A Study of the Efficacy and Safety of GB-0998 in Patients With Unexplained Recurrent Miscarriage

NCT02184741 | Completed Phase 3

• 1 other identifier: B211-11
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

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.

Conditions

Recurrent Miscarriage

Keywords

IVIG; Unexplained Recurrent miscarriage; Primary Recurrent miscarriage; Intravenous immunoglobulin

Outcome Measures

Primary Outcomes (1)

• 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.

  At 22 weeks of gestation

Secondary Outcomes (3)

• 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

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Infusion of normal saline

Drug: Placebo

GB-0998

EXPERIMENTAL

Infusion of GB-0998 (Immunoglobulin)

Drug: GB-0998

Interventions

GB-0998 DRUG

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.

Also known as: Intravenous Immunoglobulin （Venoglobulin®IH，2.5g/50ml）

GB-0998

Placebo DRUG

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.

Also known as: normal saline

Placebo

Eligibility Criteria

• Age: Up to 41 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Japan Blood Products Organization: lead

Study Sites (1)

Japan Blood Products Organization

Tokyo, Japan

Location

Related Publications (1)

• 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.

  PMID: 35795714 DERIVED

MeSH Terms

Conditions

Abortion, Habitual

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Abortion, Spontaneous; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Hideto Yamada, Director

  Center for Recurrent Pregnancy Loss, Teine Keijinkai Hospital

  PRINCIPAL INVESTIGATOR

• Shigeru Saito, Professor

  University of Toyama

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2014
• First Posted: July 9, 2014
• Study Start: June 3, 2014
• Primary Completion: May 1, 2020
• Study Completion: September 1, 2020
• Last Updated: January 28, 2022

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)