Trial Condition(s):
Hemophilia A
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 (HA-SAFE)
Bayer Identifier:
20904
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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.
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Many Locations Many Locations, Germany | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Many Locations Many Locations, Spain | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Many Locations Many Locations, Italy | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Many Locations Many Locations, Austria | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Many Locations Many Locations, Greece | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Many Locations Many Locations, Slovenia | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Trial Design
Observational study evaluating long-term safety of real-world treatment with damoctocog alfa pegol in previously treated patients with hemophilia A
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Number of participants with safety eventsTimeframe: At least 4 years
- Duration of safety eventsTimeframe: At least 4 years
- Number of participants with safety events leading to a change of treatmentTimeframe: 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 severeTimeframe: At least 4 years
- Number of participants with safety events with outcome of deathTimeframe: At least 4 years
- Number of participants with safety events related to inhibitor developmentTimeframe: At least 4 years
Secondary Outcome
- Number of adverse reactions (ARs) that are defined within the system organ classes nervous system and psychiatric disordersTimeframe: At least 4 years
- Number of adverse reactions (ARs) related to hepatic or renal functionTimeframe: At least 4 years
- Change from baseline in creatinineTimeframe: At least 4 years
- Change from baseline in estimated glomerular filtration rate (eGFR)Timeframe: At least 4 years
- Change from baseline in alanine transaminase (ALT)Timeframe: At least 4 years
- Change from baseline in aspartate aminotransferase (AST)Timeframe: At least 4 years
- Change from baseline in bilirubinTimeframe: 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.Timeframe: At least 4 years
- Number of patients with abnormal findings as assessed by neurological examinationTimeframe: At least 4 years
Additional Information
Not Available
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