Trial Profile

A Multicenter, Randomized, Open-lable, Parallel-controlled, Phase I/II Trial to Study Efficacy and Safety of Partial Substitution of Glucocorticoid for BDB-001 Injection in Patients With ANCA-associated Vasculitis

Status: Recruiting

Phase of Trial: Phase I/II

Latest Information Update: 28 Aug 2024

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At a glance

Drugs BDB 001 Beijing Defengrei Biotechnology (Primary) ; Cyclophosphamide; Prednisone
Indications Granulomatosis with polyangiitis; Vasculitis
Focus Therapeutic Use
Sponsors Staidson Beijing BioPharmaceuticals

11 Oct 2023 Planned number of patients changed from 60 to 100.
11 Oct 2023 Planned End Date changed from 1 Sep 2023 to 1 Mar 2025.
11 Oct 2023 Planned primary completion date changed from 1 Sep 2023 to 1 Mar 2025.

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