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

PHASE2RecruitingINTERVENTIONAL
Enrollment

129

Participants

Timeline

Start Date

May 22, 2025

Primary Completion Date

January 31, 2028

Study Completion Date

August 31, 2028

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.

Trial Locations (1)

300020

RECRUITING

Chinese Academy of Medical Science and Blood Disease Hospital, Tianjin

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Weifang People's Hospital

OTHER

collaborator

Shenzhen Second People's Hospital

OTHER

collaborator

The Affiliated Hospital of Qingdao University

OTHER

collaborator

The Affiliated Hospital of Nantong University

UNKNOWN

collaborator

The First Affiliated Hospital of Bengbu Medical University

OTHER

collaborator

The Second Affiliated Hospital of Dalian Medical University

OTHER

collaborator

Affiliated Hospital of North Sichuan Medical College

OTHER

collaborator

Changzhi Medical College

OTHER

collaborator

North China University of Science and Technology

OTHER

collaborator

Tianjin Hospital of ITCWM-Nankai Hospital

UNKNOWN

collaborator

Baoding First Central Hospital

OTHER

lead

Institute of Hematology & Blood Diseases Hospital, China

OTHER

NCT06992128 - Romiplostim N01 Combined With Glucocorticoids as the First-line Treatment for Newly Diagnosed Adult Primary Immune Thrombocytopenia: A Multicenter, Interventional Trial | Biotech Hunter | Biotech Hunter