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New treatment option for Immune Thrombocytopenia
Official title TPO-RA Treatment on Immune Tolerance Induction of ITP Patients With Sustained Platelet Recovery After Treatment Termination
ClinicalTrials.gov ID: NCT06478537
What this study is testing
What is Hetrombopag Olamine?
Hetrombopag Olamine is an investigational medicine, given as an once-daily, being studied as a potential treatment for immune thrombocytopenia.
Also referred to as Hetrombopag.
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
- The aim of this study was to observe whether maintaining a high level of platelet count after TPO-RA in patients with primary immune thrombocytopenia (ITP) can induce immune tolerance, develop immune balance in ITP patients, and enable patients to achieve a sustained response (SRoT) after TPO-RA discontinuation.
- 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 18 to 50
You may be able to join if
- Age ≥18 years old, regardless of gender;
- Patients with newly diagnosed or persistent primary ITP who have shown inadequate response or relapse following first-line corticosteroid treatment...
- Complete response (PLT \> 100 × 10\^9/L) achieved after hetrombopag treatment at doses of 2.5mg-7.5mg per day;
- Volunteer to participate in clinical research and sign an informed consent form, willing to follow and capable of completing all trial procedures.
You likely can't join if
- Age\>50 years old;
- Those who are contraindicated to taking aspirin;
- Previous arterial or venous thrombosis history (including coronary atherosclerotic heart disease, ischemic stroke, deep vein thrombosis or pulmonary...
- Risk factors of cardiovascular diseases such as hypertension, diabetes and hyperlipidemia;
- Heart disease occurring within the first 3 months of screening, including congestive heart failure classified as III/IV by the New York Heart...
- Patients currently undergoing anticoagulant therapy or antiplatelet therapy;
See the full eligibility criteria
- Age ≥18 years old, regardless of gender;
- Patients with newly diagnosed or persistent primary ITP who have shown inadequate response or relapse following first-line corticosteroid treatment with or without IVIg;
- Complete response (PLT \> 100 × 10\^9/L) achieved after hetrombopag treatment at doses of 2.5mg-7.5mg per day;
- Volunteer to participate in clinical research and sign an informed consent form, willing to follow and capable of completing all trial procedures.
- Age\>50 years old;
- Those who are contraindicated to taking aspirin;
- Previous arterial or venous thrombosis history (including coronary atherosclerotic heart disease, ischemic stroke, deep vein thrombosis or pulmonary embolism, etc.) or clinical symptoms and medical history indicate...
- Risk factors of cardiovascular diseases such as hypertension, diabetes and hyperlipidemia;
- Heart disease occurring within the first 3 months of screening, including congestive heart failure classified as III/IV by the New York Heart Association (NHYA), arrhythmias or myocardial infarction requiring...
- Patients currently undergoing anticoagulant therapy or antiplatelet therapy;
- Female patients receiving estrogen replacement therapy or oral contraceptives;
- Patients with past or current malignant tumors;
- Secondary thrombocytopenia, such as myelodysplastic syndrome, immune disorders such as systemic lupus erythematosus, early aplastic anemia, atypical aplastic anemia, antiphospholipid syndrome, thrombotic...
- The results of bone marrow biopsy during the screening period indicate that the bone marrow fibrosis MF is ≥ 2 (Thieleja 2005, the European expert consensus bone marrow fibrosis scoring standard), or that bone marrow...
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) are three times higher than the upper limit of normal values, total bilirubin is three times higher than the upper limit of normal values, and blood...
- Have a history of liver cirrhosis or portal hypertension;
- Uncontrollable infections;
- Hepatitis B surface antigen positive or previous history of hepatitis B, and in the past 3 months, accompanied by HBV-DNA ≥ 2000IU/ML; those with positive hepatitis C antibody, HCV-RNA positive in the past 3 months;
- Individuals who test positive for antibodies against human immunodeficiency virus or specific antibodies against Treponema pallidum;
- Individuals who are known to be allergic to the drug itself or its excipients;
- Breastfeeding or pregnant women or female patients planning to conceive during the study period; 18）Other situations determined by the researcher as unsuitable for participation in this study
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, 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 50 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, 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.