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

NCT06686927 | Recruiting Phase 2 DMC

• 1 other identifier: 2024-0503
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

severe ITP; Romiplostim

Outcome Measures

Primary Outcomes (1)

• The total effective rate of treatment for 30 days

  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)

  one months

Secondary Outcomes (4)

• Early (week) response rate R

  one months

• Early Complete Response Rate (CR)

  one months

• Time to Reaction

  one months

• Adverse events during treatment

  four months

Study Arms (1)

Corticosteroids combined with immunoglobulin and romiplostim

EXPERIMENTAL

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.

Drug: corticosteroids combined with immunoglobulin and romiplostim

Interventions

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.

Corticosteroids combined with immunoglobulin and romiplostim

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead
• Qilu Hospital of Shandong University: collaborator
• Institute of Hematology & Blood Diseases Hospital, China: collaborator
• The First Affiliated Hospital of Soochow University: collaborator

Study Sites (1)

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

Wuhan, Hubei, 430000, China

RECRUITING

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Interventions

Immunoglobulins; romiplostim

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Liang Tang

CONTACT

13554153411; lancet.tang@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2024
• First Posted: November 13, 2024
• Study Start: November 20, 2024
• Primary Completion: September 20, 2025
• Study Completion: December 20, 2025
• Last Updated: January 22, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)