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

PHASE3CompletedINTERVENTIONAL
Enrollment

99

Participants

Timeline

Start Date

June 3, 2014

Primary Completion Date

May 31, 2020

Study Completion Date

September 30, 2020

Conditions
Recurrent Miscarriage
Interventions
DRUG

GB-0998

Subjects received GB-0998 at 400 mg/kg body weight once daily for 5 days until 6 weeks and 6 days of gestation after confirmation of the gestational sac by ultrasonography.

DRUG

Placebo

Subjects received the same dose of saline as GB-0998 for 5 days after confirmation of the gestational sac by ultrasonography, up to 6 weeks and 6 days of gestation.

Trial Locations (1)

Unknown

Japan Blood Products Organization, Tokyo

All Listed Sponsors
lead

Japan Blood Products Organization

INDUSTRY