NIPH Clinical Trials Search

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	Refractory Wegener's granulomatosis
Date of first enrollment	12/09/2005
Target sample size
Countries of recruitment
Study type	Interventional
Intervention(s)	investigational material(s) Generic name etc : Spanidin (Gusperimus, NKT-01) INN of investigational material : Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for Investigational material : Subcutaneous

Outcome(s)

Primary Outcome	Efficacy
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	<= 80age old
Gender	Both
Include criteria	Inclusion Criteria: Diagnosis of Wegener's granulomatosis according to the ACR criteria and the Chapel Hill Consensus Conference definition; BVAS >= 4; Treatment duration >= 3 months with CYC or >= 6 months with MTX; Age between 18 and 80 years; WBC >= 4,000/mm3. Exclusion Criteria: Pregnant or nursing mothers and women of childbearing age; Active bacterial/viral infection; History of HIV infection or active HBV or HCV infection.
Exclude criteria