Hemophilia AHA-SAFENCT04461639
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
An observational study of Hemophilia A, run by Bayer at 6 sites in 6 countries.
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). Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Hemophilia A
- What is being tested?
- Damoctocog alfa pegol (Jivi, BAY94-9027)
- How many people
- 62 participants
- Where
- 6 sitesin 6 countries
- Study dates
- 14 May 2021to 30 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
6 sites in 6 countries.
6 sites in 6 countries
About this study
Official title: Observational Study Evaluating Long-term Safety of Real-world Treatment With Damoctocog Alfa Pegol in Previously Treated Patients With Hemophilia A
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
- Being tested
- Damoctocog alfa pegol (Jivi, BAY94-9027)
- Medical subject headings
- Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Damoctocog alfa pegol | Participants with hemophilia A received damoctocog alfa pegol as prophylaxis treatment prescribed by the physician as part of normal clinical practice. Receives: Drug: Damoctocog alfa pegol (Jivi, BAY94-9027) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with safety events
Measured: At least 4 years
Duration of safety events
Measured: At least 4 years
Number of participants with safety events leading to a change of treatment
Measured: 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
Measured: At least 4 years
Number of participants with safety events with outcome of death
Measured: At least 4 years
Number of participants with safety events related to inhibitor development
Measured: 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
Measured: At least 4 years
Number of adverse reactions (ARs) related to hepatic or renal function
Measured: At least 4 years
Change from baseline in creatinine
Measured: At least 4 years
Change from baseline in estimated glomerular filtration rate (eGFR)
Measured: At least 4 years
Change from baseline in alanine transaminase (ALT)
Measured: At least 4 years
Change from baseline in aspartate aminotransferase (AST)
Measured: At least 4 years
Change from baseline in bilirubin
Measured: 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.
Measured: At least 4 years
Number of patients with abnormal findings as assessed by neurological examination
Measured: At least 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2020
- Study start14 May 2021
- Primary completion31 Mar 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemophilia AStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04461639
- Sponsor's protocol ID
- 20904
- Acronym
- HA-SAFE
- Status last verified
- Jun 2026
- First submitted
- 18 Jun 2020
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study Evaluating Long-term Safety of Real-world Treatment With Damoctocog Alfa Pegol in Previously Treated Patients With Hemophilia A
- ClinicalTrials.gov ID
- NCT04461639
- Acronym / sponsor ID
- HA-SAFE / 20904
- Conditions
- Hemophilia A
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 62 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 14 May 2021 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 8 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Damoctocog alfa pegol | – | Drug: Damoctocog alfa pegol (Jivi, BAY94-9027)Participants with hemophilia A received damoctocog alfa pegol as prophylaxis treatment prescribed by the physician as part of normal clinical practice. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Drug | Damoctocog alfa pegol |
Primary outcome
Number of participants with safety events
Time frame: At least 4 years
Duration of safety events
Time frame: At least 4 years
Number of participants with safety events leading to a change of treatment
Time frame: At least 4 years
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
Number of participants with safety events with outcome of death
Time frame: At least 4 years
Number of participants with safety events related to inhibitor development
Time frame: At least 4 years
9 secondary outcomes
Number of adverse reactions (ARs) that are defined within the system organ classes nervous system and psychiatric disorders
Time frame: At least 4 years
Number of adverse reactions (ARs) related to hepatic or renal function
Time frame: At least 4 years
Change from baseline in creatinine
Time frame: At least 4 years
Change from baseline in estimated glomerular filtration rate (eGFR)
Time frame: At least 4 years
Change from baseline in alanine transaminase (ALT)
Time frame: At least 4 years
Change from baseline in aspartate aminotransferase (AST)
Time frame: At least 4 years
Change from baseline in bilirubin
Time frame: At least 4 years
Testing for PEG plasma levels (baseline and end of study)
Time frame: At least 4 years
Number of patients with abnormal findings as assessed by neurological examination
Time frame: At least 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: No. Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Related trials for Hemophilia A
RecruitingObservational study
The CACHE Study: Coronary Artery Care in HaEmophilia
Haemophilia, Cardiovascular Diseases
Active, not recruitingObservational study
A Study to Learn About the Study Medicine -Hympavzi in Congenital Hemophilia Patients Without Inhibitors in Japan.
Hemophilia A or B
RecruitingPhase 1/2
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of NXT007 in Persons With Severe or Moderate Hemophilia A
Hemophilia A
Active, not recruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Factor IX Gene Therapy With PF-06838435 in Adult Males With Moderately Severe to Severe Hemophilia B
Hemophilia B
Not yet recruiting
Safety of Intraosseous Anaesthesia in Children With Haemophilia
Haemophilia A, Haemophilia B
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemophilia A, run by Bayer at 6 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Austria, Germany, Greece, Italy, Slovenia and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with safety events (time frame: At least 4 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.