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 range
41 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Ongoing pregnancy rate (excluding miscarriages associated with fetal chromosomal abnormalities)
. 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