EUCTR2019-004103-12-IT进行中（未招募）1 期
A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Tolerability and Efficacy of TAK-079 in Patients with Persistent/Chronic Primary Immune Thrombocytopenia - /
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 54
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
- •Each patient must meet all the following inclusion criteria to be to be randomized to treatment:
- •1. Age 18 years or older and able and willing to comply with study procedures.
- •2. Diagnosed with ITP that has persisted for =3 months, diagnosed in accordance to The American Society of Hematology 2011 Evidence-based Practice Guideline for Immune Thrombocytopenia or the International Consensus Report on The Investigation and Management of Primary Immune Thrombocytopenia as locally applicable.
- •3. Presents with a mean platelet count of <30,000/µL for the 4 weeks before the first study dose. The mean platelet count is based on at least 2 platelet counts within 4 weeks of dosing, including the value obtained at screening. No individual platelet count >35,000/µL during these times is allowed.
- •4. Has had 1 prior platelet response to any standard of care treatment to achieve a platelet count of =50,000/µL. Any standard treatment in this context may include therapies that are not
- •permitted concomitant therapies during the study.
- •5. If receiving standard background treatment for ITP, treatment should be stable in dose and frequency for at least 4 weeks before dosing.
- •a) Permitted standard background treatments may include: 1 oral corticosteroid; ±1 immunosuppressant from the following list: azathioprine, danazol, dapsone, cyclosporine, mycophenolate mofetil, mycophenolate sodium; ±1 TPO-RA (romiplostim, eltrombopag, avatrombopag); ±fostamatinib. Corticosteroids, including dexamethasone, must be given as oral, daily therapy as opposed to pulse therapy. High-dose pulse steroid therapy is not
- •allowed within 14 days before Day 1.
- •b) The dose of any permitted standard background therapy must be expected to remain stable through the study, unless dose reduction is required because of toxicities.
- •6. Female patients of childbearing potential are required to have a negative pregnancy test. Both female patients of childbearing potential and male patients must practice an effective, reliable,
- •and approved contraceptive regimen during the study and for up to 90 days or 5 half-lives, whichever is longer, after discontinuation of treatment.
- •7. Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.
- •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 18
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 36
排除标准
- •Patients meeting any of the following exclusion criteria are not to be randomized to treatment:
- •1. Use of anticoagulants or any drug with antiplatelet effect (such as aspirin) within 3 weeks before screening.
- •2. History of any thrombotic or embolic event within 12 months before screening.
- •3. History of splenectomy within 3 months before screening.
- •4. Use of IVIg, subcutaneous immunoglobulin or anti-D treatment within 4 weeks of screening.
- •5. Diagnosed with chronic obstructive pulmonary disease (COPD) or asthma, and a prebronchodilatory forced expiratory volume in 1 second (FEV1) <50% of predicted normal.
- •Note: FEV1 testing is required for patients suspected of having COPD or asthma.
- •6. Use of rituximab or any mAb for immunomodulation within 4 months before first dosing.
- •Note: Patients with prior exposure to rituximab must have CD19 counts within the normal range at screening.
- •7. Use of immunosuppressants (such as cyclophosphamide, vincristine) other than permitted oral immunosuppressants within 6 months before first dosing.
- •8. Diagnosed with myelodysplastic syndrome.
- •9. Has received vaccinations within 4 weeks before screening or has any vaccinations planned during the study.
- •10. Currently experiencing any medical condition that, in the opinion of the investigator, might interfere with the patient’s participation in the study (such as significant cardiovascular, pulmonary, hematologic, gastrointestinal, endocrinologic, hepatic, renal, neurologic, malignancy, or infectious disease), that poses an added risk for the patient, or could confound the assessment of the patient.
- •11. Pregnancy or lactation during screening period or on Day 1 before first dose of study drug.
- •12. Participation in any other investigational drug study or exposure to other investigational agent within 4 weeks or 5 half-lives, whichever is longer, before Day 1.
- •13. Has had an opportunistic infection =12 weeks before initial study dosing or is currently undergoing treatment for a chronic opportunistic infection, such as tuberculosis (TB), pneumocystis pneumonia, cytomegalovirus, herpes simplex virus, herpes zoster, or atypical mycobacteria.
- •14. Exhibits clinically significant laboratory abnormalities at screening:
- •a) Alanine aminotransferase or aspartate aminotransferase >3 times the upper limit of normal (ULN).
- •b) Total bilirubin >1.5 × ULN (Note: Patients with a confirmed diagnosis of Gilbert syndrome that is documented in the patient’s medical record are not excluded based on this criterion).
- •c) Absolute neutrophil count <1500/mm3.
- •d) Hemoglobin <8 g/dL.
- •e) IgG <500 mg/dL.
- •f) Lymphocyte count <500/mm3.
- •g) Creatinine clearance, CrCl, <30 mL/min (ie, CrCl =30 mL/min is allowed).
- •15. Has a positive T-cell interferon-¿ release assay (TIGRA) (results through QuantiFERON TB Gold test or T-Spot/Elispot) at the screening visit, noting the following:
- •a) A purified protein derivative (PPD) skin test may be used as a replacement, if TIGRA testing is not available.
- •b) Patients with an indeterminate TIGRA result must meet the following criteria:
- •– Has a negative PPD skin test (defined as <5 mm induration).
- •– Is at low risk of acquiring TB (eg, avoids close contact with TB positive individual[s]), and/or chest x-ray =6 months before the screening visit that is consistent with no evidence of latent or active TB).
- •16. Has a serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this prot
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