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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

NCT ID: NCT04461639

Last Updated: 2025-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

62 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-14

Study Completion Date

2028-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Hemophilia A

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Damoctocog alfa pegol

Participants with hemophilia A received damoctocog alfa pegol as prophylaxis treatment prescribed by the physician as part of normal clinical practice.

Damoctocog alfa pegol (Jivi, BAY94-9027)

Intervention Type DRUG

Different prophylaxis regimens with damoctocog alfa pegol following approved local labels or any other regimen prescribed by the physician as part of normal clinical practice

Interventions

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Damoctocog alfa pegol (Jivi, BAY94-9027)

Different prophylaxis regimens with damoctocog alfa pegol following approved local labels or any other regimen prescribed by the physician as part of normal clinical practice

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Many Locations

Multiple Locations, , Austria

Site Status

Many Locations

Multiple Locations, , Germany

Site Status

Many Locations

Multiple Locations, , Greece

Site Status

Many Locations

Multiple Locations, , Italy

Site Status

Many Locations

Multiple Locations, , Slovenia

Site Status

Many Locations

Multiple Locations, , Spain

Site Status

Countries

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Belgium Denmark France Luxembourg Netherlands Norway Russia Sweden United Kingdom Austria Germany Greece Italy Slovenia Spain

Other Identifiers

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20904

Identifier Type: -

Identifier Source: org_study_id