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NCT Number: NCT06686927

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

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.

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Key information

Conditions

Primary Immune Thrombocytopenia Autoimmune Diseases Blood Coagulation Disorders Blood Platelet Disorders Cytopenia Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Hemorrhagic Disorders Immune System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Purpura Purpura, Thrombocytopenic Purpura, Thrombocytopenic, Idiopathic Signs and Symptoms Skin Manifestations Thrombocytopenia Thrombotic Microangiopathies

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants must sign a written informed consent prior to enrollment;
  • Ages 18-75;
  • Platelet count <10×10^9/L with active bleeding or bleeding score ≥5;
  • No contraindications to the use of steroids, romiplostim, or IVIG, and willingness to receive these treatments;
  • No prior splenectomy or at least one first-line ITP treatment or emergency treatment;
  • No prior romiplostim treatment;
  • ECOG PS score: 0-2;
  • Female participants of childbearing potential must agree to use reliable contraception (including male or female condoms, contraceptive foam, contraceptive jelly, contraceptive patches, contraceptive cream, contraceptive suppositories, abstinence, and placement of intrauterine contraceptive devices) throughout the study; women who have had a hysterectomy, bilateral oophorectomy, bilateral salpingo-oophorectomy, or have been postmenopausal for more than 1 year, and men who have had bilateral vasectomy or vasectomy are excluded;
  • Voluntary participation in this study and good compliance.

Exclusion criteria

  • Individuals with the following hematological disorders other than ITP, including but not limited to leukemia, thrombocytopenia caused by cancer treatment, myeloproliferative diseases, multiple myeloma, and myelodysplastic syndrome;
  • Individuals with a history of thrombosis;
  • Pregnant or lactating individuals;
  • Individuals with severe cardiopulmonary insufficiency;
  • Individuals with severe or uncontrollable infections;
  • Individuals with viral infections;
  • Individuals who cannot comply due to psychological reasons;
  • Individuals who are deemed unsuitable for participation in the study by the investigator.

Treatment and study plan

corticosteroids combined with immunoglobulin and romiplostim

Drug

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.

Primary outcomes

  1. The total effective rate of treatment for 30 days

    Time frame: one months

    GR = CR + R (Complete reaction CR, platelet count ≥ 100×10^9/L, and no bleeding symptoms; Effective R, platelet count between 30×10^9/L and 100×10^9/L, and at least double the baseline value, and no bleeding symptoms)

Secondary outcomes

  1. Early (week) response rate R

    Time frame: one months

    Effective R, platelet count between 30×10^9/L and 100×10^9/L, and at least double the baseline value, and no bleeding symptoms

  2. Early Complete Response Rate (CR)

    Time frame: one months

    Complete reaction CR, platelet count ≥ 100×10^9/L, and no bleeding symptoms

  3. Time to Reaction

    Time frame: one months

    Time of Starting Treatment Until Platelet Count ≥ 30×10^9/L

  4. Adverse events during treatment

    Time frame: four months

    evaluated using Version 5.0 of the "Common Terminology Criteria for Adverse Events(NCI CTC AE)"

Study contacts

Contact information is provided by the study sponsor or research team.

Liang Tang

CONTACT

[email protected]

13554153411

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Institute of Hematology & Blood Diseases Hospital, China
  • Qilu Hospital of Shandong University
  • The First Affiliated Hospital of Soochow University

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 13, 2024
Registry last updated
Jan 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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