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A Clinical Study on the Efficacy and Safety of HBM9161 in Patients With ITP
Sponsor: Harbour BioMed (Guangzhou) Co. Ltd.
Summary
To select a dose and to make a decision for Phase 3 study
Official title: A Randomized, Double-blind, Placebo-controlled, Phase 2/3 Operational Seamless Designed Clinical Study to Evaluate the Efficacy and Safety of HBM9161 Weekly Subcutaneous Injection in Patients With Primary Immune Thrombocytopenia
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
36
Start Date
2020-07-24
Completion Date
2021-08-11
Last Updated
2026-04-28
Healthy Volunteers
No
Conditions
Interventions
HBM9161 Dose A
HBM9161 (Dose A or Dose B) or matching placebo will be administered IV weekly
HBM9161 Dose B
HBM9161 (Dose A or Dose B) or matching placebo will be administered IV weekly
Placebo
HBM9161 (Dose A or Dose B) or matching placebo will be administered IV weekly
Locations (1)
Hematology hospital, Chinese academy of medical sciences
Tianjin, Tianjin Municipality, China