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Compares treatment options for Primary Immune Thrombocytopenia (ITP)
Official title High-Dose Dexamethasone Combined With Orelabrutinib Versus High-Dose Dexamethasone Combined With Placebo in Adult Patients With Newly Diagnosed Primary Immune Thrombocytopenia
ClinicalTrials.gov ID: NCT07559331
What this study is testing
What is High-Dose Dexamethasone Combined with Orelabrutinib?
High-Dose Dexamethasone Combined with Orelabrutinib is an investigational medicine, given as an once-daily, being studied as a potential treatment for primary immune thrombocytopenia (itp).
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
- This is a randomized controlled study of high-dose Dexamethasone combined with Orelabrutinib versus high-dose Dexamethasone combined with placebo in adult patients with newly diagnosed Primary Immune Thrombocytopenia.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- people must thoroughly understand the nature, significance, potential benefits, possible inconveniences, and potential risks of the trial prior to...
- Male or female people aged 18-80 years (inclusive).
- Body weight ≥35 kg at screening.
- Adult patients with newly diagnosed, untreated primary ITP, with platelet count (PLT) \<30×10⁹/L and no active bleeding in vital organs.
- people who responded to prior treatment with oral dexamethasone 40 mg/day for 4 days, defined as meeting all three of the following criteria on any...
You likely can't join if
- people with severe ITP at screening (e.g., life-threatening thrombocytopenia, major bleeding events, or requiring urgent treatment including...
- people with autoimmune systemic diseases other than ITP, unless the investigator determines that such conditions will not affect the evaluation of...
- people who failed to respond to prior treatment with oral dexamethasone 40 mg/day for 4 days, defined as meeting any of the following criteria on any...
- History of intracranial hemorrhage within 6 months prior to screening.
- people with a history of coagulation disorders other than ITP, such as disseminated intravascular coagulation, hemolytic uremic syndrome, or...
- people with a known hypersensitivity to any component of the study drugs described in this protocol.
See the full eligibility criteria
- people must thoroughly understand the nature, significance, potential benefits, possible inconveniences, and potential risks of the trial prior to enrollment. They must understand the study procedures and voluntarily...
- Male or female people aged 18-80 years (inclusive).
- Body weight ≥35 kg at screening.
- Adult patients with newly diagnosed, untreated primary ITP, with platelet count (PLT) \<30×10⁹/L and no active bleeding in vital organs.
- people who responded to prior treatment with oral dexamethasone 40 mg/day for 4 days, defined as meeting all three of the following criteria on any day between Day 5 and Day 7 post-treatment: ① PLT ≥30×10⁹/L; ② ≥2-fold...
- Women of childbearing potential must use an effective method of contraception during the screening period, throughout the entire trial, and for 90 days following the last dose of study medication.
- people with severe ITP at screening (e.g., life-threatening thrombocytopenia, major bleeding events, or requiring urgent treatment including intravenous immunoglobulin, high-dose glucocorticoids, or plasma exchange)...
- people with autoimmune systemic diseases other than ITP, unless the investigator determines that such conditions will not affect the evaluation of study outcomes.
- people who failed to respond to prior treatment with oral dexamethasone 40 mg/day for 4 days, defined as meeting any of the following criteria on any day between Day 5 and Day 7 post-treatment: ① PLT \<30×10⁹/L; ②...
- History of intracranial hemorrhage within 6 months prior to screening.
- people with a history of coagulation disorders other than ITP, such as disseminated intravascular coagulation, hemolytic uremic syndrome, or thrombotic thrombocytopenic purpura.
- people with a known hypersensitivity to any component of the study drugs described in this protocol.
- Known human immunodeficiency virus (HIV) infection, or positive serologic test results.
- people with positive tuberculosis screening test (based on interferon-gamma release assay, including T-SPOT®, etc.), or active, latent, or incompletely appropriately treated tuberculosis at screening.
- Activated partial thromboplastin time (aPTT) ≥1.5× upper limit of normal (ULN) or international normalized ratio (INR) ≥1.5 at screening.
- Organ dysfunction, with the following laboratory findings at screening: Absolute neutrophil count (ANC) \ 1.2×ULN; aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>ULN. Amylase or lipase \>2×ULN...
- Pregnant or lactating women.
- people unable to undergo blood collection, or with contraindications to phlebotomy.
- Any other condition that the investigator considers unsuitable for participation in this trial.
The study team makes the final eligibility decision.
Where it's taking place
- Jinan, Shandong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jinan, Shandong, China. 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.