Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

A Phase 3 Open-label, Multicenter Study of the Safety, Efficacy, and Pharmacokinetics of Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein (rFVIIIFc-VWF-XTEN; BIVV001) in Previously Treated Pediatric Patients <12 Years of Age With Severe Hemophilia A

X
Trial Profile

A Phase 3 Open-label, Multicenter Study of the Safety, Efficacy, and Pharmacokinetics of Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein (rFVIIIFc-VWF-XTEN; BIVV001) in Previously Treated Pediatric Patients <12 Years of Age With Severe Hemophilia A

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 30 Apr 2024

Price : $35 *
  • Adis is an information provider.
  • Final gross price and currency may vary according to local VAT and billing address.
  • Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
  • A link to download a PDF version of the trial profile will be included in your email receipt.

At a glance

  • Drugs Efanesoctocog alfa (Primary)
  • Indications Haemophilia A
  • Focus Adverse reactions; Registrational
  • Acronyms XTEND-Kids; XTEND-Kids pediatric
  • Sponsors Bioverativ
  • Most Recent Events

    • 26 Apr 2024 According to Sobi media release, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion recommending approval of efanesoctocog alfa, for the treatment and prevention of bleeds and perioperative prophylaxis in haemophilia A. The recommendation from the CHMP is based on the results from the XTEND-1 and XTEND-Kids studies
    • 31 Jan 2024 According to Sobi media release, Quality of Life in children with Haemophilia A and secondary analysis data to be presented at EAHAD 2024.
    • 12 Dec 2023 Results (n=74) post hoc analyses of once-weekly efanesoctocog alfa well tolerated and provided effective treatment of and protection from bleeds in previously treated patients less than 12 years old with severe hemophilia A, presented at the 65th American Society of Hematology Annual Meeting and Exposition
Subscriber content

You need to be a logged in subscriber to view this content.

If your organization has a subscription then there are several options available to help you access AdisInsight, even while working remotely.

  • IP authentication when working within your organization’s network.
  • with username/password or try via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days.
  • Contact us at AsktheExpert.AdisInsight@springer.com for assistance.

If your organization does not have a subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Buy a PDF version of the profile.
  • Request a free trial
Back to top