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

NCT ID: NCT06686927

Last Updated: 2025-01-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-20
• Study Completion Date: 2025-12-20

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

corticosteroids combined with immunoglobulin and romiplostim

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Participants must sign a written informed consent prior to enrollment;

2. Ages 18-75;

3. Platelet count <10×10^9/L with active bleeding or bleeding score ≥5;

4. No contraindications to the use of steroids, romiplostim, or IVIG, and willingness to receive these treatments;

5. No prior splenectomy or at least one first-line ITP treatment or emergency treatment;

6. No prior romiplostim treatment;

7. ECOG PS score: 0-2;

8. 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;

9. Voluntary participation in this study and good compliance.

Exclusion Criteria

1. 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;

2. Individuals with a history of thrombosis;

3. Pregnant or lactating individuals;

4. Individuals with severe cardiopulmonary insufficiency;

5. Individuals with severe or uncontrollable infections;

6. Individuals with viral infections;

7. Individuals who cannot comply due to psychological reasons;

8. Individuals who are deemed unsuitable for participation in the study by the investigator.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qilu Hospital of Shandong University

OTHER

Sponsor Role: collaborator

Institute of Hematology & Blood Diseases Hospital, China

OTHER

Sponsor Role: collaborator

The First Affiliated Hospital of Soochow University

OTHER

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Wuhan, Hubei, China

Site Status: RECRUITING

Countries

China

Central Contacts

Liang Tang

Role: CONTACT

lancet.tang@qq.com

13554153411

Facility Contacts

Yu Hu, MD

Role: primary

dr_huyu387@163.com

027-85726114

Liang Tang

Role: backup

lancet.tang@qq.com

13554153411

Other Identifiers

2024-0503

Identifier Type: -

Identifier Source: org_study_id