Recurrent MiscarriagePhase 3NCT02184741
A Study of the Efficacy and Safety of GB-0998 in Patients With Unexplained Recurrent Miscarriage
A Phase 3 study testing GB-0998 in people with Recurrent Miscarriage, run by Japan Blood Products Organization at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 41 years, women only
- Conditions the study is for
- Recurrent Miscarriage
- What is being tested?
- GB-0998
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 99 participants
- Where
- 1 siteJapan
- Study dates
- 3 Jun 2014to Sep 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 41 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
- 【Patients with unknown risk factors】 Patients with normal test results for each of the following risk factors who have experienced miscarriage of a fetus with normal chromosome karyotype
- Abnormal uterine morphology
- Thyroid dysfunction
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- Chromosome abnormality in the couple
- Positive antiphospholipid antibody
- Factor XII deficiency
- Protein S deficiency
- Protein C deficiency
- 【Patients determined to have risk factors】 Patients with the following risk factors who have experienced miscarriage of a fetus with normal chromosome karyotype despite receiving treatment for these factors
- Abnormal uterine morphology (septate uterus): Patients who have undergone surgery
- Thyroid dysfunction: Patients receiving medical treatment
- Incidentally positive antiphospholipid antibody, factor XII deficiency, protein S deficiency, protein C deficiency:Patients receiving combination therapy with aspirin and heparin 4．Regardless of whether or not risk factors are present, patients should have experienced at least 1 a miscarriage of a fetus with normal chromosome karyotype 5．Patients below the age of 42 years at the time of obtaining informed consent 6．Patients who can be admitted for at least the period from the start date of administration of the study drug to the date of examination and assessment 1 week after the start of administration of the study drug 7．Patients who have given written informed consent to participate in this study
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-Blind, Randomized, Placebo-Controlled Study of GB-0998 in Patients With Unexplained Recurrent Miscarriage.
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.
Read the 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
- Being tested
- GB-0998, Placebo
- Keywords
- IVIG, Unexplained Recurrent miscarriage, Primary Recurrent miscarriage, Intravenous immunoglobulin
- Medical subject headings
- Abortion, Habitual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GB-0998Drug
Also called Intravenous Immunoglobulin （Venoglobulin®IH，2.5g/50ml）
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.
PlaceboDrug
Also called normal saline
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.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Infusion of normal saline Receives: Drug: Placebo |
| GB-0998 | Experimental | Infusion of GB-0998 (Immunoglobulin) Receives: Drug: GB-0998 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ongoing pregnancy rate (excluding miscarriages associated with fetal chromosomal abnormalities)
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.
Measured: At 22 weeks of gestation
Secondary outcomes (3)
Ongoing pregnancy rate(all patients)
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.
Measured: At 22 weeks of gestation
Live birth rate (excluding miscarriages associated with fetal chromosomal abnormalities)
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.
Measured: At the time of birth
Live birth rate(all patients)
To evaluate the effectiveness of the drug in total outcome of pregnancy, we examined the live birth rate in all patients.
Measured: At the time of birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2014 (estimated)
- Study start3 Jun 2014
- Primary completionMay 2020
- Study completionSep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Recurrent MiscarriageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Japan Blood Products Organization
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hideto Yamada, Director, Principal investigator, Center for Recurrent Pregnancy Loss, Teine Keijinkai HospitalShigeru Saito, Professor, Principal investigator, University of Toyama
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02184741
- Sponsor's protocol ID
- B211-11
- Status last verified
- Oct 2021
- First submitted
- 3 Jul 2014
- Last updated
- 28 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Yamada H, Deguchi M, Saito S, Takeshita T, Mitsui M, Saito T, Nagamatsu T, Takakuwa K, Nakatsuka M, Yoneda S, Egashira K, Tachibana M, Matsubara K, Honda R, Fukui A, Tanaka K, Sengoku K, Endo T, Yata H. Intravenous immunoglobulin treatment in women with four or more recurrent pregnancy losses: A double-blind, randomised, placebo-controlled trial. EClinicalMedicine. 2022 Jun 29;50:101527. doi: 10.1016/j.eclinm.2022.101527. eCollection 2022 Aug.
PubMed 35795714
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Placebo-Controlled Study of GB-0998 in Patients With Unexplained Recurrent Miscarriage.
- ClinicalTrials.gov ID
- NCT02184741
- Acronym / sponsor ID
- B211-11
- Conditions
- Recurrent Miscarriage
- Keywords
- IVIG, Unexplained Recurrent miscarriage, Primary Recurrent miscarriage, Intravenous immunoglobulin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Japan Blood Products OrganizationIndustry (pharma, biotech, devices)
- Study start
- 3 Jun 2014 (actual)
- Primary completion
- May 2020 (actual)
- Study completion
- Sep 2020 (actual)
- First posted
- 9 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboInfusion of normal saline |
| GB-0998 | Experimental | Drug: GB-0998Infusion of GB-0998 (Immunoglobulin) |
Who may qualify
- Ages
- Up to 41 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (15 listed)
- 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
- 【Patients with unknown risk factors】 Patients with normal test results for each of the following risk factors who have experienced miscarriage of a fetus with normal chromosome karyotype
- Abnormal uterine morphology
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GB-0998Also: Intravenous Immunoglobulin （Venoglobulin®IH，2.5g/50ml）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 | GB-0998 |
| PlaceboAlso: normal salineSubjects 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. | Drug | Placebo |
Primary outcome
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.
3 secondary outcomes
Ongoing pregnancy rate(all patients)
Time frame: At 22 weeks of gestation
Live birth rate (excluding miscarriages associated with fetal chromosomal abnormalities)
Time frame: At the time of birth
Live birth rate(all patients)
Time frame: At the time of birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2022.
- Derived from this study: PubMed 35795714Yamada H, Deguchi M, Saito S, Takeshita T, Mitsui M, Saito T, Nagamatsu T, Takakuwa K, Nakatsuka M, Yoneda S, Egashira K, Tachibana M, Matsubara K, Honda R, Fukui A, Tanaka K, Sengoku K, Endo T, Yata H. Intravenous immunoglobulin treatment in women with four or more recurrent pregnancy losses: A double-blind, randomised, placebo-controlled trial. EClinicalMedicine. 2022 Jun 29;50:101527. doi: 10.1016/j.eclinm.2022.101527. eCollection 2022 Aug.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hideto Yamada, Director principal investigator
Center for Recurrent Pregnancy Loss, Teine Keijinkai Hospital
Shigeru Saito, Professor principal investigator
University of Toyama
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing GB-0998 in people with Recurrent Miscarriage, run by Japan Blood Products Organization at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ongoing pregnancy rate (excluding miscarriages associated with fetal chromosomal abnormalities) (time frame: At 22 weeks of gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02184741, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2022.