EUCTR2006-005575-17-ES进行中（未招募）1 期
An Open-Label Study to Evaluate Prophylaxis Treatment, and to Characterize the , Efficacy, Safety and Pharmacokinetics of B Domain Deleted Recombinant Factor VIII Albumin Free (ReFacto AF) in Children With Hemophilia A Estudio abierto para evaluar el tratamiento profiláctico y para caracterizar la eficacia, la seguridad y la farmacocinética del factor VIII recombinante con delección del dominio B sin albúmina (ReFacto® AF) en niños con hemofilia A - N/A
Wyeth Research Division of Wyeth Pharmaceuticals Inc.0 个研究点目标入组 65 人开始时间: 2007年11月28日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 65
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
- •1. Male subjects with moderately severe to severe hemophilia A (FVIII:C = 2%) by both the local laboratory and the central laboratory at screening.
- •2. A negative FVIII inhibitor by both the local laboratory and the central laboratory at screening (for local laboratory, a Bethesda inhibitor titer less than the upper limit of normal [ULN] for the laboratory performing the assay and is not reported to be = 0.6 Bethesda Units [BU]/mL; for central laboratory, Bethesda inhibitor titer < 0.6 BU/mL by Nijmegen assay).
- •3. A medical history negative for a past FVIII inhibitor (see Protocol Definitions).
- •4. Age < 6 years at time of screening visit (study visit 1).
- •5. Previous experience of FVIII therapy (= 50 exposure days to any FVIII replacement product).
- •6. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 5.0 × ULN, and bilirubin = 2 mg/dL (< 35 µmol/L).
- •7. Serum albumin = the lower limit of normal (LLN).
- •8. Serum creatinine = 1.25 × ULN.
- •9. Platelet count = 100,000/µL.
- •10. Absolute CD4 count > 400/µL.
- •11. Prothrombin time (PT) = 1.25 × ULN, or international normalized ratio (INR) = 1.5
- •12. The subject is not receiving treatment for HIV or hepatitis infection, or the subject is on a stable antiviral regimen at the time of signing the consent/assent form (ie, stable dosing for at least 3 months before signing the consent/assent form).
- •13. The subject is able to comply with the mandatory 72-hour FVIII washout preceding each FVIII:C and FVIII inhibitor assessment during the study
- •Additionnal Criteria for subjects participating in the PK and recvery assessments:
- •1. Male subjects as described immediately above except they must have a FVIII:C of =< 1% confirmed by the central laboratory screening test
- •2. Age < 6 years at time of PK assessment (study visit 2).
- •3. The subject's size is sufficient to permit PK-related phlebotomy.
- •4. The subject is able to comply with the procedures conducted during the PK and recovery assessment, including a mandatory 72-hour washout period preceding the PK and Recovery assessments.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •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
- •1. A history of FVIII inhibitor (clinical or laboratory-based assessment). For laboratory assessments, any measured Bethesda inhibitor titer = 0.6 BU/mL, regardless of the laboratory normal range, or any measured Bethesda inhibitor titer greater than the ULN for the laboratory performing the assay.
- •2. Presence of a bleeding disorder in addition to hemophilia A.
- •3. Treatment with any investigational drug or device within 30 days before the time of signing the consent/assent form.
- •4. Surgery planned to occur within a 26-month period following the signing of the consent/assent form (ie, during the course of the study).
- •5. Regular (eg, daily, every other day) use of antifibrinolytic agents or medications known to influence platelet function such as aspirin or certain nonsteroidal anti-inflammatory drugs (NSAIDs).
- •6. Regular, concomitant therapy with immunomodulating drugs (eg, intravenous immunoglobulin [IVIG], routine systemic corticosteroids).
- •7. Known hypersensitivity to hamster protein.
- •8. Any condition(s) that compromises the subject’s ability to comply with and/or perform study-related activities or that poses a clinical contraindication to study participation (these conditions include, but are not limited to, inadequate medical history to assure study eligibility; inability to properly store study drug; expectation of poor compliance in study related documentation).
- •9. Unwilling or unable to follow the terms of the protocol.
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