The ADVANCE in Japan

JRCT ID: jRCT1030190046

Registered date:28/06/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Haemophilia
• Date of first enrollment: 23/02/2019
• Target sample size: 600
• Study type: Observational
• Intervention(s): NA

Outcome(s)

• Primary Outcome: The principal objectives of the ADVANCE Study will be to determine the incidence rates of cardiovascular events.

Secondary Outcome

To track the rates of anti-coagulation usage and death in PWH with CVD
To compare the incidences and rates of death from CVD between PWH and a general male population
To compare the incidence of CVD with the expected rates calculated from the CVD risk scores recorded at baseline
To describe the incidences and rates of treatment for other comorbidities
To compare the rates of comorbidities between PWH and a general male population
To describe the management and outcomes
To track the emergence of inhibitors over time in older PWH and their influence on cardiovascular events and the management of such events and
To identify the causes of death in older PWH

Key inclusion & exclusion criteria

• Age minimum: >= 40age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Mild, moderate or severe congenital Hemophilia A or B
Age 40 years or over
If informed consent is required by the regulations of each facility, consent must be obtained.

Exclude criteria

Acquired hemophilia
Other coagulation disorder
Patients with Factor VIII and Factor IX activity >40% at the time of diagnosis
Under 40 years old
If informed consent is required by the regulations of each facility, it is not possible to obtain it.
If informed consent is not required, if the patient requests that the information cannot be provided

Related Information

• Primary Sponsor: Nagao Azusa
• Source(s) of Monetary Support: Bayer Yakuhin, Ltd.