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).
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;
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;
Parallel
Avatrombopag+All trans retinoic acid
DrugAvatrombopag, po, starting dose 20mg qd, later adjusted dose or frequency according to response; All trans retinoic acid, po, 10mg bid.
Avatrombopag
DrugAvatrombopag, po, starting dose 20mg qd, later adjusted dose or frequency according to response
Treatment Free Rate at week 52
At weeks 12 and 24 without rescue treatment, the proportion of subjects with platelet levels reaching CR, R, and ≥ 50 × 10^9/L, respectively
Treatment Free Rate at week 12 after discontinuation of treatment
The proportion of subjects whose platelet levels reached CR and R at 12 weeks after discontinuation of treatment
The time from the start of treatment to the first platelet count ≥ 50 × 10^9/L
From date of randomization until the date of first documented platelet count ≥ 50 × 10\^9/L, assessed up to 52 weeks
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This trial is not recruiting at the moment. You can still explore other options:
