CTIS2023-509401-71-00招募中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). - EFC17093
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 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
入排标准
- 年龄范围
- 0 至 65+（—）
- 性别
- All
入选标准
- •1. Patients 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. 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, insufficient response or any contra-indication 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, AST/ALT =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. 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.
排除标准
- •1. Patients with secondary ITP., 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 - Patients 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 - Patients who previously received rilzabrutinib at any time are not eligible., 9. History of solid organ transplant., 12. Planned surgery in the time frame of the dosing period., 10. Myelodysplastic syndrome., 11. Live vaccine within 28 days prior to Study Day 1 or plan to receive one during the study., 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 - Patients treated with rituximab will have normal B-cell counts prior to enrollment.
研究者
相似试验
进行中（未招募）
1 期
Research study of Rolapitant versus Placebo for the prevention of nausea and vomiting related to chemotherapy that has a high likelihood of inducing nausea and vomiting.Chemotherapy-Induced Nausea and Vomiting (CINV) in Subjects Receiving Highly Emetogenic Chemotherapy (HEC)MedDRA version: 14.1 Level: PT Classification code 10054133 Term: Prophylaxis of nausea and vomiting System Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 14.1 Level: LLT Classification code 10049091 Term: Chemotherapy antiemetic prophylaxis System Organ Class: 10042613 - Surgical and medical proceduresEUCTR2010-022742-25-ESTesaro, Inc.526
进行中（未招募）
不适用
Research study of Rolapitant versus Placebo for the prevention of nausea and vomiting related to chemotherapy that has a high likelihood of inducing nausea and vomiting.Chemotherapy-Induced Nausea and Vomiting (CINV) in Subjects Receiving Highly Emetogenic Chemotherapy (HEC)MedDRA version: 16.0Level: PTClassification code 10054133Term: Prophylaxis of nausea and vomitingSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 16.0Level: LLTClassification code 10049091Term: Chemotherapy antiemetic prophylaxisSystem Organ Class: 10042613 - Surgical and medical proceduresEUCTR2010-022742-25-PTTesaro, Inc.530
进行中（未招募）
不适用
AMG 102 Plus ECX for Unresectable Locally Advanced or Metastatic Gastricor Esophagogastric Junction CancerEUCTR2011-004923-11-ITAMGEN INC.450
进行中（未招募）
不适用
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous LY2127399 in Patients with Systemic Lupus Erythematosus (SLE) (ILLUMINATE-2) - ILLUMINATE-2Systemic Lupus Erythematosus (SLE)MedDRA version: 14.1Level: LLTClassification code 10025139Term: Lupus erythematosus systemicSystem Organ Class: 100000004859EUCTR2010-022100-42-HUEli Lilly and Company1,140
进行中（未招募）
不适用
Study Evaluating the Efficacy and Safety of Bapineuzumab in Alzheimer Disease Patients Who Are Apolipoprotein E e4 CarriersAlzheimer DiseaseMedDRA version: 14.1Level: PTClassification code 10012271Term: Dementia Alzheimer's typeSystem Organ Class: 10029205 - Nervous system disordersEUCTR2007-005995-14-FIWyeth Pharmaceuticals Inc, a wholly owned subsidiary of Pfizer Inc, 500 Arcola road, Collegeville, PA 19426 USA1,100