Phase II study on NKT-01 in patients with refractory Wegener's granulomatosis
Phase 2
- Conditions
- Refractory Wegener's granulomatosis
- Registration Number
- JPRN-jRCT2080220107
- Lead Sponsor
- ippon Kayaku Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- Not specified
Inclusion 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy
- Secondary Outcome Measures
Name Time Method