MedTrace Logo

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

NCT04428255 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2026-04-28

No results posted yet for this study

Summary

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

Conditions

  • Primary Immune Thrombocytopenic Purpura

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

Sponsors & Collaborators

  • Harbour BioMed (Guangzhou) Co. Ltd.

    lead INDUSTRY

Principal Investigators

  • Renchi Yang · Hematology hospital, Chinese academy of medical sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-24
Primary Completion
2021-08-10
Completion
2021-08-11

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04428255 on ClinicalTrials.gov