EUCTR2018-003329-26-ES进行中（未招募）1 期
A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study to Evaluate the Efficacy and Safety of Oral SKI-O-703, SYK Inhibitor, in Patients with Persistent and Chronic Immune Thrombocytopenia (ITP)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Oscotec Inc.
- 入组人数
- 60
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
- •1. Able to provide written informed consent and agreeable to the schedule of assessments
- •2. Male or female subjects, aged 18 years or older
- •3. Diagnosis of primary ITP (persistent or chronic) made according to the American Society of Hematology 2011 evidence-based guideline
- •4. Failed to respond or relapsed after at least 1 prior therapy, with a platelet count of <30,000/µL on 2 occasions at least 7 days apart with the confirmatory count on the first day of treatment. Response to such prior therapy is defined as platelet count of =30,000/µL and >2 times increase from baseline in the absence of bleeding. Failure to respond and relapse to such prior therapy are defined as failure to achieve and/or failure to maintain response on a tolerable regiment of prior therapy.
- •5. Adequate hematologic, hepatic, and renal function (absolute neutrophil count = 1.5 X 109/L, hemoglobin [Hgb] = 10.0 g/dL, aspartate aminotransferase [AST] and alanine aminotransferase [ALT] = 2.0 x ULN, bilirubin <1.5 x ULN, albumin = 3 g/dL, estimated glomerular filtration rate [eGFR] =40 mL/min/1.73m2, and creatinine = 1.5 x ULN)
- •6. ECOG performance status of 0, 1, or 2
- •7. Female subjects must fulfil the following criteria:
- •a. Be of non-childbearing potential, defined as follows:
- •I. Postmenopausal (ie, = 1 year without any menses) prior to Screening, or
- •II. Documented surgically sterile (= 1 month prior to Screening)
- •b. Or if of childbearing potential:
- •I. Agree not to try to become pregnant during the study and for 90 days after the last dose
- •II. Have a negative pregnancy test at Screening, and
- •c. If heterosexually active, agree to consistently use 2 different forms of highly effective birth control (at least 1 of which must be a barrier method) starting at Screening and continuing throughout the study until after 90 days after the last dose. Highly effective forms of birth control include the following:
- •I. Consistent and correct use of established oral contraception
- •II. Established intrauterine device or intrauterine system
- •III. Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository
- •8. Female subjects must agree not to breastfeed starting from the time of Screening, throughout the study, and until after 90 days following the last dose.
- •9. Male subjects and their female spouse/partners who are of childbearing potential must use highly effective contraception methods consisting of 2 forms of birth control (at least 1 of which must be a barrier method) from the time of Screening, throughout the study, and until after 90 days following the last dose.
- •10. Male subjects must agree not to donate sperm starting from the time of Screening, throughout the study, and until after 90 days following the last dose of study drug
- •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 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •1. History of any clinically significant disease or disorder that in the opinion of the investigator or the sponsor may put the subject at risk due to study participation, impact the subject’s ability to participate in the study, or influence the study results
- •2. History of current, active malignancy requiring or likely to require chemotherapeutic or surgical treatment during the study, with the exception of non-melanoma skin cancer, carcinoma in situ of the cervix, and localized prostate cancer managed by active surveillance
- •3. Transfusion with blood or blood products or plasmapheresis within 2 weeks before the first administration of study drug (Day 1)
- •4. PT INR > 1.5
- •5. History of known inherited coagulopathy (including prothrombotic conditions such as Factor V Leiden, APC resistance, AT-III deficiency, and lupus anticoagulant), or recent arterial or deep venous thrombosis within the preceding 6 months
- •6. Change in corticosteroid or immunosuppressant (azathioprine, mycophenolate mofetil, cyclosporine) dose within 2 weeks prior to Day 1 (more than 10% variation from Day 1 daily doses)
- •7. Treatment with thrombopoietin (TPO) receptor agonists within 2 weeks before Day 1
- •8. Treatment with rituximab or splenectomy within the 8 weeks prior to Day 1
- •9. Treatment with IVIGs within 4 weeks prior to Day 1
- •10. Infections requiring intravenous antibiotics or hospitalization within 3 months prior to Day 1
- •11. Subject had positive test results at Screening for human immunodeficiency virus, hepatitis B surface antigen, or hepatitis C virus antibody or positive result for hepatitis B core antibody with a negative result for hepatitis B surface antigen
- •12. Live vaccine within 28 days prior to Day 1 or plan to receive one during the study
- •13. History or presence of any gastrointestinal, hepatic, or renal disease or any other condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs
- •14. Subject has not recovered from a recent medical/surgical procedure or trauma by Day 1 as determined by the investigator
- •15. Uncontrolled hypertension (as defined by systolic blood pressure =160 mmHg or diastolic blood pressure =100 mmHg)
- •16. Subject had ECG findings of corrected QT interval by Fridericia formula (QTcF) > 480 msec, cardiac arrhythmias, or clinically significant cardiac or ECG abnormalities
- •17. Subject have received any investigational medication within 30 days or 5 half lives prior to Day 1, whichever was longer
- •18. Concomitant use of any anticoagulants and platelet aggregation inhibiting drugs including aspirin (within 14 days of planned dosing through end of follow-up)
- •19. Female subject who is currently pregnant or breastfeeding
- •20. Prior treatment with a SYK inhibitor
- •21. Planned surgery in the time frame of the dosing period.
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