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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: JPRN
Last refreshed on: 9 January 2020
Main ID:  JPRN-JapicCTI-132394
Date of registration: 25/12/2013
Prospective Registration: Yes
Primary sponsor: TEIJIN PHARMA LIMITED
Public title: Phase 3 study of GGS in patients with microscopic polyangiitis (MPA)
Scientific title: Randomized, placebo-controlled, double-blind, parallel-group clinical study of GGS in patients with microscopic polyangiitis (MPA) (Phase 3 study)
Date of first enrolment: 07/3/2014
Target sample size: 36
Recruitment status: complete
URL:  https://www.clinicaltrials.jp/user/showCteDetailE.jsp?japicId=JapicCTI-132394
Study type:  INTERVENTIONAL
Study design:  Multicenter, randomized, placebo-controlled, double-blind, parallel-group study design  
Phase:  3
Countries of recruitment
Japan
Contacts
Name: TEIJIN PHARMA LIMITED Pharmaceutical Development Administration Dept.   
Address: 
Telephone:
Email: clintrials@teijin.co.jp
Affiliation: 
Name: TEIJIN PHARMA LIMITED Pharmaceutical Development Administration Dept.   
Address: 
Telephone:
Email: clintrials@teijin.co.jp
Affiliation: 
Key inclusion & exclusion criteria
Inclusion criteria: Patients with microscopic polyangiitis associated with neuropathy

Main Inclusion Criteria
1.Patients diagnosed as "definite" or "probable" according to " Diagnostic Criteria of Microscopic Polyangiitis (MPA)" specified in the " Guideline for management of vasculitis syndrome " (JCS 2008)
2. Patients who have underwent the following steroid therapy for MPA
A: Patients who have underwent the following steroid therapy as remission induction therapy
1) Treatment with corticosteroid at 40 mg/day (or 0.6 mg/kg/day) as prednisolone for at least 2 weeks
2) Treatment with corticosteroid at 20 mg/day or higher for 8 weeks or longer including the above 1) following the above 1)
B: After the tapering following A, treatment with corticosteroid at a constant dose of 2.5 mg/day or higher and 15 mg/day or lower as prednisolone for at least 4 weeks until the day of consent
3. Patients for whom the presence of clinical symptoms of peripheral neuropathy (muscle weakness, pain, and numbness of the extremities, etc.) during remission induction therapy for MPA can be confirmed in medical records

Exclusion criteria: Main Exclusion Criteria
1. Patients with a history of shock or hypersensitivity to any human immunoglobulin preparation
2. Patients with IgA deficiency
3. Patients with hemolytic/blood loss anemia
4. Patients with reduced cardiac function
5. Patients with end-stage renal disease
6. Patients with cerebrovascular or cardiovascular disorder
7. Patients with a high risk of thromboembolism
8. Patients with immunodeficiency or under immunosuppression
9. Pregnant, potentially pregnant, or lactating patients
10. Patients who are being treated in other clinical study


Age minimum: 20
Age maximum:
Gender: BOTH
Health Condition(s) or Problem(s) studied
Microscopic polyangiitis (MPA)
Intervention(s)
Intervention name : Freeze-Dried Sulfonated Human Normal Immunoglobulin (GGS)
INN of the intervention : -
Dosage And administration of the intervention : Intravenous drip infusion
Control intervention name : Placebo (physiological saline)
INN of the control intervention : -
Dosage And administration of the control intervention : Intravenous drip infusion
Primary Outcome(s)
efficacy
Primary endopoint
Neuropathy

Evaluation method
Manual muscle test (MMT)
Secondary Outcome(s)
safety, efficacy
Main secondary endpoints
Efficacy
1. Neuropathy
2. Angiitis symptoms

Safety
1. Adverse events
2. Vital signs
3. Clinical laboratory tests

Evaluation method
Manual muscle test (MMT), BVAS (Birmingham Vasculitis Activity Score)
Secondary ID(s)
Source(s) of Monetary Support
TEIJIN PHARMA LIMITED
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date:
Contact:
Institutional Review Board of University of Tsukuba Hospital
Results
Results available:
Date Posted:
Date Completed:
URL:
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