Optimal Dose of Zanubrutinib to Treat Adult Immune Thrombocytopenia
ConditionImmune Thrombocytopenia
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorPeking University People's Hospital
About this trial
The goal of this clinical trial is to find the best dose of zanubrutinib when used together with high-dose dexamethasone for adults who are newly diagnosed with primary immune thrombocytopenia (ITP), and to learn how safe and effective this combination treatment is.
Eligibility criteria
Qualifiers
Confirmed newly-diagnosed, treatment-naive ITP;
Platelet counts <30×10^9/L ;
Platelet counts < 50×10^9/L and significant bleeding symptoms (WHO bleeding scale 2 or above);
Willing and able to sign written informed consent.
Disqualifiers
Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 6 months before the screening visit;
Received first-line and second-line ITP-specific treatments (eg, steriods, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) ;
Current HIV infection or hepatitis B virus or hepatitis C virus infections;
Active infection;
Trial design
Treatments tested in this trial
- Zanubrutinib 80mg/d
- High dose dexamethasone
- Zanubrutinib 160mg/d
- Zanubrutinib 240mg/d
Treatment groups
60 Participants
are divided into 3 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov