Status:
UNKNOWN
A Clinical Study on the Efficacy and Safety of HBM9161 in Patients With ITP
Lead Sponsor:
Harbour BioMed (Guangzhou) Co. Ltd.
Conditions:
Primary Immune Thrombocytopenic Purpura
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
To select a dose and to make a decision for Phase 3 study
Detailed Description
The onset of primary immune thrombocytopenia is thought to be increased platelet destruction and decreased platelet production due to anti-platelet antibodies. HBM9161 is a fully human anti-FcRn monoc...
Eligibility Criteria
Inclusion
- ≥ 18 years of age at the screening visit, male or female.
- Persistent or chronic ITP whose average number of platelet at the screening visit and pre-dose (at least 1 day apart) is \< 30 × 10\^9/L, and not \> 35 × 10\^9/L for any of two tests. No severe bleeding within 4 weeks prior to the screening visit.
- Patients who have received and failed at least 1 first line of ITP therapy (glucocorticoids and/or intravenous gamma globulin), or who are contraindicated, intolerable, or refuse standard therapy.
- Patients will be allowed to use a stable dose of concomitant drugs for the treatment of ITP. e.g., glucocorticoid, danazol, immunosuppressant (azathioprine, cyclosporine A, mycophenolate mofetil) and eltrombopag.
Exclusion
- Other autoimmune systemic diseases other than ITP.
- Multi-lineage immune cytopenias, such as Evan's syndrome, autoimmune pancytopenia.
- Secondary ITP.
- Received a vaccine within 4 weeks prior to the first dose of the study drug or planned during the study.
- Use of anticoagulants or any agents that have antiplatelet effect or can affect thrombopoiesis within 3 weeks prior to the first dose of the study drug.
- Received blood transfusion within 1 week prior to the first dose of the study drug.
- Received the intravenous gamma globulin, anti-D immunoglobulin, or plasmapheresis within 2 weeks prior to the first dose of the study drug.
- Received high-dose dexamethasone or high-dose methylprednisolone within 2 weeks prior to the first dose of the study drug.
- Received recombinant human thrombopoietin (rhTPO) within 4 weeks prior to the first does of the study drug.
- Received rituximab or other non-rituximab anti-CD20 drugs within 6 months prior to the first does of the study drug.
- Treated with splenectomy within 4 weeks prior to first dose of the study drug.
- Any thromboembolic or embolic events within 12 months prior to the first does of the study drug.
- Serum total IgG \< 700 mg/dL at the screening visit.
Key Trial Info
Start Date :
July 21 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 11 2023
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04428255
Start Date
July 21 2020
End Date
March 11 2023
Last Update
February 10 2021
Active Locations (1)
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1
Hematology hospital, Chinese academy of medical sciences
Tianjin, Tianjin Municipality, China, 300020