Avatrombopag Combined With All-trans Retinoic Acid in the Treatment of Primary Immune Thrombocyto… (NCT07278908) | Clinical Trial Compass
Not Yet RecruitingPhase 2/3
Avatrombopag Combined With All-trans Retinoic Acid in the Treatment of Primary Immune Thrombocytopenia
248 participantsStarted 2025-12
Plain-language summary
This study is an open label, randomized controlled, multicenter clinical trial aimed at comparing the efficacy and safety of the combination of atorvastatin and all trans retinoic acid with atorvastatin alone in the treatment of first-line ineffective or recurrent immune thrombocytopenia.
The study is divided into a screening period (2 weeks), a treatment period (0-24 weeks), a reduction period (25-36 weeks), and a follow-up period (37-52 weeks), with a total of one year from the start of treatment to the end of follow-up (52 weeks).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. The patient signs an informed consent form;
✓. ≥ 18 years old;
✓. The patient's history of ITP is at least 3 months (persistent or chronic ITP);
✓. The platelet count of the subject within 24 hours before the first administration of the study drug is less than 30 × 10\^9/L; during the screening period, platelet count is measured at least twice (at least 1 week apart), with an average platelet count of less than 30 × 10\^9/L and no platelet count greater than 35 × 10\^9/L;
✓. First line treatment, such as ineffective hormone or immunoglobulin therapy, or ITP patients who relapse after treatment;
✓. Receive concomitant therapy drugs (including stable doses of glucocorticoids within the past month, stable doses of azathioprine, danazol, cyclosporine A, or mycophenolate mofetil within the past three months) for treatment; TPO receptor agonists should be discontinued at least 2 weeks before enrollment; Patients receiving anti-CD20 treatment should discontinue the medication six months prior to enrollment; Patients who underwent splenectomy were enrolled six months after the completion of the surgery;
✓. Within the past year, there have been no heart diseases, including NYHA class III/IV congestive heart failure, drug-induced arrhythmias, or myocardial infarction;
✓. Laboratory tests of coagulation function showed that the prothrombin time (PT/INR) and activated partial thromboplastin time (APTT) values did not exceed 20% of the normal reference range; No history of coagulation abnormalities except for ITP;
Exclusion criteria
What they're measuring
1
Treatment Free Rate at week 52
Timeframe: up to 52 weeks
Trial details
NCT IDNCT07278908
SponsorInstitute of Hematology & Blood Diseases Hospital, China
. Individuals who are allergic to known ingredients or excipients in atorvastatin or all trans retinoic acid;
✕. Accept medication maintenance therapy (including but not limited to aspirin, clopidogrel, and/or nonsteroidal anti-inflammatory drugs NSAIDs) or anticoagulants that affect platelet function or quantity;
✕. Accompanied by autoimmune hemolytic anemia, or various secondary or hereditary thrombocytopenia; Such as leukemia, lymphoma, multiple myeloma, aplastic anemia, myelodysplastic syndrome, Evans syndrome, common variant immunodeficiency, systemic lupus erythematosus, cirrhosis, antiphospholipid antibody syndrome, pseudothrombocytopenia, drug-induced thrombocytopenia (such as quinine, heparin, antimicrobial drugs, antiepileptic drugs, etc.), etc;
✕. There is bone marrow fibrosis with MF ≥ 2;
✕. Participate in other research drug studies (including vaccine studies) or be exposed to other research drugs (TPO receptor agonists or salvage treatments) within 4 weeks or 5 half lives (whichever is longer) before the first use of the medication;
✕. Previous ITP treatments, including rescue therapy with platelet transfusions, glucocorticoids, immunoglobulins, immunomodulators, etc., did not end within 2 weeks prior to enrollment;
✕. The subject has a history of any arterial/venous thrombosis (including stroke, transient ischemic attack, myocardial infarction, deep vein thrombosis, or pulmonary embolism) within the past year;