A Study of the Efficacy and Safety of GB-0998 in Patients With Unexplained Recurrent Miscarriage
- Registration Number
- NCT02184741
- Lead Sponsor
- Japan Blood Products Organization
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 99
Not provided
- Patients with chromosome abnormalities in themselves or their partners that are risk factors for recurrent miscarriage, patients with antiphospholipid syndrome, and patients with incidentally positive antiphospholipid antibody (when the latest test result is positive)
- Patients in whom complications of diabetes mellitus or impaired glucose tolerance has been identified, but who have not received appropriate treatment for this condition
- Patients who have received intravenous immunoglobulin therapy as treatment for recurrent miscarriage in the past
- Patients with a history of stillbirth at 22 weeks of gestation or later
- Patients receiving treatment for malignant tumor
- Patients with a history of thromboembolism
- Patients with a history of shock or hypersensitivity in response to the ingredients of this drug or patients with hereditary fructose intolerance
- Patients who have been diagnosed with IgA deficiency in the past or patients who have a serum IgA level of <5 mg/dL at laboratory tests at registration
- Patients who have received another study drug within the period of 12 weeks prior to informed consent or who are currently participating in another clinical trial
- Patients who are unsuitable for this study for any other reason, in the opinion of a principal investigator or sub-investigators
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Infusion of normal saline GB-0998 GB-0998 Infusion of GB-0998 (Immunoglobulin)
- Primary Outcome Measures
Name Time Method Ongoing pregnancy rate (excluding miscarriages associated with fetal chromosomal abnormalities) At 22 weeks of gestation To evaluate the effectiveness of the drug in preventing miscarriages, we examined the ongoing pregnancy rate at 22 weeks and 0 days of gestation in cases excluding cases of fetal chromosome aberration miscarriages.
- Secondary Outcome Measures
Name Time Method Ongoing pregnancy rate(all patients) At 22 weeks of gestation To evaluate the effectiveness of the drug in preventing miscarriages, we examined the ongoing pregnancy rate at 22 weeks and 0 days of gestation in all patients.
Live birth rate (excluding miscarriages associated with fetal chromosomal abnormalities) At the time of birth To evaluate the effectiveness of the drug in total outcome of pregnancy, we examined the live birth rate in cases excluding cases of fetal chromosome aberration miscarriages.
Live birth rate(all patients) At the time of birth To evaluate the effectiveness of the drug in total outcome of pregnancy, we examined the live birth rate in all patients.
Trial Locations
- Locations (1)
Japan Blood Products Organization
🇯🇵Tokyo, Japan
Japan Blood Products Organization🇯🇵Tokyo, Japan