EUCTR2012-003632-23-ES进行中（未招募）1 期
A Phase 2/3, Open-label, Single Arm, Multicentre Study to Assess Safety, Tolerability, Pharmacokinetics and Efficacy of Intravenous Multiple Administrations of NI-0501, an Anti-interferon Gamma (Anti-IFN Gamma) Monoclonal Antibody, in Paediatric Patients with Primary Haemophagocytic Lymphohistiocytosis (HLH)
ovImmune SA0 个研究点目标入组 38 人开始时间: 2013年2月15日最近更新:
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
- 38
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. Primary HLH patients of both genders, up to and including 18 years at diagnosis of HLH. The diagnosis of HLH must be made on the basis of the following criteria (as per HLH-2004 protocol):
- •a. A molecular diagnosis or familial history consistent with primary HLH
- •b. Five out of the eight criteria below are fulfilled:
- •- Splenomegaly
- •- Cytopenias affecting 2 of 3 lineages in the peripheral blood (hemoglobin < 90 g/L; platelets < 100 x 109/L; neutrophils < 1 x 109/L)
- •- Hypertriglyceridemia (fasting triglycerides > 3 mmol/L or > 265 mg/dL) and/or hypofibrinogenemia (<= 1.5 g/L)
- •- Hemophagocytosis in bone marrow, spleen or lymph nodes, with no evidence of malignancy
- •- Low or absent natural killer (NK)-cell activity
- •- Ferritin >= 500 microg/L
- •- Soluble CD25 (sCD25; i.e. soluble IL-2 receptor) >= 2400 U/mL.
- •2. Presence of active disease in patients as assessed by the treating physician.
- •3. Patients having already received HLH conventional therapy must fulfill one of the following criteria as assessed by the treating physician :
- •- Having not responded
- •- Having not achieved a satisfactory response
- •- Having not maintained a satisfactory response
- •- Showing intolerance to conventional treatment of HLH
- •At the time of enrollment, eligible patients might still be receiving treatment (induction or maintenance) or might have already discontinued it.
- •4. Informed consent signed by the patient (if ? 18 years old), or by the patient?s legally authorized representative(s) with the assent of patients who are legally capable of providing it.
- •5. Having received guidance on contraception for both male and female patients sexually active and having reached puberty:
- •Females of child-bearing potential, having a negative pregnancy test at screening, and unless true abstinence is in line with the preferred and usual lifestyle of the patient, must agree to use adequate method(s) of birth control from screening until 6 months after receiving last dose of the study drug. Males with partners(s) of child-bearing potential must agree to take appropriate precautions to avoid fathering a child from screening until 6 months after receiving last dose of the study drug.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 38
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 3
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Diagnosis of secondary HLH consequent to a proven rheumatic or neoplastic disease.
- •2. Body weight < 3 kg.
- •3. Patients treated with:
- •any T-cell depleting agents (such as anti-thymocyte globulin [ATG], anti-CD52) during the previous 2 weeks prior to screening
- •any other biologic drug within 5 times their defined half-life period, except for rituximab in case of documented B-cell EBV infection (a list of some of the most commonly used biologic half-lives will be included in the Study Specific Risk Management Plan)
- •4. Active mycobacteria, Shigella, Histoplasma capsulatum, Campylobacter, Leishmania or Salmonella infections.
- •5. Evidence of history of tuberculosis or of latent tuberculosis.
- •6. Positive serology for HIV antibodies, hepatitis B surface antigen or hepatitis C antibodies.
- •7. Presence of malignancy.
- •8. Patients who have another concomitant disease or malformation severely affecting cardiovascular, pulmonary, liver or renal function.
- •9. History of hypersensitivity or allergy to any component of the study regimen.
- •10. Receipt of a live or attenuated live (including BCG) vaccine within the previous 12 weeks prior to screening.
- •11. Pregnant or lactating female patients
研究者
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