Romiplostim N01 Combined With Glucocorticoids as the First-line Treatment for Newly Diagnosed Adult Primary Immune Thrombocytopenia: A Multicenter, Interventional Trial

Summary

This prospective, multicenter, randomized study aim to evaluate the efficacy and safety of romiplostim N01 combined with glucocorticoids as the first-line treatment for newly diagnosed adult primary immune thrombocytopenia (ITP).

Conditions

• Primary Immune Thrombocytopenia (ITP)

Interventions

DRUG

Romiplostim N01 combined with dexamethasone

Dexamethasone (HD-DXM) at a dose of 40mg/d for 4 days constitutes one cycle. If there is no response on the 10th day, repeat it once. The administration can be either oral or intravenous. Meanwhile, romiplostim N01 is administered with an initial dose of 3µg/kg by subcutaneous injection within 4 days of dexamethasone treatment once a week for up to 6 months.

DRUG

Dexamethasone monotherapy

Dexamethasone (HD-DXM) 40mg/d × 4 days, one cycle. If there is no response on the 10th day, repeat once, administered either orally or intravenously.

Sponsors & Collaborators

• Weifang People's Hospital

  collaborator OTHER

• Shenzhen Second People's Hospital

  collaborator OTHER

• The Affiliated Hospital of Qingdao University

  collaborator OTHER

• The Affiliated Hospital of Nantong University

  collaborator UNKNOWN

• The First Affiliated Hospital of Bengbu Medical University

  collaborator OTHER

• The Second Affiliated Hospital of Dalian Medical University

  collaborator OTHER

• Affiliated Hospital of North Sichuan Medical College

  collaborator OTHER

• Changzhi Medical College

  collaborator OTHER

• North China University of Science and Technology

  collaborator OTHER

• Tianjin Hospital of ITCWM-Nankai Hospital

  collaborator UNKNOWN

• Baoding First Central Hospital

  collaborator OTHER

• Institute of Hematology & Blood Diseases Hospital, China

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-05-22

Primary Completion

2028-01-31

Completion

2028-08-31

Countries

• China

Study Locations