A Study of the Efficacy and Safety of GB-0998 in Patients With Unexplained Recurrent Miscarriage

Phase 3 Completed 99 enrolled Japan Blood Products Organization

RandomizedParallel-groupDouble-blindTreatment

Summary

The present survey was conducted to evaluate the efficacy and safety of GB-0998(immunoglobulin) in the treatment of unexplained recurrent miscarriage in comparison to placebo using a multicenter, double-blind, intergroup comparison method.

Timeline

Start: 2014-06-03
Primary completion: 2020-05
Completion: 2020-09

Outcome

Met primary endpoint

paper The ongoing pregnancy rate at 22 weeks of gestation (31/50 [62·0%] vs. 17/49 [34·7%]; odds ratio [OR] 3·07, 95% CI 1·35-6·97; p = 0·009) PMID 35795714 ↗

Publications

Yamada H, Deguchi M, Saito S, Takeshita T, Mitsui M, Saito T, Nagamatsu T, Takakuwa K, Nakatsuka M, Yoneda S, Egashira K, Tachibana M, Matsubara K, Honda R, Fukui A, Tanaka K, Sengoku K, Endo T, Yata H. Intravenous immunoglobulin treatment in women with four or more recurrent pregnancy losses: A double-blind, randomised, placebo-controlled trial. EClinicalMedicine. 2022 Jun 29;50:101527. doi: 10.1016/j.eclinm.2022.101527. eCollection 2022 Aug.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	GB-0998	Protein / enzyme biologic	400 mg/kg	Intravenous