EUCTR2013-004383-62-GB进行中（未招募）1 期
An open label Safety and Efficacy extension study of GreenGene™ F in Previously Treated Patients Diagnosed with Severe Hemophilia A
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 150
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.Subjects must have participated in the GreenGene™ F_P3”, (with Eudra CT number 2012-001445-40) or a pediatric study with GreenGene™ F
- •2.Have = 50 previous exposure days to GreenGene™ F, as documented in the subject’s medical records.
- •3.Negative assays for FVIII inhibitor at inclusion (<0.6BU Nijmegen assay), i.e. at the end of study GreenGene™ F_P3” for patients entering into this extension study immediately after finishing the previous phase III study.
- •4.Normal liver and kidney function
- •5.Platelet count = 100,000 µL
- •6.Normal prothrombin time or International Normalized Ratio (INR) < 1.5
- •7.Subjects receiving therapy for human immunodeficiency virus (HIV) or hepatitis must be on a stable treatment regimen
- •8.Subjects must be able to withhold FVIII infusions for approximately 72 h prior to each inhibitor assay
- •9.Absolute CD4 lymphocyte cell count = 200 µL
- •10.Signed the written informed consent form or informed consent was obtained from the subject’s legal guardian
- •11.Females must not be lactating or pregnant at Screening or Baseline (as documented by a negative beta-human chorionic gonadotropin [ß hCG] test with a minimum sensitivity of 25 IU/L or equivalent units of ß hCG). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug
- •12.All females will be considered to be of childbearing potential unless they are postmenopausal (amenorrhoic for at least 12 consecutive months, in the appropriate age group and without other known or suspected cause) or have been sterilized surgically (i.e. bilateral tubal ligation, total hysterectomy or bilateral oophorectomy, all with surgery at least one month before dosing)
- •13.Willing and able to comply with all aspects of the protocol
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 50
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 90
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •1.Presence at Screening of FVIII inhibitor = 0.6 BU as tested with the Nijmegen modification of the Bethesda assay.
- •2.Laboratory or clinical evidence of portal vein hypertension including, but not limited to, an INR > 1.4, the presence of splenomegaly and/or spider angiomata of physical examination and/or a history of esophageal hemorrhage or documented esophageal varices
- •3.Uncontrolled hypertension (diastolic blood pressure >100 mm Hg)
- •4.Hemoglobin < 10 g/dL
- •5.Severe renal dysfunction (creatinine > 2x upper limit of normal [ULN], total bilirubin > 2x the ULN)
- •6.Liver disease (alanine aminotransferase [ALT], aspartate aminotransferase [AST] > 3x the ULN)
- •7.History of diabetes or other metabolic disease
- •8.History of hypersensitivity or serious adverse reaction to recombinant or plasma-derived FVIII concentrates
- •9.History of pretreatment prior to the administration of FVIII products (e.g., antihistamines)
- •10.Regular use of antifibrinolytics or medications affecting platelet function
- •11.Hypersensitivity to hamster-or mouse derived proteins
- •12.Blood transfusions within 30 days of enrollment into the study
- •13.Current participation in another investigational drug or device study, or participated in a clinical study involving an investigational drug or device within 30 days of enrollment into the study
- •14.Unable or unwilling to cooperate with study procedures
- •15.Females who are pregnant (positive ß-hCG test) or breastfeeding
研究者
相似试验
进行中（未招募）
不适用
An open label extension study to evaluate safety, tolerability, and efficacy of 18 weeks of valsartan treatment in children 1-5 years old with hypertension. - NDhypertensionEUCTR2006-005473-21-ITOVARTIS FARMA68
进行中（未招募）
不适用
Open-Label Extension Study to Assess the Safety and Seizure Frequency Associated With Lacosamide for Primary Generalized Tonic-Clonic Seizures in Subjects With EpilepsyMedDRA version: 17.1Level: PTClassification code 10015037Term: EpilepsySystem Organ Class: 10029205 - Nervous system disordersEpilepsyEUCTR2014-004375-23-Outside-EU/EEACB BIOSCIENCES, Inc.45
进行中（未招募）
1 期
An open label extentsion study to evaluate safety, tolerability, and efficacy of 18 weeks of valsartan treatment in children 6 months -5 years old with hypertension.HypertensionEUCTR2006-005473-21-BEovartis Pharma Services AG66
进行中（未招募）
不适用
An open label extentsion study to evaluate safety, tolerability, and efficacy of 18 weeks of valsartan treatment in children 1-5 years old with hypertension.HypertensionEUCTR2006-005473-21-HUovartis Pharma Services AG68
进行中（未招募）
不适用
An open label extentsion study to evaluate safety, tolerability, and efficacy of 18 weeks of valsartan treatment in children 1-5 years old with hypertension.HypertensionEUCTR2006-005473-21-DEovartis Pharma Services AG68