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COMPLETED
NCT04428255
PHASE2/PHASE3

A Clinical Study on the Efficacy and Safety of HBM9161 in Patients With ITP

Sponsor: Harbour BioMed (Guangzhou) Co. Ltd.

View on ClinicalTrials.gov

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

Interventions

DRUG

HBM9161 Dose A

HBM9161 (Dose A or Dose B) or matching placebo will be administered IV weekly

DRUG

HBM9161 Dose B

HBM9161 (Dose A or Dose B) or matching placebo will be administered IV weekly

DRUG

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