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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
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)
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