Prospective, Open-Label, Multi-Center, Phase III Clinical Study To Investigate The Efficacy And Safety Of Human Factor VWF/VIII Concentrate (Wilateï¿½) In Subjects With Inherited Von Willebrand Disease (VWD) Who Undergo Surgical Procedures - Nil

Octapharma AG0 个研究点目标入组 41 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1. Male and female subjects who are at least 6 years of age.
•2. Diagnosed with congenital VWD (any type) where VWF:RCo is below 40% at screening or the subject has a diagnosis of Type 1, 2 or 3 VWD and a history of VWF:RCo below 40% documented in their medical notes at enrolment.
•3. Require therapy with a VWF product to treat any potential surgical procedure.
•4. Negative for anti-human immunodeficiency virus (HIV); if positive, viral load less than 200 particles/microlitre or less than 400,000 copies/mL and CD4+ count greater than 200/microlitre.
•5. The subject and/or 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.

•1. Known coagulation disorder other than congenital 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 gretare than 5 times the upper limit of normal)
•8. Have a known or suspected hypersensitivity or previous evidence of severe side effects to Wilateï¿½ 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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