EUCTR2016-003038-26-HU进行中（未招募）1 期
A Randomized, Double-blind, Placebo-controlled, Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX-113 in Patients with Primary Immune Thrombocytopenia
Argenx BVBA0 个研究点目标入组 36 人开始时间: 2016年11月30日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 36
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
入选标准
- •1. Ability to understand the requirements of the study, provide written informed consent (including consent for the use and disclosure of research-related health information), and comply with the study protocol procedures (including required study visits).
- •2. Male or female patients aged = 18 to = 85 years.
- •3. Eligible patients must receive standard-of-care treatment for ITP following the ASH guidelines and International Working Group (IWG) that has been stable in dose and frequency for at least 4 weeks prior to Screening. Standard-of-care may include oral corticosteroids and/or permitted oral immunosuppressants and/or TPO-R agonist (see Section 7.9.2).
- •4. Confirmed diagnosis of ITP according to the American Society of Hematology Criteria 2010 with blood platelet counts < 30 × 109/L and who have not experienced major bleeding in the last 4 weeks prior to Screening.1 Note: The average platelet counts must be < 30 × 109/L with no single reading > 35 × 109/L as measured on 2 separate occasions at least 1 day apart during the Screening.
- •5. Women of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test at Baseline prior to administration of IMP.
- •Women of childbearing potential are defined as all female patients unless they are post-menopausal (defined by continuous amenorrhea) for at least 1 year with follicle-stimulating hormone (FSH) > 40 IU/L or are surgically sterile (i.e., women who had a hysterectomy, both ovaries surgically removed, or have current documented tubal ligation or any other permanent female sterilization procedure). Follicle-stimulating hormone can be used to confirm post-menopausal status in amenorrheic patients not on hormonal replacement therapy if the value is within the post-menopausal range per the central laboratory.
- •6. Female participants of childbearing potential must agree to use a highly effective method of birth control (i.e., pregnancy rate of less than 1% per year) during the study and for 90 days after the discontinuation of IMP.
- •Contraceptive methods that result in a low failure rate when used consistently and correctly include methods such as combined hormonal contraception associated with inhibition of ovulation (oral, intravaginal, and transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, and implantable), intrauterine devices (IUDs), intrauterine hormone-releasing system, true sexual abstinence (when this is in line with the preferred and usual lifestyle of the participant-periodic abstinence [e.g., calendar, ovulation] and withdrawal methods are not acceptable methods of contraception), bilateral tubal occlusion, or a male partner who has had a vasectomy with documented aspermia post procedure. All female participants using hormonal contraceptive, especially those using mycophenolate, must also use a barrier method (i.e., condom or occlusive cap [diaphragm or cervical/vault caps]) and should have been stable on their hormonal contraceptive treatment for at least 4 weeks prior to Screening.
- •7. Non-sterilized male patients who are sexually active with a female partner of childbearing potential must use effective double contraception, of which 1 method must be a barrier method and the other another barrier method or highly effective form of cont
排除标准
- •1. Use of anticoagulants, or any drug with antiplatelet effect (e.g., acetylsalicylic acid [aspirin] or other salicylate containing medications, cyclooxygenase inhibitors, adenosine diphosphate (ADP) receptor inhibitors, phosphodiesterase inhibitors, glycoprotein IIB/IIIA inhibitors, adenosine reuptake inhibitors, thromboxane inhibitors, antimalarials, and prostacyclins) during the study and within 3 weeks prior to Screening.
- •2. Patients who have received any blood support or transfusion within 4 weeks prior to Screening.
- •3. Use of IVIg or anti-D immunoglobulin treatment within 4 weeks prior to Screening.
- •4. Use of recombinant thrombopoietin at any time.
- •5. Use of rituximab within 6 months prior to Screening. Use of any anti-CD20 other than rituximab at any time is not permitted.
- •6. Use of corticosteroids which has not been stable for at least 4 weeks prior to Screening.
- •7. Use of immunosuppressants is not permitted within 4 weeks prior to Screening, with the exception of the following oral immunosuppressants: azathioprine [up to 2.5 mg/kg/day], danazol [up to 15 mg/kg/day], mycophenolate mofetil [up to 3 g/day], mycophenolate sodium [up to 2160 mg/day]) which must have been stable for at least 4 weeks prior to Screening.
- •8. Use of any other biological therapy or investigational drug than those previously indicated within 3 months or 5 half-lives of the drug (whichever is longer) prior to Screening.
- •9. Received vaccinations within 4 weeks prior to Screening or planned during the study.
- •10. At Screening, have clinically significant laboratory abnormalities given as below:
- •a. Aspartate aminotransferase (AST) or ALT > 3 × upper limit of normal (ULN).
- •b. Total serum bilirubin of > 1.5 x ULN (except for Grade 1 hyperbilirubinemia as defined by the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], due solely to a documented medical diagnosis of Gilbert’s syndrome).
- •c. Serum creatinine of > 1.5 mg/dL or creatinine clearance < 50 mL/min (using Chronic Kidney Disease Epidemiology - Creatinine formula).
- •d. Hemoglobin = 9 g/L.
- •e. Thyroid stimulating hormone or thyroglobulin outside of the central laboratory normal range.
- •f. International normalized ratio (INR) > 1.5 or activated partial thromboplastin time > 1.5 × ULN.
- •g. Total immunoglobulin G (IgG) level < 6 g/L.
- •h. Presence of = 1+ proteinuria
- •11. History of myeloproliferative or lymphoproliferative disorders at any time; or have a history of malignancy at any time unless deemed cured by adequate treatment with no evidence of recurrence for = 5 years prior to Screening. Patients with completely excised nonmelanoma skin cancers or cervical carcinoma in situ would be permitted at any time.
- •12. History of cerebrovascular accident or myocardial infarction within the last 12 months, before Screening, or current severe/unstable angina, arrhythmia, or at risk of ventricular arrhythmia, symptomatic congestive heart failure (New York Heart Association Class III or IV), or uncontrolled hypertension (Grade 3 to 4 CTCAE). Uncontrolled hypertension is defined as a repeated elevation in the blood pressure exceeding 140 mmHg and over 90 mmHg despite appropr
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