EUCTR2012-003632-23-IT进行中（未招募）不适用
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?) 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: 2012年10月22日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 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
- 性别
- All
入选标准
- •1. Primary HLH patients of both genders, up to and including 18 years at
- •diagnosis of HLH, or at an age appropriate to be treated in the
- •investigator's practice. The diagnosis must be made on the following
- •criteria (as per HLH-2004 protocol):
- •a. A molecular diagnosis or familial history consistent with primary HLH
- •b. 5 out of 8 criteria below are fulfilled:
- •- Splenomegaly
- •- Cytopenias affecting 2 of 3 lineages in the peripheral blood
- •(hemoglobin <90g/L; platelets <100x10^9/L; neutrophils <1x10^9/L)
- •- Hypertriglyceridemia (fasting triglycerides >3mmol/L or >265mg/dL)
- •and/or hypofibrinogenemia (=1.5g/L)
- •- Hemophagocytosis in bone marrow, spleen or lymph nodes, with no evidence of malignancy
- •- Low or absent natural killer (NK)-cell activity
- •- Ferritin =500µg/L
- •- Soluble CD25 (sCD25; i.e. soluble IL-2 receptor) =2400U/mL
- •2. Presence of active disease as assessed by 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 of conventional HLH treatment
- •At the time of enrollment, eligible patients might still be receiving
- •treatment (induction or maintenance) or might have discontinued it.
- •4. Informed consent signed by the patient (if =18 years old) or by their
- •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 partner(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 latent tuberculosis.
- •6. Positive serology for HIV antibodies, hepatitis B surface antigen or
- •hepatitis C antibodies.
- •7. Presence of malignancy.
- •8. Patient who have another concomitant disease or malformation
- •severely affecting the cardiovascular, pulmonary, liver or renal function.
- •9. History of hypersensitivity or allergy to any components of the study
- •10. Receipt of a live or attenuated live (including BCG) vaccine within the
- •last 12 weeks before screening.
- •11. Pregnant or lactating female patients.
研究者
相似试验
进行中（未招募）
1 期
A study to investigate the safety and efficacy of a new drug, NI-0501, in children with a disease that is called Primary Haemophagocytic LymphohistiocytosisEUCTR2012-003632-23-GBovImmune SA38
进行中（未招募）
1 期
A study to investigate the safety and efficacy of a new drug, NI-0501, in children with a disease that is called Primary Haemophagocytic LymphohistiocytosisEUCTR2012-003632-23-SEovimmune SA38
进行中（未招募）
1 期
A study to investigate the safety and efficacy of a new drug, NI-0501, in children with a disease that is called Haemophagocytic Lymphohistiocytosis.Haemophagocytic lymphohistiocytosis.MedDRA version: 19.0 Level: SOC Classification code 10010331 Term: Congenital, familial and genetic disorders System Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2012-003632-23-ESovImmune SA38
进行中（未招募）
1 期
A Phase IIIb, Single Arm, Open-label, Multicentre Study of Durvalumab in Combination with Chemotherapy for the First Line Treatment for Patients with Advanced Biliary Tract Cancers (TOURMALINE)Advanced Biliary Tract CancersMedDRA version: 20.0Level: LLTClassification code: 10004676Term: Biliary tract disease Class: 10019805CTIS2022-502043-35-00AstraZeneca AB200
招募中
1 期
A Phase IIIb, Single Arm, Open-label, Multicentre Study of Durvalumab in Combination with Chemotherapy for the First Line Treatment for Patients with Advanced Biliary Tract Cancers (TOURMALINE)Advanced Biliary Tract CancersMedDRA version: 20.0Level: LLTClassification code: 10004676Term: Biliary tract disease Class: 10019805CTIS2022-502043-35-01AstraZeneca AB216