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Tests treatment safety and results for Relapsed/Refractory Immune Thrombocytopenia
Official title The Investigate Efficacy and Safety Evaluation of Bortezomib in Patients With Relapsed/Refractory Immune Thrombocytopenia
ClinicalTrials.gov ID: NCT05599880
What this study is testing
What is Bortezomib?
Bortezomib is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for relapsed/refractory immune thrombocytopenia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- to investigate efficacy and safety evaluation of bortezomib in patients with relapsed/refractory immune thrombocytopenia
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 and older
You may be able to join if
- Men and women 19 years of age and older
- Patients diagnosed with immune thrombocytopenia (primary or secondary)
- (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...
- platelets \<30 x 109/L
- Patients in need of clinical treatment.
You likely can't join if
- pregnant, lactating women
- Patients allergic to bortezomib.
- Patients with Grade 2 or higher peripheral neuropathy requiring drug treatment.
- Patients with severe or uncontrolled active infection.
- Patients with significant immunoglobulin degradation in the immunoglobulin profile.
- HBV, HCV carrier or HIV patient. (However, if the patient is being stably maintained with antiviral treatment, and the expert opinion determines that...
See the full eligibility criteria
- Men and women 19 years of age and older
- Patients diagnosed with immune thrombocytopenia (primary or secondary)
- (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...
- platelets \<30 x 109/L
- Patients in need of clinical treatment.
- 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)...
- Patients who have been relapsed or refractory after receiving at least 2 treatments with a mechanism other than corticosteroids.
- 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
- Female patients of childbearing potential should have a negative urine or serum pregnancy test within 28 days before starting administration of the test drug.
- Patients who voluntarily or legal guardians have given written consent to participate in this clinical trial.
- pregnant, lactating women
- Patients allergic to bortezomib.
- Patients with Grade 2 or higher peripheral neuropathy requiring drug treatment.
- Patients with severe or uncontrolled active infection.
- Patients with significant immunoglobulin degradation in the immunoglobulin profile.
- 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...
- Patients currently undergoing chemotherapy.
- 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...
- 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...
- Patients currently participating in other clinical trials.
- Patients who are not considered suitable for participation in clinical trials in the opinion of the researcher.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Guri-si, South Korea
- Seoul, South Korea
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guri-si, South Korea; Seoul, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.