EUCTR2012-001445-40-GB进行中（未招募）1 期
Determination of Safety, Efficacy, and Pharmacokinetics of GreenGene™ F in Previously Treated Patients 12 years of age or older Diagnosed with Severe Hemophilia A - GreenGene F_P3
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 124
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.Male or female subjects age = 12 years at time of informed consent
- •2.Body weight = 35 kg
- •3.Diagnosed with severe hemophilia A. Subjects must have severe hemophilia A with baseline FVIII < 1 IU/mL
- •4.Have = 150 previous exposure days to FVIII concentrates, as documented in the subject’s medical records
- •5.Subjects included in the on-demand treatment cohort must have a verifiable record of at least three bleeding episodes per month on average in the last 6 months prior to enrollment
- •6.Negative assays for FVIII inhibitor at both local and central laboratories at inclusion (<0.6BU Nijmegen assay)
- •7.Negative assays for FVIII inhibitor in subject files (<0.6BU Nijmegen assay) No history of positive inhibitor is allowed
- •8.Normal liver and kidney function.
- •9.Platelet count = 100,000 µL
- •10.Normal prothrombin time or International Normalized Ratio (INR) < 1.5
- •11.Subjects receiving therapy for human immunodeficiency virus (HIV) or hepatitis must be on a stable treatment regimen
- •12.Subjects must be able to withhold FVIII infusions for approximately 72 h prior to each FVIII activity and inhibitor assay
- •13.Absolute CD4 lymphocyte cell count = 200 µL
- •14.Signed the written informed consent form or informed consent was obtained from the subject’s legal guardian
- •15.Females must not be lactating or pregnant at Screening or Baseline
- •16.All females will be considered to be of childbearing potential unless they are postmenopausal or have been sterilized surgically
- •17.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: 40
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 64
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •1.Presence at Screening of FVIII inhibitor = 0.6 BU as tested with the Nijmegen modification of the Bethesda assay in either central or local laboratory
- •2.History of FVIII inhibitor of = 0.6 BU as measured using the Nijmegen modification of the Bethesda assay
- •3.History of FVIII inhibitor = 1.0 BU if the subject has been tested routinely using the original Bethesda assay, or history of periods with low recovery and no response to Factor VIII treatment
- •4.Demonstrated an inability to respond to conventional doses of FVIII therapy
- •5.History of incremental recovery of Factor VIII <1.35% per IU/kg infused
- •6.Hematological disorders or blood coagulation diseases (e.g., idiopathic thrombocytopenic purpura, von Willebrand disease, etc.) other than hemophilia A
- •7.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 on physical examination and/or a history of esophageal hemorrhage or documented esophageal varices
- •8.Uncontrolled hypertension (diastolic blood pressure >100 mm Hg)
- •9.Hemoglobin < 10 g.dL
- •10.HIV disease symptoms regardless of presence of HIV antibodies
- •11.Routine administration (or planned routine administration during the course of the study), of immunosuppressive or immunomodulating drugs other than anti-retroviral therapy (e.g., steroids, beta-interferon)
- •12.Severe renal dysfunction (creatinine > 2x upper limit of normal [ULN], total bilirubin > 2x the ULN)
- •13.Liver disease (alanine aminotransferase [ALT], aspartate aminotransferase [ AST] > 3x the ULN)
- •14.History of diabetes or other metabolic disease
- •15.History of hypersensitivity or serious adverse reaction to recombinant or plasma-derived FVIII concentrate
- •16.History of pretreatment prior to the administration of FVIII products (e.g., of antihistamines)
- •17.Regular use of antifibrinolytics or medications affecting platelet function
- •18.Hypersensitivity to hamster-or mouse derived proteins
- •19.Blood transfusions within 30 days of enrollment into the study
- •20.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
- •21.Unable or unwilling to cooperate with study procedures
- •22.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
To determine the safety, effectiveness, and effect on the body of GreenGene F in previously treated patients 12 years of age or older who have severe Hemophilia A.Haemophilia AMedDRA version: 17.0Level: LLTClassification code 10018937Term: Haemophilia ASystem Organ Class: 100000004850EUCTR2012-001445-40-PLGreen Cross Corporation124
进行中（未招募）
不适用
To determine the safety, effectiveness, and effect on the body of GreenGene F in previously treated patients 12 years of age or older who have severe Hemophilia A.MedDRA version: 17.0Level: LLTClassification code 10060613Term: Hemophilia A (Factor VIII)System Organ Class: 100000004850Hemophilia AEUCTR2012-001445-40-HRGreen Cross Corporation124
未知
不适用
A-L03-L088 Other specified local infections of skin and subcutaneous tissue-L02Other specified local infections of skin and subcutaneous tissueL02L03L088PER-006-13Cubist Pharmaceuticals, Inc,
进行中（未招募）
不适用
Safety and Efficacy Study of Daptomycin in Pediatric Participants (1 to 17 Years-old) With Skin and Skin Structure InfectionsEUCTR2015-002778-19-Outside-EU/EEACubist Pharmaceuticals, Inc.389
招募中
1 期
Phase 1 study of 211At-MABG in patients with pheochromocytoma/pargangliomaPheochromocytoma, paragangliomaD010673, D010235JPRN-jRCT2021220012Shiga Tohru18