EUCTR2010-020113-85-DE进行中（未招募）不适用
A Multicentre, Interventional, Non-randomized, Open-label, Single-group Phase III Study to evaluate Plasma-Derived Antihaemophilic Factor/von Willebrand Factor Concentrate (Biostate®) for Immune Tolerance Induction in Male Paediatric Subjects with Haemophilia A (=2%) who have Developed High-titre Antibodies to Factor VIII (Factor VIII Inhibitors). - SWIFT-ITI
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 15
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 diagnosed with haemophilia A (::;2% FVIII level in the
- •absence of factor replacement, according to their medical history).
- •2. Age 28 days to <12 years.
- •3. ITI treatment can be initiated if:
- •a. An inhibitor level of >5 and <200 BU/mL was confirmed in 2 repeated
- •tests by the central laboratory during the screening period and no
- •waiting period is required as judged by the investigator.
- •b. An inhibitor level of >5 and <200 BU/mL was confirmed in 2 repeated
- •tests by the central laboratory during the screening period and the
- •inhibitor titre decreased from the peak titre during a waiting period
- •(maximum 11 months) added at the discretion of the investigator.
- •c. A subject has pre-existing inhibitors, determined no more than 11
- •months prior to the Screening visit, which decreased from the peak titre,
- •and an inhibitor level of >5 and <200 BU/mL was confirmed in 2
- •repeated tests by the central laboratory during the screening period. A
- •waiting period could still be added if the total duration from inhibitor
- •XML File Identifier: vFDreSBztfLwGbRZGET6u4sLSvo=
- •diagnosis until start of IT! treatment (ie, including the screening period)
- •does not exceed 12 months.
- •4. The subject and/or his legally acceptable representative understand
- •the nature of the study and have given written informed consent to
- •participate in the study.
- •5. Sufficient peripheral venous access or central venous line.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 15
- •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
排除标准
- •Exclusion Criteria:
- •l.DThe subject has received IT! previously.
- •2.DSubjects with a historical peak inhibitor titre of ~200 BU/mL.
- •3.DConcomitant treatment with drugs with immunosuppressive side
- •effects (eg, systemic cortlcosteroids), azathioprine, cyclophosphamide,
- •high dose immunoglobulin or the use of a protein A column or
- •plasmapheresis and interferons.
- •4.DHigh risk of cardiovascular, cerebrovascular, or other
- •thromboembolic events (excluding catheter thrombosis) as judged by
- •the investigator.
- •5. DSubjects who are human immunodeficiency virus (HIV)-l or HIV-2
- •positive (as reported in the medical records or determined at screening).
- •6.DThe subject has evidence or a history (within the previous 12
- •months) of abuse of any drug substance, licit or illicit.
- •7.DThe subject has a known or suspected hypersensitivity or has
- •previous evidence of severe side effects to von Willebrand factor
- •(VWF)/FVIII or FVIII concentrates or human albumin.
- •S.DThe subject has participated in a clinical study or used an
- •investigational compound (eg, a new chemical entity not approved for
- •clinical use) in the past 3 months, unless the study was for haemophilia
- •A and the subject developed an inhibitor (then, a wash-out period of at
- •least 4 weeks must be applied), or is planning to enter such a study
- •during the study period.
- •9.DSubjects or legal guardians/ representatives with suspected inability
- •(eg, language problems) or unwillingness to comply with study
- •procedures.
- •10.DThe subject has an acute or chronic medical condition other than
- •haemophilia A, which may, in the opinion of the investigator, affect the
- •conduct of the study.
- •l1.DMental condition rendering the subject (or the subject's legally
- •acceptable representative) unable to understand the nature, scope and
- •possible consequences of the study).
- •12.DAny condition that is likely to interfere with evaluation of the
- •investigational medicinal product (IMP) or satisfactory conduct of the
- •13.DEmployee at the study site, or spouse/partner or relative of the
- •investigator or subinvestigators.
- •Study Product, Dose, and Mode of Administration:
- •The IMP Biostate will be intravenously (I.v.) administered at a daily dose
- •of 200 international units (IU)/kg body weight (b.w.), preferably split
- •into 2 doses of 100 IU/kg b.w. per day.
- •For subjects with an undetectable inhibitor titre «0.6 BU/mL) at 2
- •consecutive assessments, tested at intervals of 2 weeks (±3 days), and
- •normal recovery (~66% of predicted) for 6-S weeks, the daily Biostate
- •dose will be reduced by 20 IU/kg b.w. (ie, by 10% of the initial daily ITI
- •dose), if possible, every 2-4 weeks down to a dose of 100 IU/kg b.w.,
- •provided the recovery remains normal during that time (assessed
- •After further gradual reduction of the dose and extension of the administration interval (at the discretion of the investigator), Biostate
- •will be administered as prophylaxis at a daily dose of 50 IU/kg b.w, on 3
- •days per week (about every second day).
- •Any daily dose'~100IU/kg b.w. should preferably be evenly split into 2
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