A multicenter study to describe the immunogenic epitope(s) of factor VIII in previously treated patients with congenital hemophilia A who develop de novo factor VIII inhibitors while receiving factor VIII infusion therapy - N/A

Wyeth Pharmaceuticals0 个研究点目标入组 27 人开始时间: 2005年7月4日最近更新: 2012年5月1日

适应症

试验速览

暂无简介。

•Inhibitor positive hemophilia A patients:
•1. Written informed consent or assent, as applicable.
•2. Patients with moderate or severe congenital hemophilia A (FVIII:C <5%).
•3. Patients with at least one positive de novo* inhibitor result (> the upper limit of normal as defined by the laboratory performing the assay), attributable by the Investigator to the patient's current FVIII product, at the time of the study visit and a positive inhibitor result confirmed by the central laboratory.
•4. Patients with exposure to at least two different FVIII products during their lifetime.
•5. Patients with > 50 cumulative ED to FVIII products.
•6. Patients able to comply with a 72-hour FVIII washout period.
•*de novo inhibitor is defined as no known history of FVIII inhibitor titer.
•Comparison Group (inhibitor-free patients):
•1. Written informed consent / assent, as applicable.
•2. Patients with moderate or severe congenital hemophilia A (FVIII:C <5%).
•3. Patients with exposure to at least two different FVIII products during their lifetime.
•4. Patients with >50 cumulative exposure to FVIII products.
•5. Documented negative FVIII BIA at screening (<0.6 BU).
•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) yes
•F.1.3.1 Number of subjects for this age range

•Inhibitor positive hemophilia A patients:
•1. Patients with a negative FVIII inhibitor result (=the upper limit of normal as defined by the laboratory performing the assay) at the study visit.
•2. Patients with known history of an inhibitor (> the upper limit of normal as defined by the laboratory performing the assay) prior to their current inhibitor.
•3. Patients who have not had at least 1 FVIII BIA performed during the last 5 years prior to their visit for this study.
•4. Patients who have received FVIII immune tolerance therapy at any time.
•5. Patients, who as of the study visit, have taken only one FVIII product during their lifetime.
•6. For patients whose current inhibitor is attributable to treatment with ReFacto; treatment with ReFacto prior to their previous product. In other words, patients who were previously treated with ReFacto, then switched to another product, then switched back to ReFacto.
•7. Patients with immune disorders (e.g., HIV, myeloma, lymphoma).
•Comparison group (inhibitor-free patients):
•1. Patients with a positive FVIII inhibitor result (> the upper limit of normal as defined by the laboratory performing the assay) at the time of the study visit.
•2. Patients with a prior history of FVIII inhibitor (> the upper limit of normal as defined by the laboratory performing the assay).
•3. Patients with immune disorders (e.g., HIV, myeloma, lymphoma).

发起方

Wyeth Pharmaceuticals