Post-Marketing Surveillance (Use-results Surveillance) With Esperoct®
- Conditions
- Haemophilia A
- Interventions
- Registration Number
- NCT04334057
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 15
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients with haemophilia A Turoctocog alfa pegol New patients who have not previously been exposed to Esperoct® (Turoctocog alfa pegol or N8-GP in clinical trials) are eligible for this study.
- Primary Outcome Measures
Name Time Method Number of adverse reactions (ARs) reported during the observation period From baseline (week 0) to end of study (week 104) Count
- Secondary Outcome Measures
Name Time Method Number of serious adverse events (SAEs) reported during the observation period From baseline (week 0) to end of study (week 104) Count
Number of patients who have confirmed inhibitory antibodies against FVIII during the observation period From baseline (week 0) to end of study (week 104) Count
Evaluation of the haemostatic response of Esperoct® measured as number of successes in treatment of bleeds in perioperative management during surgical procedures From baseline (week 0) to end of study (week 104) Count, assessed as success/failure based on a four-point scale for haemostatic response (excellent, good, moderate and poor) by counting excellent and good as success and moderate and poor as failure
Number of serious adverse reactions (SARs) reported during the observation period From baseline (week 0) to end of study (week 104) Count
Number of bleeding episodes requiring treatment for patients using Esperoct® during the observation period assessed by annual bleeding rate (ABR) From baseline (week 0) to end of study (week 104) Count
Evaluation of the haemostatic response of Esperoct® measured as number of successes for treatment requiring bleeds From baseline (week 0) to end of study (week 104) Count, assessed based on a four-point scale (excellent, good, moderate and poor) by counting excellent and good as success and moderate and poor as failure
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇯🇵Yokohama-shi, Kanagawa, Japan