Anti-CD38 Monoclonal Antibody Versus Rituximab in the Management of Primary Immune Thrombocytopenia (ITP)

Recruiting Phase 2 Interventional Study
Immune Thrombocytopenia Treatment
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
160 (estimated)
Sponsor
Institute of Hematology & Blood Diseases Hospital, China · Other
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About This Trial

This randomized, open-label study aim to compare the efficacy and safety of Daratumumab (anti-CD38 monoclonal antibody) with rituximab in ITP patients.This study will be conducted in ITP patients who had not responded to or had relapsed after previous glucocorticoid treatment.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Age ≥18 years, male or female. * Before enrollment, the subjects have been clinically diagnosed with primary immune thrombocytopenia for no less than three months according to the American Society of Hematology guidelines 2011 Evidence-Based Practice Guideline (Neunert et al. …
Contacts

Lei Zhang, MD

+8613502118379

zhanglei1@ihcams.ac.cn

CONTACT

Yunfei Chen, MD

+8618502220788

chenyunfei@ihcams.ac.cn

CONTACT