EUCTR2017-004012-19-NO进行中（未招募）1 期
An Adaptive, Open-Label, Dose-Finding, Phase 1/2 Study Investigating the Safety, Pharmacokinetics, and Clinical Activity of PRN1008, an Oral BTK Inhibitor, in Patients with Relapsed Immune Thrombocytopenic Purpura
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Inclusion Criteria:
- •1. Male or female patients, aged 18 to 80 years old (Czech Republic only: 18 to 65 years old)
- •2. Immune-related ITP (both primary and secondary)
- •3. Refractory or relapsed patients with no available and approved therapeutic options with a platelet count of <30,000/µL on two occasions no less than 7 days apart in the 15 days prior to beginning study treatment.
- •4. A history of response (two or more platelet counts = 50,000 µL with an increase of at least 20,000 µL) to at least one prior line of therapy (with splenectomy being considered a line of therapy)
- •5. Adequate hematologic, hepatic, and renal function (absolute neutrophil count = 1.5 X 109/L, Hgb > 9 g/dL, AST/ALT = 1.5 x ULN, albumin = 3 g/dL, total bilirubin = 1.5 x ULN, estimated
- •GFR > 60 (Cockcroft and Gault method) (C1D1 pre dose may be checked up to Day -3 prior to C1D1)
- •6. Female patients who are of reproductive potential must agree for the duration of active treatment in the study to use a highly effective means of contraception (hormonal contraception methods that inhibits ovulation, intrauterine device, intrauterine hormone-releasing system, bilateral tubal ligation, vasectomized partner or true abstinence; when it is in line with the preferred and usual lifestyle or the patient). Unless surgically sterile, postmenopausal females should have menopause confirmed by FSH testing.
- •7. Able to provide written informed consent and agreeable to the schedule of assessments
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •1. Pregnant or lactating women
- •2. ECG findings of QTcF > 450 msec (males) or > 470 msec (females), poorly controlled atrial fibrillation (i.e., symptomatic patients or a ventricular rate above 100 beats/min on ECG), or other
- •clinically significant abnormalities
- •3. History of current, active malignancy requiring or likely to require chemotherapeutic or surgical treatment during the trial, with the exception of non-melanoma skin cancer
- •4. Transfusion with blood or blood products or plasmapheresis within 2 weeks before Day 1
- •5. Change in corticosteroid and/or TPO agonist dose within 2 weeks prior to Day 1 (more than 10% variation from Day 1 daily doses)
- •6. Use of rescue medications other than corticosteroids or TPO in exclusion #5 in the two weeks before Day 1
- •7. Immunosuppressant drugs other than corticosteroids – these drugs should be discontinued for at least 14 days before Day 1
- •8. Treatment with rituximab or splenectomy within the 3 months prior to Day 1
- •9. Ongoing need for the use of proton pump inhibitor drugs such as omeprazole and esomeprazole (it is acceptable to change patient to H2 receptor blocking drugs prior to Day 1)
- •10. Concomitant use of known strong-to-moderate inducers or inhibitors of CYP3A within 3 days or 5 half-lives (whichever is longer) of Day 1
- •11. Use of CYP3A-sensitive substrate drugs with a narrow therapeutic index within 3 days or 5 half-lives (whichever is longer) of study drug dosing including, but not limited to, alfentanil, astemizole, cisapride, cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, tacrolimus, or terfenadine
- •12. Planned or concomitant use of any anticoagulants and platelet aggregation inhibiting drugs such as aspirin, NSAIDs, thienopyridenes (within 14 days of planned dosing through end of
- •follow-up), fish oil supplements (within 30 days of planned dosing through end of follow-up)
- •13. Has received any investigational drug within the 30 days before receiving the first dose of study medication, or at least 5 times elimination half-life of the drug (whichever is longer); patient
- •should not be using an investigational device at the time of dosing
- •14. Current drug or alcohol abuse
- •15. Refractory nausea and vomiting, malabsorption, external biliary shunt, or significant bowel resection that would preclude adequate study drug absorption
- •16. History of solid organ transplant
- •17. Positive for screening for HIV, hepatitis B (surface and core antibodies unrelated to vaccination), or hepatitis C (anti-HCV antibody confirmed with Hep C RNA)
- •18. History of serious infections requiring intravenous therapy within the last 3 months before Day 1
- •19. Clinically significant cognitive dysfunction (= Grade 1) or medical history suggestive of increased risk for cognitive dysfunction during the study
- •20. Live vaccine within 28 days prior to Day 1 or plan to receive one during the study
- •21. Planned surgery in the time frame of the dosing period
- •22. Any other clinically significant disease, condition, or medical history that, in the opinion of the Investigator, would interfere with subject safety, study evaluations, and/or study procedures
研究者
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