EUCTR2015-003652-52-GB进行中（未招募）1 期
An open label, prospective, multicenter study investigating clinical efficacy, safety, and pharmacokinetic properties of the human normal immunoglobulin for intravenous administration BT595 as replacement therapy in patients with primary immunodeficiency disease (PID)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Biotest AG
- 入组人数
- 60
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
- •a) Written informed consent/assent obtained from subjects/subjects’ parent(s) or legally acceptable representative indicating that they understand the purpose of and procedures required for the study and are willing to participate in it.
- •b) Male or female, aged 2 through 75 years.
- •c) Diagnosis of PID with impaired antibody production, i.e.:
- •- Diagnosis of common variable immunodeficiency (CVID) as defined by the European Society for Immunodeficiencies (ESID)/Pan American Group for Immunodeficiency (PAGID) diagnostic criteria.
- •- X linked agammaglobulinemia (XLA) as defined by ESID/PAGID diagnostic criteria.
- •d) Established replacement therapy with any intravenous immunoglobulin (IVIg) reference preparation during the previous 6 months, including documentation of immunoglobulin G (IgG) trough levels.
- •e) Established replacement therapy with a single IVIg reference preparation for at least 3 months prior to treatment start with BT595 at a 3 or 4 week schedule with a constant IVIg dose that did not change by ±20% of the mean dose, regular dosage intervals, and at least 1 IgG trough level of =5 g/L during the previous 3 months.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 20
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 35
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •a) Pregnancy or unreliable contraceptive measures or lactation period (females only).
- •b) Known intolerance to immunoglobulins or comparable substances (e.g., vaccination reaction).
- •c) Known intolerance to proteins of human origin or known allergic reactions to components of the study product.
- •d) Participation in another clinical study within 30 days before entering the study or during the study and/or previous participation in this study.
- •e) Employee or direct relative of an employee of the Contract Research Organization, the study site, or Biotest.
- •f) Acquired medical conditions known to cause secondary immune deficiency, such as chronic lymphatic leukemia, lymphoma, multiple myeloma, as well as protein losing enteropathies and hypoalbuminemia.
- •g) Other medical condition, laboratory finding, or physical examination finding that precludes participation.
- •h) Recent febrile illness that precludes or delays participation.
- •i) Active infection and receiving antibiotic therapy for the treatment of this infection at the time of screening. Note: if the subject is deemed to be a screen failure due to a nonserious active infection requiring antibiotic therapy, the subject may be rescreened after the initial screening.
- •j) Therapy with systemic steroids or other immunosuppressant drugs at the time of enrollment (current daily use of corticosteroids, i.e., >10 mg prednisone equivalent/day for >30 days. Intermittent corticosteroid use during the study is allowable, if medically necessary).
- •k) History of thrombotic events (including myocardial infarction, cerebral vascular accident [including stroke], pulmonary embolism, and deep vein thrombosis) within the 6 months before treatment start with BT595 or the presence of significant risk factors for thrombotic events.
- •l) Therapy with live attenuated virus vaccines within 3 months before start of the study.
- •m) Selective, absolute immunoglobulin A (IgA) deficiency or known antibodies to IgA.
- •n) Positive diagnosis of hepatitis B or hepatitis C.
- •o) Positive HIV test.
- •p) History of drug or alcohol abuse within the 12 months before treatment start with BT595.
- •q) Inability or lacking motivation to participate in the study.
研究者
相似试验
进行中（未招募）
1 期
An open label, prospective, multicenter study investigating clinical efficacy, safety, and pharmacokinetic properties of the human normal immunoglobulin for intravenous administration BT595 as replacement therapy in patients with primary immunodeficiency disease (PID)Replacement therapy in patients with primary immunodeficiency disease (PID)MedDRA version: 20.0Level: PTClassification code 10064859Term: Primary immunodeficiency syndromeSystem Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2015-003652-52-DEBiotest AG70
进行中（未招募）
1 期
An open label, prospective, multicenter study investigating clinical efficacy, safety, and pharmacokinetic properties of the human normal immunoglobulin for intravenous administration BT595 as replacement therapy in patients with primary immunodeficiency disease (PID)EUCTR2015-003652-52-ESBiotest AG60
进行中（未招募）
不适用
An non-blinded, mulicenter study to investigate the mechanisms which are involved in the interaction of red blood cells with the study drug IgPro10 in patients with chronic immune thrombocytopenic purpura (ITP) who have shown signs of hemolysis (a breakdown or destruction of red blood cells).Chronic immune thrombocytopenic purpura (ITP)MedDRA version: 16.0Level: PTClassification code 10021245Term: Idiopathic thrombocytopenic purpuraSystem Organ Class: 10005329 - Blood and lymphatic system disordersEUCTR2011-000263-27-BGCSL Behring GmbH150
进行中（未招募）
不适用
An non-blinded, mulicenter study to investigate the mechanisms which are involved in the interaction of red blood cells with the study drug IgPro10 in patients with chronic immune thrombocytopenic purpura (ITP) who have shown signs of hemolysis (a breakdown or destruction of red blood cells).Chronic immune thrombocytopenic purpura (ITP)MedDRA version: 15.0Level: PTClassification code 10021245Term: Idiopathic thrombocytopenic purpuraSystem Organ Class: 10005329 - Blood and lymphatic system disordersEUCTR2011-000263-27-PLCSL Behring LLC150
已完成
3 期
Evaluation of DEAT0217 versus standard of care to compare effectiveness and safety in treating moderate psoriasis in adult patientsAdult patients diagnosed with mild to moderate psoriasis.Skin and Connective Tissue DiseasesISRCTN28479470Devintec SAG42