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

Brief Title

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

Official Title

Observational Study Evaluating Long-term Safety of Real-world Treatment With Damoctocog Alfa Pegol in Previously Treated Patients With Hemophilia A

Brief Summary

      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.

Study Type

Observational

Primary Outcome

Number of participants with safety events

Secondary Outcome

 Number of adverse reactions (ARs) that are defined within the system organ classes nervous system and psychiatric disorders

Condition

Hemophilia A

Intervention

Damoctocog alfa pegol (Jivi, BAY94-9027)

Study Arms / Comparison Groups

 Damoctocog alfa pegol

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

Start Date

May 14, 2021

Completion Date

June 30, 2028

Primary Completion Date

June 30, 2028

Eligibility Criteria

        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

Gender

All

Ages

12 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, (+)1-888-84 22937, [email protected]

Location Countries

Austria

Location Countries

Austria

Administrative Informations

NCT ID

NCT04461639

Organization ID

Responsible Party

Sponsor

Study Sponsor

Bayer

Study Sponsor

, ,

Verification Date

September 2022