Clinical trial NCT06285071: Post-Marketing Surveillance (All Case Surveillance) on Treatment With Alhemo® in Patients With Haemophilia A or Haemophilia B With Inhibitors
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
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Haemophilia A
Haemophilia B
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2024-02-29
Enrollment: 23
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with haemophilia A or haemophilia B with inhibitors will be treated with commercially available concizumab according to routine clinical practice at the discretion of the treating physician.

Brief 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.


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

Primary outcomes:
measure: Number of adverse reaction (AR)
timeFrame: From baseline (week 0) to end of study (week 104)
Secondary outcomes:
measure: Number of serious adverse reaction (SAR)
timeFrame: From baseline (week 0) to end of study (week 104)
measure: Number of serious adverse event (SAE)
timeFrame: From baseline (week 0) to end of study (week 104)
measure: Number of thromboembolic adverse event (AE)
timeFrame: From baseline (week 0) to end of study (week 104)
measure: Number of shock/anaphylaxis AE
timeFrame: From baseline (week 0) to end of study (week 104)
measure: Number of treated spontaneous and traumatic bleeding episodes
timeFrame: From baseline (week 0) to end of study (week 104)
measure: Number of treated spontaneous and traumatic target joint bleeding episodes
timeFrame: From baseline (week 0) to end of study (week 104)
measure: Number of all treatment requiring bleeding episode
timeFrame: From baseline (week 0) to end of study (week 104)
Other outcomes:
Locations:
city: Toshima
country: Japan
facility: Novo Nordisk Investigational Site
state: Tokyo
city: Aomori
country: Japan
facility: Mutsu general hospital
city: Fukuoka
country: Japan
facility: Kyushu university hospital_Pediatrics
city: Hokkaido
country: Japan
facility: Sapporo Tokushukai Hospital_Pediatrics
city: Kagoshima
country: Japan
facility: Kagoshima City Hospital
city: Kanagawa
country: Japan
facility: St. Marianna University School of Medicine Hospital_Pediatrics
city: Tokyo
country: Japan
facility: Tokyo Medical University Hospital
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency dept. 2834
role: STUDY_DIRECTOR
References: