A Study of Romiplostim N01 as the First-line Treatment for Newly Diagnosed Adult Patients With ITP

Summary

This study is a multicenter interventional research on the first-line treatment of newly diagnosed adult patients with immune thrombocytopenia (ITP) using romiplostim N01 in combination with glucocorticoids. The primary endpoint of this study is to assess the efficacy of romiplostim N01 combined with glucocorticoids in untreated newly diagnosed adult ITP patients after 6 months of administration.

The subjects will be divided into the experimental group and the control group for treatment.

Experimental group: 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. Simultaneously, romiplostim N01 is administered at an initial dose of 3µg/kg, by subcutaneous injection, once a week, for a maximum of 6 months.

Control group: 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.

Conditions

• Primary Immune Thrombocytopenia

Interventions

DRUG

Dexamethasone Combined with romiplostim N01

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 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

• The Second Affiliated Hospital of Kunming Medical University

  collaborator OTHER

• Weifang People's Hospital

  collaborator OTHER

• Shenzhen Second People's Hospital

  collaborator OTHER

• The Affiliated Hospital of Qingdao University

  collaborator OTHER

• Changzhi Medical College

  collaborator OTHER

• Affiliated Hospital of Nantong University

  collaborator OTHER

• The First People's Hospital of Yunnan

  collaborator OTHER

• The First Affiliated Hospital of Bengbu Medical University

  collaborator OTHER

• Suining Central Hospital

  collaborator OTHER

• The Second Affiliated Hospital of Dalian Medical University

  collaborator OTHER

• North China University of Science and Technology

  collaborator OTHER

• Guizhou Provincial People's 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

2024-06-01

Primary Completion

2025-06-30

Completion

2026-08-30

Countries

• China

Study Locations