ADYNOVATE Drug Use-Results Survey

Takeda

Status: Completed

Conditions: Hemophilia A

Treatments: Biological: ADYNOVATE

Study type: Observational

Funder types: Industry

Identifiers

NCT03169972

261601

Details and patient eligibility

About

The purpose of this survey is to understand the following items in the actual clinical use of ADYNOVATE in patients:

1. Unexpected adverse drug reactions
2. Occurrence of adverse drug reactions in the actual clinical use
3. Factors that may affect safety and efficacy
4. Occurrence of Factor VIII inhibitor development in patients with coagulation factor VIII deficiency (hereinafter hemophilia A)
5. Safety and efficacy for hemophilia A patients who received routine prophylactic therapy and on-demand therapy

Enrollment: 135 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Hemophilia A patients who receive ADYNOVATE, including previously treated patients with Factor VIII deficiency (PTPs), and previously untreated patients with Factor VIII deficiency (PUPs) who are treated with ADYNOVATE.

Exclusion criteria

• Patients not administered ADYNOVATE.

Trial design

135 participants in 2 patient groups

Previously treated patients (PTPs)

Description:

PTPs: patients who had 4 or more days to other Factor VIII (FVIII) products

Treatment:

Biological: ADYNOVATE

Previously untreated patients (PUPs)

Description:

PUPs: patients who had 3 or less previous exposure days to other products

Treatment:

Biological: ADYNOVATE