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NCT Number: NCT04461639

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

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.

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Key information

Conditions

Hemophilia A Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations, Multiple Locations, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Damoctocog alfa pegol (Jivi, Bay94-9027)

Drug

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

Primary outcomes

  1. Number of participants with safety events

    Time frame: At least 4 years

  2. Duration of safety events

    Time frame: At least 4 years

  3. Number of participants with safety events leading to a change of treatment

    Time frame: At least 4 years

  4. Number of participants with safety events per intensity

    Time frame: At least 4 years

    The maximum intensity of each safety event should be assigned to one of the following categories: mild, moderate or severe

  5. Number of participants with safety events with outcome of death

    Time frame: At least 4 years

  6. Number of participants with safety events related to inhibitor development

    Time frame: At least 4 years

Secondary outcomes

  1. Number of adverse reactions (ARs) that are defined within the system organ classes nervous system and psychiatric disorders

    Time frame: At least 4 years

  2. Number of adverse reactions (ARs) related to hepatic or renal function

    Time frame: At least 4 years

  3. Change from baseline in creatinine

    Time frame: At least 4 years

  4. Change from baseline in estimated glomerular filtration rate (eGFR)

    Time frame: At least 4 years

  5. Change from baseline in alanine transaminase (ALT)

    Time frame: At least 4 years

  6. Change from baseline in aspartate aminotransferase (AST)

    Time frame: At least 4 years

  7. Change from baseline in bilirubin

    Time frame: At least 4 years

  8. Testing for PEG plasma levels (baseline and end of study)

    Time frame: At least 4 years

    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.

  9. Number of patients with abnormal findings as assessed by neurological examination

    Time frame: At least 4 years

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Acronym: HA-SAFE

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Jul 8, 2020
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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