drugset / Trial / NCT04182373
KW-3357 Study in Patients With Early Onset Severe Preeclampsia
RandomizedParallel-groupDouble-blindTreatment
Summary
The purpose of this study is to evaluate the efficacy of intravenous KW-3357 in patients with early-onset severe preeclampsia by comparing the prolongation days of pregnancy with that of placebo.
Timeline
- Start
- 2019-11-19
- Primary completion
- 2023-05-17
- Completion
- 2023-06-16
Outcome
Missed primary endpoint
paper Pregnancy was prolonged by 13 days (95% CI, 10.4-15.6) in the placebo group and 16.9 days (95% CI, 13.8-20.0) in the rhAT-gamma group (P=0.07). PMID 41789451 ↗
release “for the treatment of preeclampsia in Japan did not meet the primary endpoint.” kyowakirin.com ↗
Publications
- Background Saito S, Takagi K, Moriya J, Kobayashi T, Kanayama N, Sameshima H, Morikawa M, Sago H, Adachi T, Ohkuchi A, Takeda S, Masuyama H, Seki H. A randomized phase 3 trial evaluating antithrombin gamma treatment in Japanese patients with early-onset severe preeclampsia (KOUNO-TORI study): Study protocol. Contemp Clin Trials. 2021 Aug;107:106490. doi: 10.1016/j.cct.2021.106490. Epub 2021 Jun 24.
- Takeda J, Tachibana D, Itakura A, Takagi K, Nakami S, Mano H, Kobayashi T, Kanayama N, Sameshima H, Morikawa M, Sago H, Adachi T, Ohkuchi A, Takeda S, Masuyama H, Seki H, Saito S; KOUNO-TORI Study Group. Randomized Study of Antithrombin in Early-Onset Preeclampsia: KOUNO-TORI Study. Hypertension. 2026 Jun;83(6):e25431. doi: 10.1161/HYPERTENSIONAHA.125.25431. Epub 2026 Mar 6.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Antithrombin gamma | Protein / enzyme biologic | 72 iu/kg | Intravenous |