EUCTR2008-003855-65-PL进行中（未招募）1 期
FEIBA NF: A PROSPECTIVE, OPEN-LABEL, RANDOMIZED, PARALLEL STUDY TO EVALUATE EFFICACY AND SAFETY OF PROPHYLACTIC VERSUS ON-DEMAND TREATMENT IN SUBJECTS WITH HEMOPHILIA A OR B AND A HIGH TITER INHIBITOR
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
- 34
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
- •- Signed and dated informed consent form by the subject or the subject’s legally authorized representative
- •- The subject is = 4 to = 65 years of age
- •- The subject has Karnofsky performance score of = 60
- •- Hemophilia A and B of any severity, with documented history of high-titer inhibitor (>5BU) for at least 12 months; or, if inhibitor titer is = 5 BU, and the subject is refractory with increased dosing of either FVIII or FIX, as demonstrated from the subject’s medical history
- •- Currently being treated on an on-demand basis for treatment of bleeding episodes
- •- Adequate venous access, with or without central venous device
- •- >/= 12 bleeding episodes in the past 12 months, based on medical history
- •- Competent in home treatment and infusion therapy
- •- Currently using bypassing agents (APCCs, or rFVIIa) for treatment of bleeding episodes
- •- HCV-, either by antibody testing or PCR; or HCV+ with stable hepatic disease
- •- HIV-, or HIV+ with stable disease and CD4 count > 200 cells/mm3 at screening
- •- Female subject of childbearing potential, presents with a negative serum pregnancy test, and agrees to employ adequate birth control measures for the duration of the study
- •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
- •- Currently receiving immune tolerance induction (ITI)
- •- Currently on regular prophylactic therapy to prevent bleeding episodes
- •- Clinically symptomatic liver disease (e.g. diagnosis of cirrhosis, [liver biopsy confirmed], portal vein hypertension, ascites, prothrombin time (PT) 5 seconds above upper limit of normal)
- •- Platelet count < 100,000/ml
- •- Planned elective surgery during participation in this study
- •- Subject is currently participating in another clinical study and has received an investigational product or device within 30 days prior to study entry
- •- Planned use of pegylated and non-pegylated alpha-interferon with or without ribavarin for HCV infected subjects or planned use of a protease inhibitor for HIV infected subjects. Subjects currently taking any of these medications for a 30-day course are eligible
- •- Clinically significant increase in D-dimer levels from historical baseline and/or associated with cronic liver disease or clinically evident thromboembolic event
- •- Known hypersensitivity to AICCs
- •- Currently treated with a systemic immunomodulating drug
- •- Prior history of thromboembolic event: acute myocardial infarction, deep vein thrombosis, pulmonary embolism
- •- Diagnosis of advanced atherosclerosis, malignancy and/or other diseases that may increase the subject’s risk of thromboembolic complications
- •- Clinically significant medical, psychiatric, or cognitive illness, or recreational drug/alcohol use that, in the opinion of the investigator, would affect subject safety or compliance
研究者
相似试验
进行中（未招募）
1 期
FEIBA NF: A prospective, open-label, randomized, parallel study to evaluate efficacy and safety of prophylactic versus on-demand treatment in subjects with hemophilia A or B and a high titer inhibitor - FEIBA NF Prophylaxis StudyHemophilia A or B and a high titer inhibitorMedDRA version: 9.1 Level: LLT Classification code 10056492 Term: Haemophilia A with anti factor VIIIMedDRA version: 9.1 Level: LLT Classification code 10056494 Term: Haemophilia B with anti factor IXEUCTR2008-003855-65-FRBaxter Innovations GmbH36
进行中（未招募）
不适用
FEIBA NF: A prospective, open-label, randomized, parallel study to evaluate efficacy and safety of prophylactic versus on-demand treatment in subjects with hemophilia A or B and a high titer inhibitor - FEIBA NF Prophylaxis StudyEUCTR2008-003855-65-BGBaxter Innovations GmbH34
进行中（未招募）
不适用
FEIBA NF: STUDIO PROSPETTICO IN APERTO, RANDOMIZZATO, A GRUPPI PARALLELI, VOLTO A VALUTARE EFFICACIA E SICUREZZA DEL TRATTAMENTO PROFILATTICO VS QUELLO AL BISOGNO IN PAZIENTI AFFETTI DA EMOFILIA A O B E CON INIBITORI A TITOLO ELEVATO - FEIBA NF Prophylaxis StudyHemophilia A or B and a high titer inhibitorMedDRA version: 9.1Level: LLTClassification code 10063563EUCTR2008-003855-65-ITBAXTER INNOVATIONS GMBH34
尚未招募
2 期
A clinical trial of ATTATHI CHOORANAM in the management of RAKTHA SOORAI VAAYU (POLY CYSTIC OVARIAN SYNDROME)CTRI/2019/05/019119Government Siddha Medical College and Hospital
进行中（未招募）
不适用
PRO-FEIBA. Asetelma on selkeä etenevä satunnaistettu kaksisuuntainen tutkimus aktivoitujen hyytymistekijöiden (aPCC, activated prothrombin complex concentrate) vaikutuksesta vaikeaa A hemofiliaa sairastavien miesten taudinkulkuun, elämänlaatuun ja terveystaloudellisiin näkökohtiin.A-hemofiliaEUCTR2006-001217-15-FIassila Riitta42