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Study on Glucocorticoid Combined With Gamma Globulin and Ropristine N01 in Treatment of Initial Severe ITP

NCT06686927 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2025-01-22

No results posted yet for this study

Summary

The goal of this clinical trial is to learn if romiplostim N01 works to treat severe primary immune thrombocytopenia in adults. It will also learn about the safety of romiplostim N01. The main question it aims to answer is:

TO evaluate the effectiveness of the combination treatment of glucocorticoids, gamma globulin and romiplostim N01 in patients with severe primary immune thrombocytopenia during the initial treatment period for one month.

Participants will:

Romiplostim N01, starting dose of 1 µg/kg, subcutaneous injection, given on the third day of IVIG, once a week, for up to one month.

IVIG, 400mg/kg/d, intravenous administration, continuous administration for 3-5 days.

Prednisone, 0.8mg/kg/d, taken orally or intravenously, for up to one month.

Conditions

  • Primary Immune Thrombocytopenia

Interventions

DRUG

corticosteroids combined with immunoglobulin and romiplostim

Romiplostim N01, starting dose of 1 µg/kg, subcutaneous injection, given on the third day of IVIG, once a week, for up to one month. IVIG, 400mg/kg/d, intravenous administration, continuous administration for 3-5 days. Prednisone, 0.8mg/kg/d, taken orally or intravenously, for up to one month.

Sponsors & Collaborators

  • Qilu Hospital of Shandong University

    collaborator OTHER

  • Institute of Hematology & Blood Diseases Hospital, China

    collaborator OTHER

  • The First Affiliated Hospital of Soochow University

    collaborator OTHER

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-20
Primary Completion
2025-09-20
Completion
2025-12-20

Countries

  • China

Study Locations

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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 NCT06686927 on ClinicalTrials.gov