Post-Marketing Surveillance (Use-results Surveillance) With Esperoct®

Novo Nordisk

Status: Completed

Conditions: Haemophilia A

Treatments: Drug: Turoctocog alfa pegol

Study type: Observational

Funder types: Industry

Identifiers

NCT04334057

NN7088-4484

U1111-1216-4626 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to assess the safety and effectiveness of Esperoct® for long-term routine use in patients with Haemophilia A. Participants will get Esperoct® as prescribed by their doctor. The study will last for about 2 years for each participant.

Enrollment: 23 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
• The decision to initiate treatment with commercially available Esperoct® has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study.
• Diagnosis of haemophilia A in males or females, no age limitation.
• New patients who have not previously been exposed to Esperoct®.

Exclusion criteria

• Previous participation in this study. Participation is defined as having given informed consent in this study.
• Known or suspected hypersensitivity to study product or related products.
• Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.

Trial design

23 participants in 1 patient group

Patients with haemophilia A

Description:

New patients who have not previously been exposed to Esperoct® (Turoctocog alfa pegol or N8-GP in clinical trials) are eligible for this study.

Treatment:

Drug: Turoctocog alfa pegol