drugset / Trial / NCT05737680

Hydroxychloroquine in Colchicine-Resistant Glucocorticoid-Dependent Idiopathic Recurrent Pericarditis

NCT05737680

Phase 3 Unknown 30 enrolled Hippocration General Hospital
RandomizedParallel-groupOpen-labelPrevention

Summary

Among patients with colchicine-resistant glucocorticoid-dependent idiopathic RP (idiopathic recurrent pericarditis during at least a second recurrence, having met the 2015 European Society of Cardiology criteria for pericarditis at least once), HCQ 400mg daily is associated with a reduce the risk of recurrence. The above hypothesis will be tested with a randomized, prospective, parallel, open label clinical trial. The expected study duration is approximately 12 months from the time the first subject is enrolled (planned for February 2023) to the time of study's termination date (December 2024). The researchers will obtain approval by the institutional review board (IRB).

Timeline

Start
2023-02
Primary completion
2024-12
Completion
2024-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Colchicine Small molecule
Comparator Hydroxychloroquine Small molecule 400 mg