EUCTR2020-002063-60-GB进行中（未招募）1 期
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-Controlled, Parallel-Group Study with an Open-Label Extension to Evaluate the Efficacy and Safety of Oral Rilzabrutinib (PRN1008) in Adults and Adolescents with Persistent or Chronic Immune Thrombocytopenia (ITP)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 194
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. Patients will be men and women with primary ITP with duration of > 6 months in ages 12 to < 18 years and duration of > 3 months in ages 18 years and above
- •2. Patients who had a response (achievement of platelet count = 50,000/µL) to IVIg/anti-D or CSs that was not sustained and who have documented intolerance or insufficient response to any appropriate courses of standard of care ITP therapy
- •3. An average of 2 platelet counts at least 5 days apart of < 30,000µL (and no single platelet count >35,000µL) within 14 days prior to the first dose of study drug
- •4. Adequate hematologic, hepatic, and renal function (absolute neutrophil count = 1.5 X 109/L, AST/ALT = 1.5 x ULN, albumin = 3 g/dL, total bilirubin = 1.5 x ULN, estimated GFR > 50 (Cockcroft and Gault method)
- •5. Hemoglobin (Hgb) > 9 g/dL prior to dosing on Study Day 1
- •6. Female patients who are of reproductive potential (or are likely to reach reproductive potential during the study) must agree for the duration of the study to use an effective means of contraception (e.g. hormonal contraception methods that inhibit ovulation, intrauterine device, intrauterine hormone-releasing system, bilateral tubal ligation, vasectomized partner or condoms) or practice true abstinence (when this is in line with the usual and preferred lifestyle). For females considered not to have reproductive potential: Any woman of age = 55 years with amenorrhea for >1 year, will be considered as having confirmed menopause and follicle-stimulating hormone (FSH) or pregnancy testing will not be needed. Postmenopausal females <55 years of age (defined as amenorrhea > 1 year) must have menopause confirmed by elevated FSH levels at Screening. Surgically sterile females do not require any further confirmation of menopause and will not be considered to have reproductive potential.
- •7. Patients must be able to provide written informed consent or informed assent with corresponding informed consent obtained from the patient’s guardian and agree to the schedule of assessments.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 30
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 139
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
排除标准
- •1. Patients with secondary ITP
- •2. Pregnant or lactating women
- •3. Electrocardiogram (ECG) findings for patients:
- •aged = 12 and < 16: QTc > 449 msec (males) or > 457 msec (females)
- •aged = 16 and < 18: QTc >450 msec (males) or > 460 msec (females)
- •aged = 18, 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
- •4. History (within 5 years of Study Day 1) or current, active malignancy requiring or likely to require chemotherapeutic or surgical treatment during the study, with the exception of non-melanoma skin cancer
- •5. Transfusion with blood, blood products, plasmapheresis, or use of any other rescue medications with intent to increase platelet count within 14 days before Study Day 1
- •6. Change in CS and/or TPO-RA dose within 14 days prior to Study Day 1 (more than 10% variation from current doses)
- •7. Immunosuppressant drugs other than CSs within 14 days of Study Day 1
- •8. Treatment with rituximab or splenectomy within the 3 months prior to Study Day 1
- •Patients treated with rituximab will have normal B-cell counts prior to enrollment
- •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 Study Day 1)
- •10. Use of known strong-to-moderate inducers or inhibitors of CYP3A within 3 days or 5 half-lives (whichever is longer) of Study Day 1 and until the end of the active treatment period
- •11. Planned or concomitant use of any anticoagulants and platelet aggregation inhibiting drugs such as aspirin (except for low dose aspirin up to 100 mg per day), nonsteroidal anti-inflammatory drugs (NSAIDs), thienopyridines within 14 days of Study Day 1 and until the end of the active treatment period
- •12. 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
- •Patients who previously received treatment with BTK inhibitors (except rilzabrutinib) within 30 days before the first dose of study drug are not eligible
- •Patients who previously received rilzabrutinib (PRN1008) at any time are not eligible
- •13. Current drug or alcohol abuse
- •14. Refractory nausea and vomiting, malabsorption, external biliary shunt, significant bowel resection, or any other condition that would preclude adequate study drug absorption
- •15. History of solid organ transplant
- •16. Positive at Screening for human immunodeficiency virus (HIV), hepatitis B virus (HBV) (surface and core antibodies unrelated to vaccination), or hepatitis C virus (anti-HCV antibody confirmed with Hep C RNA)
- •Patients who are hepatitis B virus surface antigen (HBsAg) positive will not be eligible
- •Patients who are HBsAg negative and hepatitis B core antigen antibody (HBcAb) positive will be tested for HBV surface antibody (HBsAb) and HBV DNA. If HBsAb titer is >100 IU/ml, patients may be enrolled. Monthly HBV DNA monitoring will be required while on treatment and for 6 months after the last dose of the study drug. Positive HBV DNA results will be managed appropriately as per local standard of care
- •Patients who are HBcAb positive and HBsAg negative with HBsAb titer <100 IU/ml or negative, are not eligible
- •17. Positive QuantiFERON®-T
研究者
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