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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04428255
Other study ID # 9161.4
Secondary ID
Status Recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date July 21, 2020
Est. completion date March 11, 2023

Study information

Verified date February 2021
Source Harbour BioMed (Guangzhou) Co. Ltd.
Contact Shuai Zhao
Phone +86 15901236575
Email peter.zhao@harbourbiomed.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To select a dose and to make a decision for Phase 3 study


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 monoclonal antibody that can effectively remove pathogenic IgG, thereby relieving platelet destruction and rapidly increasing platelet counts in patients. The study will be conducted in a Phase 2/3 operational seamless design, with group Dose A and Dose B of HBM9161 and a placebo group in Phase 2.


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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
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

Country Name City State
China Hematology hospital, Chinese academy of medical sciences Tianjin Tianjin

Sponsors (1)

Lead Sponsor Collaborator
Harbour BioMed (Guangzhou) Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of patients who achieve the early response. The primary endpoint of phase 2 7 weeks
Secondary Proportion of patients who achieve platelet count = 50 × 10^9/L at least 2 times within 7 weeks. 7 weeks
See also
  Status Clinical Trial Phase
Recruiting NCT04890041 - TPO-RA in Primary Immune Thrombocytopenia (ITP) in Patients Older Than 14 Years N/A