A Study of the Efficacy and Safety of GB-0998 in Patients With Unexplained Recurrent Miscarriage (NCT02184741) | Clinical Trial Compass
CompletedPhase 3
A Study of the Efficacy and Safety of GB-0998 in Patients With Unexplained Recurrent Miscarriage
Japan99 participantsStarted 2014-06-03
Plain-language 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.
Who can participate
Age range41 Years
SexFEMALE
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Inclusion criteria
✓. Patients with primary recurrent miscarriage
✓. Patients with a history of at least 4 miscarriages (not including biochemical pregnancy in the count of prior miscarriages)
✓. Patients with any of the following risk factors for recurrent miscarriage
✓. Abnormal uterine morphology
✓. Thyroid dysfunction
✓. Chromosome abnormality in the couple
✓. Positive antiphospholipid antibody
✓. Factor XII deficiency
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
✕
What they're measuring
1
Ongoing pregnancy rate (excluding miscarriages associated with fetal chromosomal abnormalities)
. 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