Status:
COMPLETED
Efficacy and Safety Study of GB-0998 for Treatment of Systemic Sclerosis
Lead Sponsor:
Benesis Corporation
Conditions:
Scleroderma, Systemic
Eligibility:
All Genders
16+ years
Phase:
PHASE3
Brief Summary
This randomized, double-blind, placebo-controlled multi-center study will carry out to assess the efficacy of GB-0998 in the treatment of the systemic sclerosis based on the changes in modified Rodnan...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2009
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00348296
Start Date
July 1 2006
End Date
July 1 2009
Last Update
July 30 2010
Active Locations (1)
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1
Nagasaki University
Nagasaki, Nagasaki, Japan, 852-8501