Treatment for severe primary immune thrombocytopenia using a combination of medications

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

This study is testing a new combination of medications to see if it can help adults with severe immune thrombocytopenia who have low platelet counts and are experiencing bleeding.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology (Academic / other)
• Drugs / interventions: Prednisone
• Locations: 1 site (Wuhan, Hubei)
• Trial ID: NCT06686927 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness and safety of a combination treatment involving glucocorticoids, gamma globulin, and romiplostim N01 for adults with severe primary immune thrombocytopenia (ITP). Participants will receive romiplostim via subcutaneous injection, IVIG through intravenous administration, and prednisone orally or intravenously over a one-month period. The study focuses on patients with a platelet count below 10×10^9/L and active bleeding or a significant bleeding score. The primary goal is to determine how well this combination therapy works during the initial treatment phase.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with severe primary immune thrombocytopenia and active bleeding.

Not a fit: Patients who have previously received romiplostim treatment or have undergone splenectomy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve platelet counts and reduce bleeding risks in patients with severe ITP.

How similar studies have performed: While there have been studies on individual components of this treatment, the specific combination approach is novel and has not been extensively tested.

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.

Where this trial is running

Wuhan, Hubei

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)

Study contacts

• Study coordinator: Liang Tang

Conditions Primary Immune Thrombocytopenia; severe ITP; Romiplostim