Clinical trial

A Multi-centre, Open-label, Single-arm, Non-interventional Post-marketing Study to Investigate Safety and Clinical Parameters of Alhemo® Under Routine Clinical Practice in Japan

Name

NN7415-7557

Description

The purpose of the study is to investigate the safety and effectiveness of Alhemo® in all participants under real-world clinical practice in Japan. Participants will get Alhemo® as prescribed by the study doctor. The study will last for about 2 years.

Trial arms

Trial start

2024-04-30

Estimated PCD

2030-04-30

Trial end

2030-04-30

Treatment

Concizumab

Participants will be treated with commercially available Alhemo (Concizumab) according to routine clinical practice at the discretion of the treating physician. The decision to initiate treatment with commercially available Concizumab has been made by the participant/ legally acceptable representative (LAR) and the treating physician before and independently from the decision to include the participant in this study.

Arms:

Concizumab

Other names:

Alhemo

Size

Primary endpoint

Number of adverse reaction (AR)

From baseline (week 0) to end of study (week 104)

Eligibility criteria

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 Alhemo® has been made by the patient/LAR and the treating physician before and independently from the decision to include the patient in this study * Male or female patients, regardless of age * Diagnosis with HAwI/HBwI Exclusion Criteria: - Previous participation in this study. Participation is defined as having given informed consent in this study

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'CASE_ONLY', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 23, 'type': 'ESTIMATED'}}

Updated at

2024-04-01

1 organization

1 product

2 indications

Product

Indication

Indication

Organization