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

Hemophilia A Clinical Trial

— HA-SAFE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04461639
• Other study ID #: 20904
• Status: Active, not recruiting
• 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
• 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

Related Conditions & MeSH terms

• Hemophilia A

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