NCT05599880 The Investigate Efficacy and Safety Evaluation of Bortezomib in Patients With Relapsed/Refractory Immune Thrombocytopenia
| NCT ID | NCT05599880 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Seoul National University Hospital |
| Condition | Relapsed/Refractory Immune Thrombocytopenia |
| Study Type | INTERVENTIONAL |
| Enrollment | 29 participants |
| Start Date | 2023-07-07 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 29 participants in total. It began in 2023-07-07 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
to investigate efficacy and safety evaluation of bortezomib in patients with relapsed/refractory immune thrombocytopenia
Eligibility Criteria
Inclusion Criteria: 1. Men and women 19 years of age and older 2. Patients diagnosed with immune thrombocytopenia (primary or secondary) 3. (Patients with at least one of B, C, or D meeting A below.) A.A person who has been confirmed not to be due to a cause of decreased platelet production in the bone marrow in the results of bone marrow examination within the past 5 years. (Bone marrow examination is required if there is no bone marrow examination result within the last 5 years.) B.After being diagnosed with ITP, there has been a case of complete platelet response with plt \>100k in immunoglobulin therapy. C.Patients suspected of having primary immune thrombocytopenia with proven anti-platelet antibody., D.Helicobacter IgG, antinuclear antibody (ANA), anticardiolipin antibody (ACA), nonspecific inhibitor (NSI), etc. have been proven, and secondary immune thrombocytopenia caused by autoimmune disease is suspected. 4. platelets \<30 x 109/L 5. Patients in need of clinical treatment. 6. Patients who have relapsed or refractory after receiving treatment with corticosteroids (prednisolone cumulative dose 5.6mg/kg (0.8mg/kg 1 week) or more or dexamethasone cumulative dose 80mg (20mg 4 days) or more)., However, there are exceptions when corticosteroids are contraindicated. 7. Patients who have been relapsed or refractory after receiving at least 2 treatments with a mechanism other than corticosteroids. 8. Patients who underwent two different treatments from among the treatment methods below. * Splenectomy * eltrombopag or romiplostim * Rituximab treatment * Azathioprine * cyclosporine or mycophenolate mofetil(MMF) * vincristine or cyclophosphamide * danazol * dapsone * Alemtuzumab 9. Female patients of childbearing potential should have a negative urine or serum pregnancy test within 28 days before starting administration of the test drug. 10. Patients who voluntarily or legal guardians have given written consent to participate in this clinical trial. Exclusion Criteria: 1. pregnant, lactating women 2. Patients allergic to bortezomib. 3. Patients with Grade 2 or higher peripheral neuropathy requiring drug treatment. 4. Patients with severe or uncontrolled active infection. 5. Patients with significant immunoglobulin degradation in the immunoglobulin profile. 6. HBV, HCV carrier or HIV patient. (However, if the patient is being stably maintained with antiviral treatment, and the expert opinion determines that it is possible to participate in the clinical trial along with antiviral treatment and prevention, participation is possible.) 7. Patients currently undergoing chemotherapy. 8. Patients whose bone marrow did not recover after cancer treatment, or whose cause other than immune destruction was confirmed by bone marrow examination, such as thrombocytopenia due to intramedullary abnormalities. However, if the presence of anti-platelet antibodies is proven and thrombocytopenia due to immune destruction is strongly suspected clinically, registration is possible even if there are other causes of thrombocytopenia.) 9. Patients who may become pregnant. However, women of childbearing age(If postmenopausal women are not of childbearing age, they must have been menstruating for at least 12 months.) who have not undergone sterilization can participate in the clinical trial only if the pregnancy test is negative. And, effective contraception must be maintained throughout the entire trial period. 10. Patients currently participating in other clinical trials. 11. Patients who are not considered suitable for participation in clinical trials in the opinion of the researcher. 12. Patients with inadequate organ function. * total bilirubin \> 3 x ULN * creatinine \> 1.5 x ULN * liver function test AST(SGOT) \& ALT(SGPT) \> 3 x ULN
Contact & Investigator
Dong-Yeop Shin, MD, PhD
STUDY CHAIR
Seoul National University Hospital
Frequently Asked Questions
Who can join the NCT05599880 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Relapsed/Refractory Immune Thrombocytopenia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05599880 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05599880 currently recruiting?
Yes, NCT05599880 is actively recruiting participants. Contact the research team at stephano.dyshin@gmail.com for enrollment information.
Where is the NCT05599880 trial being conducted?
This trial is being conducted at Guri-si, South Korea, Seoul, South Korea, Seoul, South Korea, Seoul, South Korea.
Who is sponsoring the NCT05599880 clinical trial?
NCT05599880 is sponsored by Seoul National University Hospital. The principal investigator is Dong-Yeop Shin, MD, PhD at Seoul National University Hospital. The trial plans to enroll 29 participants.