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临床试验/EUCTR2016-003038-26-GB
EUCTR2016-003038-26-GB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, followed by an Open-Label Treatment Period - ARGX-113-1603_Argenx BVBA

Argenx BVBA0 个研究点目标入组 38 人开始时间: 2016年11月16日最近更新:
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试验速览

阶段
1 期
状态
进行中（未招募）
发起方
入组人数
38
研究概览入排标准研究者记录与标识符相似试验

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. Ability to understand the requirements of the study, 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) stable in dose and frequency for at least 4 weeks prior to Screening.
  • •4. Confirmed diagnosis of ITP according to the American Society of Hematology Criteria 2011 with (average) blood platelet counts < 30 × 10E9/L and who have not experienced major bleeding in the last 4 weeks prior to 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.
  • •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.
  • •7. Non-sterilized male patients who are sexually active with a female partner of childbearing potential must use effective double contraception
  • •Additional Inclusion Criteria for the Extended Follow-up Period
  • •- Sign the amended ICF of the main study including its extended follow-up period
  • •- Completed Visit 16 of the FU period of the protocol with a platelet count = 30 × 10E9/L and/or at least doubling of the Baseline platelet count and absence of bleeding and remained on the same SoC
  • •Eligibility criteria for the open-label treatment period (first treatment cycle)
  • •1. Please refer to inclusion criteria 5, 6 and 7 from the main study.
  • •2. Provide written informed consent
  • •3. Received at least 3 doses of the IMP and had at least 2 weeks of follow-up in the main study.
  • •4. Patient is at the same SoC as in the main study. Dose and/or frequency increase is allowed, changing or stopping the SoC is not allowed.
  • •5. During up to 21 weeks of FU, the patient is relapsing i.e. platelet count decreases to below 30 x 10E9/L or the patient’s platelets never went up to 30 x 10E9/L and are still below 30 x 10E9/L, and absence of bleeding.
  • •Eligibility criteria for subsequent open-label retreatment cycles
  • •The patient has the right to receive more than 1 retreatment cycle if:
  • •1. Patient reached a platelet count of at least twice the platelet count measured on the day of the first IMP administration during the previous (re)treatment cycle, confirmed on at least 2 separate consecutive occasions (at least 1 day apart but with maximum 7 days in between the 2 measurements), and measured during the treatment period up to minimum 4 weeks of follow-up.
  • •2. Patient received at least 3 doses of the IMP and had at least 4 weeks follow-up in the previous treatment cycle.
  • •3. Patient is at the same SoC as in the previous treatment cycle. Dose and/or frequency increase is allowed, changing or stopping the SoC is not allowed.
  • •4. Patient is relapsing i.e. platelet count decreases to below 30 x 10E9/L or the patient’s platelets never went up to 30 x 10E9/L and are still below 30 x 10E9/L, and absence of bleeding.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range: 0
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range 22
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 14

排除标准

  • •1. Use of anticoagulants, or any drug with antiplatelet effect 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
  • •5. Use of rituximab within 6 months prior to Screening. other anti-CD20s not permitted
  • •6. Use of corticosteroids not been stable for at least 4 weeks prior to Screening
  • •7. Use of immunosuppressants not permitted within 4 weeks prior to Screening except azathioprine, danazol, mycophenolate mofetil, mycophenolate sodium 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
  • •11. History of myeloproliferative or lymphoproliferative disorders at any time; or history of malignancy at any time unless deemed cured
  • •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
  • •13. History of any thrombotic or embolic event within 12 months prior to Screening
  • •14. History of coagulopathy or hereditary thrombocytopenia or a family history of thrombocytopenia
  • •15. Known history or symptoms of systemic lupus erythematosus, antiphospholipid antibody syndrome or any other clinically documented auto-immune disease other than ITP
  • •16. Prior history or symptoms suggestive of untreated Helicobacter pylori infection
  • •17. History of a recent major surgery
  • •18. Active infection; a recent serious infection within the 8 weeks prior to Screening.
  • •19. Clinical evidence of significant unstable or uncontrolled acute or chronic diseases other than ITP, uncontrolled diabetes
  • •20. History of alcoholism or drug/chemical/substance abuse within the past 2 years prior to Screening per investigator’s opinion
  • •21. Body Mass Index (BMI) at Screening = 35 kg/m2
  • •22. Female patient who is pregnant or lactating or have been lactating within 3 months of Screening
  • •Additional Exclusion Criterion for the Extended Follow-up Period
  • •23. At the moment of start of extended FU period, being enrolled in a clinical study with another investigational drug or device
  • •Exclusion criteria for the open-label treatment period (first treatment cycle)
  • •1. At the moment of start of the open-label treatment period, being enrolled in a clinical study with another investigational drug or device
  • •2. Please refer to the following exclusion criteria from the main study: 1, 4, 19, 21, and 22
  • •3. Use of IVIg or anti-D immunoglobulin treatment as rescue therapy at any time during the main study or extended FU period
  • •4. Received vaccinations within 4 weeks prior to any (re)treatment cycle
  • •5. At Treatment Evaluation Visit, have clinically significant laboratory abnormalities
  • •6. Patient has a history of severe and/or serious hypersensitivity reaction to IMP in ARGX- 113-1603 main study
  • •Exclusion criteria for subsequent open-label retreatment cycles
  • •1. Please refer to the exclusion criteria for the first treatment cycle of the open-label treatment period
  • •2. Patient has a histor

研究者

发起方
Argenx BVBA

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