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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00348296 |
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Date of registration:
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03/07/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Efficacy and Safety Study of GB-0998 for Treatment of Systemic Sclerosis
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Scientific title:
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A Randomized, Double-blind, Placebo-controlled Multi-center Study of GB-0998 for Treatment of Systemic Sclerosis |
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Date of first enrolment:
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July 2006 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00348296 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Japan
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Contacts
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Name:
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Kazuhiko Takehara, Professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Kanazawa University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients who have sclerosis located proximal to the elbow joint with diffused
systemic scleroderma.
- Patients who have not less than 20 points of TSS.
- Patients with no appropriate therapeutic treatment.
Exclusion Criteria:
- Patients with severe hepatic disorder, severe renal disorder or severe heart
disorder.
- Patients with malignant tumors.
- Patients who have the anamnesis of shock or hypersensitivity to this drug.
- Patients who have the anamnesis of cerebral infarction or symptom of these diseases.
- Patients who have been diagnosed as IgA deficiency in their past history.
- Pregnant, lactating, and probably pregnant patients, and patients who want to become
pregnant.
- Patients who had any dose increase or new dosing of steroid within 12 weeks before
consent.
- Patients who were administered other investigational drug within 12 weeks before
consent.
Age minimum:
16 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Scleroderma, Systemic
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Intervention(s)
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Drug: High-dose intravenous immunoglobulin (Venoglobulin-IH)
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Primary Outcome(s)
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Changes in TSS at 12 weeks
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Secondary Outcome(s)
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Changes in joint motion, oral aperture, active hand spread, fingertip-to-palm distance, health assessment questionnaire, histological analysis of dermal section at 12 weeks.; Adverse events and laboratory test.
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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