Post-Marketing Surveillance (All Case Surveillance) on Treatment With Alhemo® in Patients With Haemophilia A or Haemophilia B With Inhibitors

Haemophilia A Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06285071
• Other study ID #: NN7415-7557
• Secondary ID: U1111-1274-4740
• Status: Enrolling by invitation
• Start date: April 30, 2024
• Est. completion date: April 30, 2030

Study information

• Verified date: March 2024
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 23
• Est. completion date: April 30, 2030
• Est. primary completion date: April 30, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Haemophilia A
• Haemophilia B
• Hemophilia A
• Hemophilia B

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Japan	Novo Nordisk Investigational Site	Toshima	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of adverse reaction (AR)	Measured as count of ARs.	From baseline (week 0) to end of study (week 104)
Secondary	Number of serious adverse reaction (SAR)	Measured as count of SARs.	From baseline (week 0) to end of study (week 104)
Secondary	Number of serious adverse event (SAE)	Measured as count of SAEs.	From baseline (week 0) to end of study (week 104)
Secondary	Number of thromboembolic adverse event (AE)	Measured as count of thromboembolic AEs.	From baseline (week 0) to end of study (week 104)
Secondary	Number of shock/anaphylaxis AE	Measured as count of shock/anaphylaxis AEs.	From baseline (week 0) to end of study (week 104)
Secondary	Number of treated spontaneous and traumatic bleeding episodes	Measured as count of bleeding episodes.	From baseline (week 0) to end of study (week 104)
Secondary	Number of treated spontaneous and traumatic target joint bleeding episodes	Measured as count of bleeding episodes.	From baseline (week 0) to end of study (week 104)
Secondary	Number of all treatment requiring bleeding episode	Measured as count of bleeding episodes.	From baseline (week 0) to end of study (week 104)