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A Randomized, Double-blind Placebo-controlled Study of Recombinant Human B Lymphocyte Stimulating Factor Receptor-Fc Fusion Protein for the Treatment of Connective Tissue Disease-associated Thrombocytopenia
The goal of this clinical trial is to evaluate the efficacy and safety of Telitacicept for the treatment of connective tissue disease-associated thrombocytopenia.
Details
| Lead sponsor | Beijing Hospital |
|---|---|
| Phase | Phase 2 |
| Status | RECRUITING |
| Enrolment | 296 |
| Start date | 2023-12-02 |
| Completion | 2025-12 |
Conditions
- Connective Tissue Diseases
- Thrombocytopenia
Interventions
- Telitacicept
- Placebo
Primary outcomes
- Overall response (CR + PR) rate — at week 24
Response is deemed as complete (CR) if the platelet (PLT) count is ≥ 100×10\^9/L, partial (PR) if the platelet count ranges from 50×10\^9/L to 100×10\^9/L and at least doubled from baseline. No active bleeding is allowed in participants classified as CR or PR.
Countries
China