PER-058-14已完成未知
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 (MOROCTOCOG ALFA [AF-CC]) IN CHILDREN WITH HEMOPHILIA A
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- Pfizer Inc.,
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 1 至 6（—）
- 性别
- Male
入选标准
- •Males <6 years of age with moderately severe to severe hemophilia A (FVIII activity ≤ 2%), with previous FVIII replacement therapy experience (≥20 exposure days).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.4. Age <6 years at time of screening visit (study visit 1). 5. Previous experience of FVIII therapy (≥20 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.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. For more details please see the section Inclusion Criterias into the protocol.
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.Major or orthopedic surgery planned to occur within the period following the signing of the consent/assent form to the Final Study Contact (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 antiinflammatory 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. For more details please see the section Inclusion Criterias into the protocol.
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