EUCTR2004-000537-11-DE进行中（未招募）不适用
An open-label, multicenter study on the efficacy and safety of IgPro10 in patients with chronic immune thrombocytopenic purpura (ITP)
ZLB Behring AG0 个研究点目标入组 60 人开始时间: 2004年9月14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
- 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
- •Male or female patients aged 18 – 65 years
- •Diagnosis of chronic ITP defined by:
- •Failure to find other causes of thrombocytopenia
- •Platelet count = 150 x 10 (9) /L over 6 months or response to a previous
- •treatment with subsequent decrease in platelet count even if duration of
- •chronic ITP is less than 6 months
- •Platelet counts = 20 x 10 (9) /L
- •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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Treatment with IVIG or anti-D immunoglobulin within 3 weeks prior to screening.
- •Treatment with IV steroids within 10 days prior to screening.
- •Change of oral steroid treatment within 15 days prior to screening.
- •Patients with known or suspected hypersensitivity to immunoglobulins or previous severe side effects to immunoglobulin therapy.
- •Patients with a history of migraine.
- •Patients with known hyperprolinemia.
- •Abnormal results in the following laboratory parameters:
- •Hemoglobin < 10 g/dL
- •Total bilirubin > 1.5 x upper normal limit
- •ALAT > 2.5 x upper normal limit
- •ASAT > 2.5 x upper normal limit
- •Creatinine > 1.5 x upper normal limit
- •Urea > 1.5 x upper normal limit
- •Patients with low serum IgA level, defined by < 50% lower normal limit.
- •Patients with one of the following concomitant diseases:
- •Clinical active SLE
- •Lymphoproliterative disease
- •Heart failure Grade III or IV according to the New York Heart Association
- •classification
- •Any other concomitant disease that has influence on the clotting system (i.e. hemophilia)
研究者
相似试验
进行中（未招募）
不适用
An open label, multi-center study on the efficacy and safety of IgPro10 in patients with chronic immune thrombocytopenic purpura ITPEUCTR2004-000537-11-ITZLB BEHRING60
进行中（未招募）
不适用
A multicenter, open-label study on the efficacy, cycle control and safety of a contraceptivevaginal ring delivering a daily dose of 150 µg of Nestorone(R) and 15 µg of ethinyl estradiol (150/15 NES/EE CVR)As the trial is intended to investigate a new contraceptive medicinal product, the study subjects included are not characterized by a specific medical condition.MedDRA version: 8.1Level: PTClassification code 10010808Term: ContraceptionEUCTR2005-004978-25-HUInternational Committee for Contraception Research of the Population Council2,200
进行中（未招募）
不适用
A multicenter, open-label study on the efficacy, cycle control and safety of a contraceptivevaginal ring delivering a daily dose of 150 µg of Nestorone(R) and 15 µg of ethinyl estradiol (150/15 NES/EE CVR)As the trial is intended to investigate a new contraceptive medicinal product, the study subjects included are not characterized by a specific medical condition.MedDRA version: 8.1Level: PTClassification code 10010808Term: ContraceptionEUCTR2005-004978-25-SEInternational Committee for Contraception Research of the Population Council2,200
进行中（未招募）
不适用
A multicenter, open-label study on the efficacy, cycle control and safety of a contraceptivevaginal ring delivering a daily dose of 150 µg of Nestorone(R) and 15 µg of ethinyl estradiol (150/15 NES/EE CVR)As the trial is intended to investigate a new contraceptive medicinal product, the study subjects included are not characterized by a specific medical condition.MedDRA version: 8.1Level: PTClassification code 10010808Term: ContraceptionEUCTR2005-004978-25-FIInternational Committee for Contraception Research of the Population Council2,200
进行中（未招募）
不适用
An open, multicenter study to evaluate the efficacy and safety of a 4 week therapy with CoDiovan 160/25 (fixed dose combination of valsartan 160 mg plus HCTZ 25 mg) in patients not adequately responding to a 4 week monotherapy with olmesartan medoxomil 40 mg or combination therapy with olmesartan medoxomil 20 mg plus HCTZ 12.5 mg - VALORYpatients with hypertensionMedDRA version: M15Level: LLTClassification code 10020772EUCTR2004-002534-18-DEovartis Pharma GmbH