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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04461639
Other study ID # 20904
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date May 14, 2021
Est. completion date June 30, 2028

Study information

Verified date June 2024
Source Bayer
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 62
Est. completion date June 30, 2028
Est. primary completion date June 30, 2028
Accepts healthy volunteers No
Gender All
Age group 12 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
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

Locations

Country Name City State
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 Many Locations Multiple Locations

Sponsors (1)

Lead Sponsor Collaborator
Bayer

Countries where clinical trial is conducted

Austria,  Germany,  Greece,  Italy,  Slovenia,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of participants with safety events At least 4 years
Primary Duration of safety events At least 4 years
Primary Number of participants with safety events leading to a change of treatment At least 4 years
Primary 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 At least 4 years
Primary Number of participants with safety events with outcome of death At least 4 years
Primary Number of participants with safety events related to inhibitor development At least 4 years
Secondary Number of adverse reactions (ARs) that are defined within the system organ classes nervous system and psychiatric disorders At least 4 years
Secondary Number of adverse reactions (ARs) related to hepatic or renal function At least 4 years
Secondary Change from baseline in creatinine At least 4 years
Secondary Change from baseline in estimated glomerular filtration rate (eGFR) At least 4 years
Secondary Change from baseline in alanine transaminase (ALT) At least 4 years
Secondary Change from baseline in aspartate aminotransferase (AST) At least 4 years
Secondary Change from baseline in bilirubin At least 4 years
Secondary 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. At least 4 years
Secondary Number of patients with abnormal findings as assessed by neurological examination At least 4 years
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