Trials / Completed
CompletedNCT05197842
Efficacy and Safety of Substitution of Glucocorticoid for BDB-001 Injection in Patients With Anti-neutrophil Cytoplasmic Antibody(ANCA)-Associated Vasculitis
A Multicenter, Randomized, Open-lable, Parallel-controlled, Phase I/II Trial to Study Efficacy and Safety of Substitution of Glucocorticoid for BDB-001 Injection in Patients With ANCA-associated Vasculitis
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 93 (actual)
- Sponsor
- Staidson (Beijing) Biopharmaceuticals Co., Ltd · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The aim of the trial is to study the efficacy and safety of treatment with BDB-001 Injection substitution of glucocorticoid in patients with ANCA-associated vasculitis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BDB-001 injection | Intravenously administered |
| DRUG | Cyclophosphamide | Intravenously administered |
| DRUG | Glucocorticoids | Orally administered |
Timeline
- Start date
- 2022-02-22
- Primary completion
- 2025-03-19
- Completion
- 2025-03-19
- First posted
- 2022-01-20
- Last updated
- 2025-08-07
Locations
22 sites across 1 country: China
Source: ClinicalTrials.gov record NCT05197842. Inclusion in this directory is not an endorsement.