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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: 2 April 2019
Main ID:  JPRN-JapicCTI-060242
Date of registration:
Prospective Registration: Yes
Primary sponsor: TEIJIN PHARMA LIMITED
Public title: Phase 3 study of GGS in patients with CSS/AGA
Scientific title: Double-blind, Randomized clinical study of GGS (Intravenous Immunoglobulin) in patients with CSS/AGA. Phase 3 study.
Date of first enrolment: 01/2/2006
Target sample size: 21
Recruitment status:
URL:  https://www.clinicaltrials.jp/user/showCteDetailE.jsp?japicId=JapicCTI-060242
Study type:  INTERVENTIONAL
Study design:  Multicenter, double-blind, randomized of treatment period  
Phase:  3
Countries of recruitment
Contacts
Name:    
Address: 
Telephone:
Email:
Affiliation: 
Name: TEIJIN PHARMA LIMITED Pharmaceutical Development Administration Department   
Address:  clintrials@teijin.co.jp
Telephone:
Email:
Affiliation: 
Key inclusion & exclusion criteria
Inclusion criteria: Patients with CSS/AGA associated with neuropathy responding poorly to traditional therapy (steroid therapy, etc.)
Main Inclusion Criteria
1.Patients with a diagnosis of definite CSS/AGA according to "Diagnostic criteria for allergic granulomatosus angiitis (Churg-Strauss Syndrome) proposed by the Research Committee of Intractable Vasculitis, Ministry of Health and Welfare, Japan (1998)"
2.Patients who have underwent the following steroid therapy for CSS/AGA
A:Treatment with corticosteroid at 40 mg/day as prednisolone for at least 4 weeks as remission induction therapy
B:After the tapering following A, treatment with corticosteroid at a constant dose of 5 mg/day or higher and 20 mg/day or lower as prednisolone for at least 4 weeks
3.Patients who have at least one impaired site with a manual muscle testing (MMT) score of not more than 3 and have a MMT sum score of not more than 130

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 serious renal disorder
4.Patients with cerebrovascular or cardiovascular disorder or its history
5.Patients with a high risk of thromboembolism
6.Patients with hemolytic/blood loss anemia
7.Patients with reduced cardiac function
8.Patients with immunodeficiency or under immunosuppression
9.Pregnant, potentially pregnant, or lactating patients
10.Patients who are being treated in other clinical study or who complete other clinical study within the last 4 weeks


Age minimum: 20
Age maximum: 74
Gender: BOTH
Health Condition(s) or Problem(s) studied
Churg-Strauss Syndrome (CSS) / Allergic Granulomatous Angiitis (AGA)
Intervention(s)
Intervention name : Freeze-Dried Sulfonated Human Normal Immunoglobulin (GGS)
Dosage And administration of the intervention : Intravenous drip infusion
Control intervention name : Placebo (physiological saline)
Dosage And administration of the control intervention : Intravenous drip infusion
Primary Outcome(s)
Neuropathy
Manual muscle test (MMT)
Secondary Outcome(s)
Main secondary endpoints
Efficacy
1. Neuropathy

Safety
1. Subjective symptoms
2. Objective findings
3. Clinical laboratory tests
Manual muscle test (MMT), Modified Barthel Index, VAS (Visual Analogue Scale)
Secondary ID(s)
Source(s) of Monetary Support
TEIJIN PHARMA LIMITED
Secondary Sponsor(s)
Ethics review
Status:
Approval date:
Contact:
Results
Results available:
Date Posted:
Date Completed:
URL:
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