Lusutrombopag in the Treatment of Immune Thrombocytopenia (ITP) (NCT06287567) | Clinical Trial Compass
CompletedPhase 2
Lusutrombopag in the Treatment of Immune Thrombocytopenia (ITP)
China17 participantsStarted 2024-04-17
Plain-language summary
This exploratory study is to investigate the efficacy, safety and tolerability of Lusutrombopag in the treatment of primary immune thrombocytopenia in Chinese patients who have failed first-line therapy
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Males and females ≥18 years of age
✓. Subjects\>60 years must have had a diagnostic bone marrow aspiration in the last 3 years or responded to treatment (platelet count ≥50 x 10\^9/L)
✓. Participants diagnosed with primary persistent/chronic ITP (greater than or equal to 3 months duration) and an average of two platelet count less than 30 x 10\^9/L. Conditions which may cause thrombocytopenia other than ITP should be ruled out, including but not limited to systemic lupus erythematosus (SLE)，aplastic anemia (AA), and myelodysplastic syndromes (MDS)
✓. Relapsed persistent or chronic ITP status, with or without prior splenectomy. Participants who previously received one or more ITP therapies
✓. Subjects receiving rescue therapy (including but not limited to corticosteroids, immunoglobulins and immunosuppressant) must have completed these therapies for at least 1 week or failed within 1 week prior to dosing on the first day (Visit 1)
✓. Subjects receiving stable dosages of cyclosporine A, mycophenolate mofetil, azathioprine, or danazol are allowed, but must be receiving a dose that has been stable for at least 4 weeks prior to dosing on the first day (Visit 1)
✓. Subjects receiving Chinese herbal medicine must be stopped 1 weeks prior to dosing on the first day (Visit 1), and Chinese herbal medicine is not allowed during the study
✓. Subjects receiving steroid therapy must be on a stable dose for at least 2 weeks prior to screening (same milligram amount ± 10%； and ≤20 mg of equivalent dose of prednisone)
Exclusion criteria
✕
What they're measuring
1
Percentage of Participants with a Platelet Response after 4 Weeks
Timeframe: on Day 29 of Treatment
Trial details
NCT IDNCT06287567
SponsorInstitute of Hematology & Blood Diseases Hospital, China
. History of inherited or acquired, clinically important hemorrhagic clotting disorder
✕. Females who were pregnant or lactating, or receiving other hormone/chemical contraceptives
✕. Patients with potential fertility refused to take contraceptive methods
✕. Laboratory abnormalities
✕. Exposure to previous thrombopoietin (TPO) mimetics/agonists (e.g. romiplostim, recombinant human thrombopoietin (rhTPO), avatrombopag, eltrombopag and herombopag) within 4 weeks prior to initial screening.In addition, participants are allowed to be enrolled at the discretion of the investigator when platelet counts are below 30 x 10\^9/L within the 4 weeks after withdrawal of thrombopoietin (TPO) mimetics/agonists
✕. Subjects unresponsive to previous TPO mimetics/agonists
✕. Exposure to an investigative medication within 4 weeks prior to the initial Screening Visit or Use of the following drugs or treatment prior to Visit 1 (Day 1):
✕. History of clinically significant cardiovascular or thromboembolic disease within 26 weeks prior to Initial screening