameshima, Hiroshi, Morikawa, Mamoru, Sago, Haruhiko, Adachi, Tomoko, Ohkuchi, Akihide, Takeda, Satoru, Masuyama, Hisashi, Seki, Hiroyuki
Format: Article
Language:English
Subjects:
Antithrombin gamma
Antithrombins
Clinical Trials, Phase III as Topic
Double-Blind Method
Female
Gestational Age
Humans
Hypertension
Infant, Newborn
Japan
Pre-Eclampsia - drug therapy
Preeclampsia
Pregnancy
Randomized Controlled Trials as Topic
Randomized phase 3 trial
Study protocol
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Summary:Preeclampsia is a leading cause of maternal and perinatal morbidity and mortality. Several studies have demonstrated the beneficial effects of antithrombin replacement in patients with preeclampsia. Here, we describe the study protocol of KOUNO-TORI (KW-3357 randOmized, mUlti-center, double-bliNd, placebO-controlled phase 3 sTudy in patients with early Onset pReeclampsIa) to evaluate recombinant human antithrombin gamma (rhAT-gamma) for the treatment of early-onset severe de novo preeclampsia. Patients with early-onset severe de novo preeclampsia who are ≥24 to
ISSN:1551-7144
1559-2030
DOI:10.1016/j.cct.2021.106490