A Double-Blind, Randomized, Placebo-Controlled Study of GB-0998 in Patients With Unexplained Recurrent Miscarriage.
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 99
- Locations
- 1
- Primary Endpoint
- Ongoing pregnancy rate (excluding miscarriages associated with fetal chromosomal abnormalities)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- — to 41 Years (Child, Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- •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
Arms & Interventions
Placebo
Infusion of normal saline
Intervention: Placebo (Drug)
GB-0998
Infusion of GB-0998 (Immunoglobulin)
Intervention: GB-0998 (Drug)
Outcomes
Primary Outcomes
Ongoing pregnancy rate (excluding miscarriages associated with fetal chromosomal abnormalities)
Time Frame: 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 Outcomes
- Ongoing pregnancy rate(all patients)(At 22 weeks of gestation)
- Live birth rate (excluding miscarriages associated with fetal chromosomal abnormalities)(At the time of birth)
- Live birth rate(all patients)(At the time of birth)