do_not_disturb_altRecruitment Complete
Hemophilia A
Bayer Identifier:
20904
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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
Trial purpose
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.
Key Participants Requirements
Sex
AllAge
12 - N/ATrial summary
Enrollment Goal
62Trial Dates
May 2021 - June 2028Phase
Phase 4Could I Receive a placebo
NoProducts
Jivi (Damoctocog, BAY94-9027)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Active, not recruiting | Many Locations | Many Locations, Germany |
Active, not recruiting | Many Locations | Many Locations, Spain |
Active, not recruiting | Many Locations | Many Locations, Italy |
Active, not recruiting | Many Locations | Many Locations, Austria |
Active, not recruiting | Many Locations | Many Locations, Greece |
Recruiting | Many Locations | Many Locations, Slovenia |
Withdrawn | Many Locations | Many Locations, Russian Federation |
Withdrawn | Many Locations | Many Locations, Belgium |
Withdrawn | Many Locations | Many Locations, Denmark |
Withdrawn | Many Locations | Many Locations, France |
Withdrawn | Many Locations | Many Locations, United Kingdom |
Withdrawn | Many Locations | Many Locations, Luxembourg |
Withdrawn | Many Locations | Many Locations, Netherlands |
Withdrawn | Many Locations | Many Locations, Norway |
Withdrawn | Many Locations | Many Locations, Sweden |
Primary Outcome
- Number of participants with safety eventsdate_rangeTime Frame:At least 4 years
- Duration of safety eventsdate_rangeTime Frame:At least 4 years
- Number of participants with safety events leading to a change of treatmentdate_rangeTime Frame:At least 4 years
- Number of participants with safety events per intensityThe maximum intensity of each safety event should be assigned to one of the following categories: mild, moderate or severedate_rangeTime Frame:At least 4 years
- Number of participants with safety events with outcome of deathdate_rangeTime Frame:At least 4 years
- Number of participants with safety events related to inhibitor developmentdate_rangeTime Frame:At least 4 years
Secondary Outcome
- Number of adverse reactions (ARs) that are defined within the system organ classes nervous system and psychiatric disordersdate_rangeTime Frame:At least 4 years
- Number of adverse reactions (ARs) related to hepatic or renal functiondate_rangeTime Frame:At least 4 years
- Change from baseline in creatininedate_rangeTime Frame:At least 4 years
- Change from baseline in estimated glomerular filtration rate (eGFR)date_rangeTime Frame:At least 4 years
- Change from baseline in alanine transaminase (ALT)date_rangeTime Frame:At least 4 years
- Change from baseline in aspartate aminotransferase (AST)date_rangeTime Frame:At least 4 years
- Change from baseline in bilirubindate_rangeTime 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.date_rangeTime Frame:At least 4 years
- Number of patients with abnormal findings as assessed by neurological examinationdate_rangeTime Frame:At least 4 years
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A