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

PHASE2RecruitingINTERVENTIONAL
Enrollment

129

Participants

Timeline

Start Date

June 1, 2024

Primary Completion Date

June 30, 2025

Study Completion Date

August 30, 2026

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.

Trial Locations (1)

300000

RECRUITING

Chinese Academy of Medical Science and Blood Disease Hospital, Tianjin

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

The Second Affiliated Hospital of Kunming Medical University

OTHER

collaborator

Weifang People's Hospital

OTHER

collaborator

Shenzhen Second People's Hospital

OTHER

collaborator

The Affiliated Hospital of Qingdao University

OTHER

collaborator

Changzhi Medical College

OTHER

collaborator

Affiliated Hospital of Nantong University

OTHER

collaborator

The First People's Hospital of Yunnan

OTHER

collaborator

The First Affiliated Hospital of Bengbu Medical University

OTHER

collaborator

Suining Central Hospital

OTHER

collaborator

The Second Affiliated Hospital of Dalian Medical University

OTHER

collaborator

North China University of Science and Technology

OTHER

collaborator

Guizhou Provincial People's Hospital

OTHER

lead

Institute of Hematology & Blood Diseases Hospital, China

OTHER

NCT06658834 - A Study of Romiplostim N01 as the First-line Treatment for Newly Diagnosed Adult Patients With ITP | Biotech Hunter | Biotech Hunter