EUCTR2008-003960-20-IT进行中（未招募）不适用
Open-label, non-Controlled Trial on Efficacy and Safety in Prevention and On-demand Treatment of Bleeding Episodes in Previously Treated Patients of N8 in with Haemophilia A.Sub-trial Efficacy and Safety of N8 in Prevention and Treatment of Bleeding during Surgical Procedures in Patients with Haemophilia A - ND
OVO NORDISK0 个研究点目标入组 140 人开始时间: 2009年6月18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
- 140
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
- •Part A: 1.Completion of the phase 1 PK trial NN7008-3522. 2.Informed consent obtained prior to any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject. 3. Male subjects with the diagnosis of severe (baseline FVIII<=1%) haemophilia A from age 12 to 56 years having a with a weight range of 20-120 kg.4. Willing to undergo a bleeding preventive regimen of 75 exposure days. 5. Non-bleeding state (i.e. no clinical manifestation of active bleed) at the time of administration of trial product for measurement of recovery in relation to administration of the first dose and the PK session. 6. Documented history of at least 150 exposure days to any other FVIII products (prevention or on-demand treatment. 7.No history of FVIII inhibitors >=0.6 BU/mL measured regularly since the first treatment of haemophilia A prior to entering the trial or the time period should cover at least 8 years. 8.No detectable inhibitors to FVIII (<0.6 BU/mL) (as assessed by central laboratory at the time of screening9. 9.Hepatitis C Virus (HCV) seronegative or if HCV seropositive, viral load less than 200 particles/microL measured by PCR. 10.Lupus anticoagulant negative. 11. HIV-1 seronegative or if HIV-1 seropositive, CD4+ lymphocyte count >=200/microL. Part B: 1.Informed consent obtained prior to any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject. 2. Male subjects with the diagnosis of severe (baseline FVIII<=1%) haemophilia A from age 12 to 56 years having a with a weight range of 20-120kg.3. Willing to undergo a bleeding preventive regimen of 75 exposure days. 4. Non-bleeding state (i.e. no clinical manifestation of active bleed) at the time of administration of trial product for measurement of recovery in relation to administration of the first dose and the PK session. 5. Documented history of at least 150 exposure days to any other FVIII products (prevention or on-demand treatment. 6.No history of FVIII inhibitors >=0.6 BU/mL measured regularly since the first treatment of haemophilia A prior to entering the trial or the time period should cover ar least 8 years. 7.No detectable inhibitors to FVIII (<0.6 BU/mL) (as assessed by central laboratory at the time of screening 8.Hepatitis C Virus (HCV) seronegative or if HCV seropositive, viral load less than 200 particles/microL measured by PCR. 9.Lupus anticoagulant negative. 10. HIV-1 seronegative or if HIV-1 seropositive, CD4+ lymphocyte count >=200/microL. Part C 1.Scheduled to undergo major or minor surgical procedures 2.Surgical procedure requiring at least 6 days of infusion of N8 concentrate post-operatively. Subjects will only participate in Part C when they have been included in either Part A or Part B and have received at least one dose of trial product (N8).
- •Are the trial subjects under 18? yes
- •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
- •Part A and Part B 1.Subjects on Immune Tolerance Treatment (ITT) regimens. 2.Pharmaceutical treatment of a mild and moderate bleeding episode within one week prior to first dose. 3.Pharmaceutical treatment of a severe bleeding episode within one week prior to first dose. 4.Known pseudo-tumours 5.Platelet count <50,000 platelets/ microL (based on medical records) at trial entry. 6. Severe current hepatic dysfunction or severe hepatic disease during the last 12 months. 7.ALAT > than 4 times of the upper limit of normal reference range (as defined by local laboratory ranges). 8.Septicaemia, e.g. febrile illness within 5 days prior to trial product administration. 9.Current dialysis therapy. 10.Creatinine levels 50% above normal level (according to central laboratory range). 11.Congenital or acquired coagulation disorders other than haemophilia A 12.Previous arterial thrombotic events (Myocardial Infarction and Intra Cranial Thrombosis) (as defined by medical records).13.Known or suspected allergy to trial product (N8) or related products. 14.Surgery within one month prior to first administration of trial product (catheter, stents, ports, and dental extractions do not count as surgeries, i.e. they will not exclude the subject). 15.Use of Coagulation Factors: FVIII concentrates or other FVIII containing products within four days prior to first administration of trial product. 16.Use of Anticoagulants: Heparin, vitamin-K antagonists, and direct thrombin inhibitors one week prior to first administration of trial product. 17.Use of non-prescribed opiate substances. 18. Regular use of cannabis (only for subjects in Part A) 19.Use of platelet inhibitors including NSAID one week prior to first administration of trial product. 20.The receipt of any investigational drug within 30 days prior to administration of trial product except subjects who have completed NN7008-3522. 21.Previous participation in the current trial (defined as withdrawal) or withdrawn subjects from NN7008-3522 after administration of trial product. 22.Any disease or condition which, according to the Investigator?s judgement, could imply a potential hazard to the subject, interfere with the trial participation or trial outcome. 23.Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
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