EUCTR2019-002854-22-BG进行中（未招募）1 期
A RANDOMIZED, MULTICENTER, DOUBLE BLIND CLINICAL TRIALCOMPARING PHARMACODYNAMIC, PHARMACOKINETIC AND SAFETY OFA BIOSIMILAR EPTACOG ALFA (ARYOSEVEN) AND NOVOSEVEN®, INPATIENTS WITH HAEMOPHILIA A OR B WITH INHIBITORS
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 48
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
- Male
入选标准
- •- Confirmed diagnosis of congenital haemophilia A or B with inhibitors to FVIII or FIX titer
- •>5 Bethesda Units [BU]
- •- with > 2 episodes of bleeding/year requiring treatment with FVII infusions, non in bleeding
- •- male subjects
- •- adult and children (>12 years)
- •- Patients to be enrolled must also provide voluntary written informed consent to the protocol
- •to be eligible for the study. For minor patients, parent/legal guardian will provide
- •consent and, when possible, patient assent will also be obtained. For compromised patients,
- •their designated proxy must provide informed consent.
- •- For the PK/PD phase, patients will be hospitalized at time of study medication
- •administration for plasma sampling (2 times during the study).
- •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 48
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Any other type of congenital or acquired coagulopathy, such as: liver disease (hepatitis),
- •vitamin k deficiency, uremia, malignancy.
- •- Antibodies against Factor VII
- •- Ongoing bleeding prophylaxis regimens with Novoseven or planned to occur during the
- •- Patients who have received routine (prophylactic) treatment with rFVIIa in the period
- •between screening visit (visit 1) and visit 2 of this study (first dose administration)
- •- Platelet count less than 100.000 platelets/mcL (at screening visit)
- •- Any clinical sign or known history of arterial thrombotic event or deep venous- thrombosis
- •or pulmonary embolism
- •- HIV positive with current CD4+ count of less than 200/µL
- •- Liver cirrhosis
- •- Factor VIII/IX immune tolerance induction regimen planned to occur during the trial
- •- Known hypersensitivity to the study medication
- •- Parallel participation in another experimental drug trial.
- •- Parallel participation in another marketed drug trial that may affect the primary end point of
研究者
相似试验
进行中（未招募）
1 期
Clinical study to assess the efficacy and safety of Ciprofloxacin plus Fluocinolone otic solution compared to Ciprofloxacin otic solution and to Fluocinolone Otic solution in the treatment of ear infection in pediatric patients with tympanostomy tubes.Acute Otitis Media with Tympanostomy Tubes (AOMT) in Pediatric PatientsMedDRA version: 14.0Level: PTClassification code 10033079Term: Otitis media acuteSystem Organ Class: 10021881 - Infections and infestationsEUCTR2010-023239-40-ESaboratorios SALVAT, S.A.331
进行中（未招募）
不适用
Clinical study to assess the efficacy and safety of Ciprofloxacin plus Fluocinolone otic solution compared to Ciprofloxacin otic solution and to Fluocinolone Otic solution in the treatment of ear infection in pediatric patients with tympanostomy tubes.Acute Otitis Media with Tympanostomy Tubes (AOMT) in Pediatric PatientsMedDRA version: 14.1Level: PTClassification code 10033079Term: Otitis media acuteSystem Organ Class: 10021881 - Infections and infestationsEUCTR2010-023239-40-SEaboratorios SALVAT, S.A.330
进行中（未招募）
不适用
Clinical study to assess the efficacy and safety of Ciprofloxacin plus Fluocinolone otic solution compared to Ciprofloxacin otic solution and to Fluocinolone Otic solution in the treatment of ear infection in pediatric patients with tympanostomy tubes.Acute Otitis Media with Tympanostomy Tubes (AOMT) in Pediatric PatientsMedDRA version: 14.1Level: PTClassification code 10033079Term: Otitis media acuteSystem Organ Class: 10021881 - Infections and infestationsEUCTR2010-023238-22-SEaboratorios SALVAT, S.A.330
进行中（未招募）
不适用
Clinical study to assess the efficacy and safety of Ciprofloxacin plus Fluocinolone otic solution compared to Ciprofloxacin otic solution and to Fluocinolone Otic solution in the treatment of ear infection in pediatric patients with tympanostomy tubes.Acute Otitis Media with Tympanostomy Tubes (AOMT) in Pediatric PatientsMedDRA version: 14.1Level: PTClassification code 10033079Term: Otitis media acuteSystem Organ Class: 10021881 - Infections and infestationsEUCTR2010-023239-40-FIaboratorios SALVAT, S.A.330
进行中（未招募）
不适用
Clinical study to assess the efficacy and safety of Ciprofloxacin plus Fluocinolone otic solution compared to Ciprofloxacin otic solution and to Fluocinolone Otic solution in the treatment of ear infection in pediatric patients with tympanostomy tubes.Acute Otitis Media with Tympanostomy Tubes (AOMT) in Pediatric PatientsMedDRA version: 14.1Level: PTClassification code 10033079Term: Otitis media acuteSystem Organ Class: 10021881 - Infections and infestationsEUCTR2010-023238-22-FIaboratorios SALVAT, S.A.330