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

NCT04461639 | Active Not Recruiting

• 1 other identifier: 20904
• Study Type: observational
• Target: 62
• Locations: 6 countries
• Sites: 6

Brief 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.

Conditions

Hemophilia A

Outcome Measures

Primary Outcomes (6)

• Number of participants with safety events

  At least 4 years

• Duration of safety events

  At least 4 years

• Number of participants with safety events leading to a change of treatment

  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

  At least 4 years

• Number of participants with safety events with outcome of death

  At least 4 years

• Number of participants with safety events related to inhibitor development

  At least 4 years

Secondary Outcomes (9)

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

  At least 4 years

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

  At least 4 years

• Change from baseline in creatinine

  At least 4 years

• Change from baseline in estimated glomerular filtration rate (eGFR)

  At least 4 years

• Change from baseline in alanine transaminase (ALT)

  At least 4 years

Study Arms (1)

Damoctocog alfa pegol

Participants with hemophilia A received damoctocog alfa pegol as prophylaxis treatment prescribed by the physician as part of normal clinical practice.

Drug: Damoctocog alfa pegol (Jivi, BAY94-9027)

Interventions

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

Damoctocog alfa pegol

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All previously treated patients (PTPs) with hemophilia A receiving prophylaxis with damoctocog alfa pegol will be eligible to be enrolled in the study. Indications and contra-indications according to the local market authorization will be carefully considered

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (6)

Many Locations

Multiple Locations, Austria

Location

Many Locations

Multiple Locations, Germany

Location

Many Locations

Multiple Locations, Greece

Location

Many Locations

Multiple Locations, Italy

Location

Many Locations

Multiple Locations, Slovenia

Location

Many Locations

Multiple Locations, Spain

Location

MeSH Terms

Conditions

Hemophilia A

Interventions

Factor VIII

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Protein Precursors; Biological Factors

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2020
• First Posted: July 8, 2020
• Study Start: May 14, 2021
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); IT (1); SL (1); ES (1); DE (1); GR (1)