EUCTR2020-002063-60-PL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
- 224
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. Participants will be male and female with primary ITP with duration of >6 months in pediatric participants aged 12 to <18 years (pediatric participants aged 10 to <12 years will be enrolled in the EU [EEA countries] only) and duration of >3 months in ages 18 years and above
- •2. Participants 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, insufficient response or any contraindication to any appropriate courses of standard of care ITP therapy
- •3. An average of 2 platelet counts at least 5 days apart of <30,000/µL during the Screening period and no single platelet count >35,000/µL, within 14 days prior to the first dose of study drug
- •- Pediatric patients must additionally be determined to need treatment for ITP as per clinical assessment by the Investigator
- •4. Adequate hematologic, hepatic, and renal function (absolute neutrophil count =1.5 X 10^9/L, aspartate aminotransferase/alanine aminotransferase =1.5 x upper limit of normal [ULN], albumin =3 g/dL, total bilirubin =1.5 x ULN [unless the patient has documented Gilbert syndrome], glomerular filtration rate >50 [Cockcroft and Gault method])
- •5. Hemoglobin >9 g/dL within 1 week prior to Study Day 1
- •6. All contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
- •7. Participants 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 169
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
排除标准
- •1. Participants with secondary ITP
- •2. Pregnant or lactating women
- •3. 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
- •4. 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
- •5. Change in CS and/or TPO-RA dose within 14 days prior to Study Day 1 (more than 10% variation from current doses)
- •6. Immunosuppressant drugs other than CSs within 5 times the elimination half-life of the drug or 14 days of Study Day 1, whichever is longer
- •7. Treatment with rituximab or splenectomy within the 3 months prior to
- •Study Day 1
- •- Participants treated with rituximab will have normal B-cell counts prior to enrollment
- •8. 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
- •- Participants who previously received treatment with Bruton's Tyrosine Kinase (BTK) inhibitors (except rilzabrutinib) within 30 days before the first dose of study drug are not eligible
- •- Participants who previously received rilzabrutinib at any time are not eligible
- •9. History of solid organ transplant
- •10. Myelodysplastic syndrome
- •11. Live vaccine within 28 days prior to Study Day 1 or plan to receive one during the study
- •12. Planned surgery in the time frame of the dosing period
研究者
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