NCT04461639Active, not recruiting
Study to Learn More About the Safety of Drug Jivi Over a Long Period of Time in Previously Treated Patients With Hemophilia A (Bleeding Disorder Resulting From a Lack of FVIII) Who Are Receiving Jivi Regularly at Their Treating Doctors to Prevent Bleeding
Observational Study Evaluating Long-term Safety of Real-world Treatment With Damoctocog Alfa Pegol in Previously Treated Patients With Hemophilia A
Source: ClinicalTrials.gov · Last updated 1 Jul 2026
Brief summary (registry, in English)
In this observational study researchers want to learn more about the safety of drug Jivi over a long period of time. Jivi (generic name: Damoctocog alfa pegol) is an approved blood clotting Factor VIII (FVIII) medication for the treatment of hemophilia A (bleeding disorder resulting from a lack of FVIII). It is manufactured via recombinant technology and has an extended half-live, i.e. it will stay longer in the body than other FVIII products. Therefore Jivi acts longer in the body which reduces the frequency of drug injections. This study will enroll previously treated patients with hemophilia A who are receiving Jivi regularly at their treating doctors to prevent bleeding. Observation for each patient will last for at least 4 years, and medical data will be collected during patients' routine visits at their treating doctors.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 62 (actual)
- First submitted
- 18 Jun 2020
- Start date
- 14 May 2021
- Primary completion date
- 31 Mar 2027
- Lead sponsor
- Bayer
- Diseases
- Haemophilia
- NCT number
- NCT04461639
What you commit to
- Study type: Observational
- Participants enrolled: 62
- From 14 May 2021 to the primary completion date, 31 Mar 2027
- 6 sites in 6 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Known or suspected contraindications to Jivi or related products
- Mental incapacity, unwillingness or other barriers precluding adequate understanding or cooperation
- Participation in an investigational program with interventions outside of routine clinical practice
Who the study is looking for
- Signed informed consent/assent will be obtained before any study-related activities
- PTPs with hemophilia A assigned to Jivi prophylaxis treatment
- Negative FVIII inhibitor test before study entry
- Decision to initiate treatment with commercially available Jivi has been made by the treating physician before and independently from the decision to include the patient in this study
Age in the registry: 12 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Many locations Coordinator of this site? Confirm its status | Multiple Locations | Austria | Unknown status |
| Many locations Coordinator of this site? Confirm its status | Multiple Locations | Germany | Unknown status |
| Many Locations Coordinator of this site? Confirm its status | Multiple Locations | Spain | Unknown status |
| Many Locations Coordinator of this site? Confirm its status | Multiple Locations | Greece | Unknown status |
| Many Locations Coordinator of this site? Confirm its status | Multiple Locations | Italy | Unknown status |
| Many Locations Coordinator of this site? Confirm its status | Multiple Locations | Slovenia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.