An Observational Study of Vonicog Alfa (rVWF) in Pediatric Participants With Von Willebrand Disease (vWD)

Condition(s) studied

Investigational drug(s) / intervention(s)

vonicog alfa (rVWF): rVWF administered by intravenous injection.

Study summary

This study is conducted in Japan of vonicog alfa (rVWF) used to treat pediatric participants with Von Willebrand Disease (vWD).

The main aim of the study is to evaluate adverse drug reaction and effectiveness of vonicog alfa (rVWF).

During the study, pediatric participants with vWD will be administered with rVWF under routine normal practice. The investigators will evaluate adverse events due to rVWF for 1 year from the start of drug administration.

The study sponsor will not be involved in how the participants are administered but will be recorded what happens during the study.

Eligibility

Primary outcome measure(s)

• Number of Participants who Experience at Least One Adverse Drug Reactions (ADRs) — Up to 1 year
  Adverse Event (AE) refers to any undesirable medical occurrence in a patient administered a drug, regardless of causal relationship. This includes any unfavorable or unintended sign (including abnormal laboratory findings), symptom, or disease occurring during administration, regardless of causal relationship. Adverse drug reaction (ADR) refers to AE related to administered drug.

Trial sites (1)

More Takeda trials in Japan

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