TAK-577-4005: Estimating Risk of Selected Adverse Events in Patients with Von Willebrand Disease Treated With VEYVONDI® (Vonicog Alfa; Recombinant Von Willebrand Factor)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/48320
• EU PAS number:
  EUPAS45617
• Study ID:
  48320
• Official title and acronym:
  TAK-577-4005: Estimating Risk of Selected Adverse Events in Patients with Von Willebrand Disease Treated With VEYVONDI® (Vonicog Alfa; Recombinant Von Willebrand Factor)
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Denmark

  France

  Germany

  Netherlands

  Norway

  Sweden

  United Kingdom (Northern Ireland)
• Study description:
  The main aim of this study is to estimate the risks of certain adverse events in adults with Von Willebrand Disease treated with VEYVONDI. No study medicines will be provided to participants in this study. Data from medical records of participants diagnosed with Von Willebrand Disease and treated with VEYVONDI will be evaluated during this study.
• Study status:
  Finalised

Research institutions and networks

Institutions

Takeda

Study timelines

Date when funding contract was signed

Planned: 23/09/2021

Actual: 23/09/2021

Study start date

Planned: 01/05/2022

Actual: 08/06/2022

Date of final study report

Planned: 30/12/2022

Actual: 04/12/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Takeda

Study protocol

Initial protocol

tak-577-4005-protocol-original_redact

Updated protocol

TAK-577-4005-clinical-study-protocol-redact.pdf

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)

Other study registration identification numbers and links

ClinicalTrials.gov Identifier: NCT05265078

https://clinicaltrials.gov/ct2/show/NCT05265078,,https://clinicaltrials.takeda…