do_not_disturb_altRecruitment Complete

Hemophilia A

Bayer Identifier:

20904

ClinicalTrials.gov Identifier:

NCT04461639

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

All

Age

12 - N/A
  • - 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
  • - 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
62
Trial Dates
May 2021 - June 2028
Phase
Phase 4
Could I Receive a placebo
No
Products
Jivi (Damoctocog, BAY94-9027)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Active, not recruiting
Many LocationsMany Locations, Germany
Active, not recruiting
Many LocationsMany Locations, Spain
Active, not recruiting
Many LocationsMany Locations, Italy
Active, not recruiting
Many LocationsMany Locations, Austria
Active, not recruiting
Many LocationsMany Locations, Greece
Recruiting
Many LocationsMany Locations, Slovenia
Withdrawn
Many LocationsMany Locations, Russian Federation
Withdrawn
Many LocationsMany Locations, Belgium
Withdrawn
Many LocationsMany Locations, Denmark
Withdrawn
Many LocationsMany Locations, France
Withdrawn
Many LocationsMany Locations, United Kingdom
Withdrawn
Many LocationsMany Locations, Luxembourg
Withdrawn
Many LocationsMany Locations, Netherlands
Withdrawn
Many LocationsMany Locations, Norway
Withdrawn
Many LocationsMany Locations, Sweden

Primary Outcome

  • Number of participants with safety events
    date_rangeTime Frame:
    At least 4 years
  • Duration of safety events
    date_rangeTime Frame:
    At least 4 years
  • Number of participants with safety events leading to a change of treatment
    date_rangeTime 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
    date_rangeTime Frame:
    At least 4 years
  • Number of participants with safety events with outcome of death
    date_rangeTime Frame:
    At least 4 years
  • Number of participants with safety events related to inhibitor development
    date_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 disorders
    date_rangeTime Frame:
    At least 4 years
  • Number of adverse reactions (ARs) related to hepatic or renal function
    date_rangeTime Frame:
    At least 4 years
  • Change from baseline in creatinine
    date_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 bilirubin
    date_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 examination
    date_rangeTime Frame:
    At least 4 years

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
N/A