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

N/AActive Not RecruitingNCT04461639

Bayer62 enrolled

Overview

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

Enrollment

Conditions

Hemophilia A

Interventions

Damoctocog alfa pegol (Jivi, BAY94-9027)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

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

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

Locations (6)

Many Locations

Multiple Locations, Austria

Many Locations

Multiple Locations, Germany

Many Locations

Multiple Locations, Greece

Many Locations

Multiple Locations, Italy

Many Locations

Multiple Locations, Slovenia

Many Locations

Multiple Locations, Spain

Outcomes

Primary Outcomes

Number of participants with safety events

Time frame: At least 4 years

Duration of safety events

Time frame: At least 4 years

Number of participants with safety events leading to a change of treatment

Time frame: At least 4 years

Number of participants with safety events per intensity

The maximum intensity of each safety event should be assigned to one of the following categories: mild, moderate or severe

Time frame: At least 4 years

Number of participants with safety events with outcome of death

Time frame: At least 4 years

Number of participants with safety events related to inhibitor development

Time frame: At least 4 years

Secondary Outcomes

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

Time frame: At least 4 years

Number of adverse reactions (ARs) related to hepatic or renal function

Time frame: At least 4 years

Change from baseline in creatinine

Time frame: At least 4 years

Change from baseline in estimated glomerular filtration rate (eGFR)

Time frame: At least 4 years

Change from baseline in alanine transaminase (ALT)

Time frame: At least 4 years

Change from baseline in aspartate aminotransferase (AST)

Time frame: At least 4 years

Change from baseline in bilirubin

Time frame: At least 4 years

Testing for PEG plasma levels (baseline and end of study)

PEG (Polyethylene Glycol)-plasma levels at baseline and end of study will be analyzed only if PEG-plasma levels were collected in local routine clinical practice at the investigator's discretion.

Time frame: At least 4 years

Number of patients with abnormal findings as assessed by neurological examination

Time frame: At least 4 years