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

Recurrent Miscarriage Clinical Trial

Official title:
A Double-Blind, Randomized, Placebo-Controlled Study of GB-0998 in Patients With Unexplained Recurrent Miscarriage.

Clinical Trial 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.

Clinical Trial Description

Among the patients whose risk factors for recurrent miscarriage are unknown who repeatedly miscarry or patients who repeatedly miscarry despite treatment for risk factors, those who have never given birth and have had four or more miscarriages. Patients were assigned into two groups, GB-0998 or placebo, and received 8 ml/kg body weight of GB-0998 (400 mg/kg body weight) or placebo once a day for 5 days. The primary efficacy endpoint was ongoing pregnancy rate at 22 weeks of gestation (excluding miscarriages associated with fetal chromosomal abnormalities) and one of the secondary endpoint was live birth rate. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02184741
Study type Interventional
Source Japan Blood Products Organization
Contact
Status Completed
Phase Phase 3
Start date June 3, 2014
Completion date September 2020
View Details
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