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临床试验/EUCTR2016-003038-26-BE
EUCTR2016-003038-26-BE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.

Argenx BVBA0 个研究点目标入组 36 人开始时间: 2016年12月8日最近更新:
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适应症

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 withthe 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
  • •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 followup
  • •- 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
  • •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
  • •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:
  • •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.
  • •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
  • •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
  • •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
  • •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
  • 另有 10 项未显示

研究者

发起方
Argenx BVBA

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