A Prospective, One-arm and Open Clinical Study of Obinutuzumab in the Treatment of Pediatric 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.
At a Glance
- Age
- 12 – 18
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 60 (estimated)
- Sponsor
- Institute of Hematology & Blood Diseases Hospital, China · Other
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About This Trial
To evaluate the safety and efficacy of Obinutuzumab in the treatment of pediatric primary immune thrombocytopenia in patients who have not responded adequately or relapsed after first-line glucocorticoid treatment.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Age 12-18 years old, male or female
* Conform to the diagnostic criteria of persistent or chronic immune Thrombocytopenia (ITP)
* With a platelet count of \<30 X 10\^9/L measured within 2 days prior to administration(Platelet counts were measured at least 2 times during screen…
Contacts