Prospective, Open-Label, Multi-Center, Phase III Clinical Study To Investigate The Efficacy And Safety Of Human Factor VWF/VIII Concentrate (Wilate) In Subjects With Inherited Type 3 Von Willebrand Disease (VWD) Who Undergo Major Surgical Procedures. - WIL-24

OCTAPHARMA AG0 个研究点目标入组 41 人开始时间: 2012年3月7日最近更新: 2014年5月19日

适应症

试验速览

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•Male and female subjects who are at least 6 years of age.
•2. Diagnosed with Type 3 VWD where VWF:RCo and VWF:Ag are <1% or below detection limit of the assay at screening or the subject has a diagnosis of Type 3 VWD and a history of VWF:RCo and/or VWF:Ag are < 1% or below detection limit of the assay documented in their medical notes at enrolment.
•3. Require therapy with a VWF product to treat any potential major surgical procedure.
•4. Negative for anti-human immunodeficiency virus (HIV); if positive, viral load <200 particles/µL or <400,000 copies/mL and CD4+ count > 200/µL.
•5. The subject and/or their legally acceptable representative understands the nature of the study, gives written informed consent to participate in the study and is willing and able to comply with the protocol.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 3
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 23
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 15

•1. Known coagulation disorder other than congenital Type 3 VWD.
•2. Any VWF containing product administered within 3 days prior to the screening visit.
•3. Any subject where it is planned to infuse the investigational product via continuous infusion.
•4. Have a known history of, or are suspected to have VWF or FVIII inhibitors.
•5. Emergency surgery or any surgery with a degree of urgency not permitting completion of baseline assessment required by the study protocol.
•6. Suffering an acute or chronic medical condition, other than VWD, which may in the opinion of the Investigator affect the conduct of the study.
•7. Subjects with active hepatic disease (ALT or AST levels > 5 times the upper limit of normal)
•8. Have a known or suspected hypersensitivity or previous evidence of severe side effects to Wilate or other VWF/FVIII concentrates.
•9. Subjects receiving immune-modulating drugs (other than anti-retroviral chemotherapy) such as alpha-interferon, prednisone (equivalent to >10 mg/day), or similar drugs at study start.
•10. Pregnant women within the first 20 weeks of gestation.
•11. Subjects having evidence or a history (within the previous 12 months) of abuse of any drug substance, licit or illicit.
•12. Participation in another interventional clinical study currently or during the past 4 weeks.

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