EUCTR2018-003329-26-PL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. Both male and female subjects must agree to take the following steps to reduce the potential for transmission of genetic material containing the investigational product
- •a. Both male and female subjects, the subject and their partners of
- •childbearing potential must agree to use 2 of the following medically acceptable methods of contraception from the time of randomization, during the study, and for 6 months following discontinuation of study drug, of which:
- •o One must be a highly reliable method of contraception, such as:
- •? An intrauterine device or intrauterine system implanted for at least 30 days prior to Day 1
- •? Surgical sterilization of one of the partners for at least 6 months prior to the date of informed consent (assuming this will be the only partner for the whole duration of the clinical trial)
- •? Consistent and correct use of hormonal contraceptives (hormonal implants, injectables, contraception pills, transdermal patches, or contraceptive rings) for at least 30 days prior to Day 1
- •o One supplementary barrier method, such as:
- •? Male or female condom always with spermicide (a spermicidal
- •foam/gel/film/cream)
- •? Diaphragm or cervical/vault caps always with spermicide (a
- •spermicidal foam/gel/film/cream)
- •? Double-barrier methods (which means a barrier method used by both partners at the same time), even when used with spermicide, are not considered to be highly reliable contraception methods, and as such, may not be the only forms of contraception used
- •One of the other listed highly reliable methods must be used in
- •conjunction with a barrier method.
- •b. Female subjects must agree not to breastfeed starting from the time of Screening, throughout the study, and until after 6 months following the last dose of study drug.
- •c. Male subjects must agree not to donate sperm starting from the time of randomization, throughout the study, and until after 6 months following the last dose of study drug
- •d. For subjects and partners considered not of childbearing potential, the following conditions apply:
- •a. Menopausal females must have experienced their last period more than 12 months prior to the date of informed consent to be classified as not of childbearing potential.
- •b. Male and female subjects are in a situation of abstinence from
- •heterosexual intercourse from Screening until after 6 months following the las
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 (HBsAg), or
- •hepatitis C virus antibody Subjects with past or resolved hepatitis B
- •infection (defined as having a negative HBsAg test and a positive IgG
- •antibody to hepatitis B core antigen [anti-HBc]) are eligible but hepatitis B virus (HBV) DNA must be obtained in these patients prior to Cycle 1, Day 1, and must demonstrate no active infection.
- •Subjects positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA
- •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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