Status:
ACTIVE_NOT_RECRUITING
Subclinical Cytomegalovirus Reactivation in Acute ANCA-associated Vasculitis
Lead Sponsor:
University Hospital Birmingham NHS Foundation Trust
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
ANCA Associated Vasculitis
Eligibility:
All Genders
18+ years
Brief Summary
This is a prospective observational study to determine the frequency and magnitude of Cytomegalovirus (CMV) reactivation in patients with anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculi...
Detailed Description
INTRODUCTION/BACKGROUND: This is an observational study to determine the frequency and magnitude of CMV reactivation in patients with AAV in the acute phase of the disease (within 12 months of diagno...
Eligibility Criteria
Inclusion
- New diagnosis of AAV as evidenced by relevant biopsy and / or clinical diagnosis in the context of a positive ANCA antibody OR major relapse of previously diagnosed AAV that requires re-induction of remission treatment with intravenous rituximab or cyclophosphamide together with high dose oral corticosteroids
- Age \>18 years
- Willingness to participate in the study and attend clinic and study visits
- Able to provide written informed consent
Exclusion
- Strong suspicion of alternative diagnosis other than AAV
- Subjects who do not have capacity to consent to study participation as defined by the Mental Capacity Act 2005
- Inability or unwillingness to attend study visits
Key Trial Info
Start Date :
April 19 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 22 2025
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04916704
Start Date
April 19 2022
End Date
December 22 2025
Last Update
July 11 2024
Active Locations (1)
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1
University Hospitals Birmingham
Birmingham, West Midlands, United Kingdom, B15 2TH