NCT02184741

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 99 (actual)
• Sponsor: Japan Blood Products Organization · Industry
• Sex: Female
• Age: 41 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Recurrent Miscarriage

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2014-06-03
• Primary completion: 2020-05-01
• Completion: 2020-09-01
• First posted: 2014-07-09
• Last updated: 2022-01-28

Locations

1 site across 1 country: Japan