Hemophilia AJOIHANCT05643560
An Observational Study Called JOIHA to Learn More About How Well the Treatment With Jivi Works to Prevent Problems With Joints in Adults With Hemophilia A.
An observational study of Hemophilia A and Prophylaxis of Bleeding, run by Bayer at 1 site in Italy.
Trial summary
This is an observational study in which data from people with hemophilia A who decide on their own or by recommendation of their doctors to take Jivi are collected and studied. In observational studies, only observations are made without specified advice or interventions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemophilia A, Prophylaxis of Bleeding
- What is being tested?
- Damoctocog alfa pegol (Jivi, BAY94-9027)
- How many people
- 33 participants
- Where
- 1 siteItaly
- Study dates
- 29 Dec 2022to 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients who initiate damoctocog alfa pegol treatment at the enrollment or who had initiated damoctocog alfa pegol treatment maximum 12 months prior to enrollment and having a HEAD-US score measurement available within 2 months prior to damoctocog alfa pegol initiation.
Who may be able to join
- Diagnosis hemophilia A with FVIII:C ≤2%.
- Patients ≥ 18 years of age.
- Previously treated for hemophilia A (PTPs).
- Patients who had initiated damoctocog alfa pegol maximum 12 months prior to enrollment into the study or who initiate damoctocog alfa pegol treatment at the enrollment , where the decision to initiate damoctocog alfa pegol has been made before the decision for study participation.
- Patients having a HEAD-US measurement available in the 2 months prior to damoctocog alfa pegol treatment initiation.
- Patients without previous history of FVIII inhibitors or patients with previous history of FVIII inhibitors on standard prophylaxis therapy for at least 1 year prior to baseline (damoctocog alfa pegol treatment initiation).
- No current evidence of FVIII inhibitor or clinical suspicion of FVIII inhibitor.
- Signed informed consent/assent.
Who cannot join
- Concurrent participation in an investigational program with interventions outside of routine clinical practice.
- Diagnosis of any other bleeding/coagulation disorder other than hemophilia A.
- Patient on immune tolerance induction (ITI) treatment at the time of enrollment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-term Treatment Outcome of Jivi® Prophylaxis on Joint Health in Adult Patients With Hemophilia A
This is an observational study in which data from people with hemophilia A who decide on their own or by recommendation of their doctors to take Jivi are collected and studied. In observational studies, only observations are made without specified advice or interventions.
Hemophilia A is a genetic bleeding disorder that is caused by the lack of a protein in the blood called "clotting factor 8" (FVIII). FVIII is naturally found in the blood where it causes the blood to clump together to help prevent and stop bleeding. People with lower levels of FVIII or with FVIII that does not work properly may bleed for a long time from minor wounds, have painful bleeding into joints, or have internal bleeding.
Read more
The study treatment, Jivi (also called damoctocog alfa pegol), is already available for doctors to prescribe to people with hemophilia A to treat and prevent bleeding. It works by replacing the missing FVIII, or the FVIII that does not work properly.
People with hemophilia A need frequent injections of FVIII products into the vein. So called standard half-life (SHL) products need to be given 2 to 4 times a week for the prevention of bleeding. In recent years, new products like Jivi called extended half-life (EHL) products have available. These products last longer in the body so that they require to be given less often with injections up to every 7 days. Thus, these treatments may be easier and more comfortable to stick to in daily life. There is no general plan concerning the best amount of treatment and the frequency of injections for the prevention of bleeding, since the severity may be different and individual risk factors have to be considered. Doctors often decide on a treatment plan based on patient's disease and response.
Clinical studies have already shown that people with hemophilia A benefit from the treatment with Jivi. However, there are no data available coming from the real-world about how well Jivi works to support joint health, measured by ultrasound (US) examination and HEAD-US score.
In this study, researchers want to learn more about how well Jivi works if used for prolonged periods of treatment under real-world settings to prevent problems with joints in people with hemophilia A. How well it works means to find out if participants' joints status can be improved by treatment with Jivi.
To do this, researchers will collect data about participants' joints status by
- making images of participants' joints by using sound waves (ultrasound), and
- using HEAD-US score after 24 months of treatment with Jivi. The researchers will then compare these data to the participants' joints status before treatment start with Jivi.
Besides this data collection, no further tests or examinations are planned in this study.
Some participants in this study will already be receiving treatment with Jivi as part of their regular care no more than 12 months. And some participants will start to take Jivi in this study as prescribed by their doctors during routine practice according to the approved product information.
The researchers will collect data from each patient for a period of 26 months after initiation of the Jivi treatment.
There are no required visits or tests in this study
- Conditions
- Hemophilia A, Prophylaxis of Bleeding
- Being tested
- Damoctocog alfa pegol (Jivi, BAY94-9027)
- Keywords
- Joint health, Hemophilia A, Clotting factor VIII (FVIII), Physical activity
- Medical subject headings
- Hemophilia A, Motor Activity
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
Intervention is given as part of routine medical practice.
| Study group | Role | What they receive |
|---|---|---|
| Hemophilia A patients | Hemophilia patients who had initiated damoctocog alfa pegol treatment . 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.
Occurrence of an unchanged or decreased HEAD-US score at 24 months after treatment initiation with damoctocog alfa pegol
The Hemophilia Early Arthropathy Detection with Ultrasound (HEAD-US) score is based on the three markers for the main joints (knees, elbows, ankles): synovitis (score: 0-2), cartilage (score: 0-4), subchondral bone (score: 0-2).
Measured: 24 months
Secondary outcomes (6)
Occurrence of an unchanged or decreased HEAD-US score at 12 months after treatment initiation with damoctocog alfa pegol
Measured: 12 months
Occurrence of a decrease in joint ABR together with a decrease in HEAD-US score 12 and 24 months after treatment initiation with damoctocog alfa pegol
ABR: Annualized bleeding rate.
Measured: 12 months and 24 months
Change in the number of target joints (as defined by ISTH) 12 months and 24 months after treatment initiation with damoctcog alfa pegol in relation to HEAD-US score
ISTH: International Society on Thrombosis and Hemostasis.
Measured: From baseline to 12 months and 24 months
Change in HEAD-US score and HJHS score 12 months and 24 months after treatment initiation with damoctocog alfa pegol
The Hemophilia Joint Health Score (HJHS) measures joint health, in the domain of body structure and function (i.e. impairment), of the joints most commonly affected by bleeding in hemophilia: the knees, ankles, and elbows.
Measured: From baseline to 12 months and 24 months
Change in physical activity (IPAQ-SF) 12 months and 24 months after treatment initiation with damoctocog alfa pegol by categorized HEAD-US score change
The International Physical Activity and sports short form (IPAQ-SF) questionnaire consists of 7 items and will ask about the time one spent being physically active in the last 7 days.
Measured: From baseline to 12 months and 24 months
Change in pain (Visual Analogue Scale) 12 months and 24 months after treatment initiation with damoctocog alfa pegol by categorized HEAD-US score change
Pain Visual Analogue Scale (VAS) score categorized as "no pain (0-4)", "mild pain (5-44)", "moderate pain (45-74)" and "severe pain (75-100)" vs. HEAD-US score change categories (worsened, unchanged, improved).
Measured: From baseline to 12 months and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2022
- Study start29 Dec 2022
- 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
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05643560
- Sponsor's protocol ID
- 22082
- Acronym
- JOIHA
- Status last verified
- Jun 2026
- First submitted
- 30 Nov 2022
- 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
- Long-term Treatment Outcome of Jivi® Prophylaxis on Joint Health in Adult Patients With Hemophilia A
- ClinicalTrials.gov ID
- NCT05643560
- Acronym / sponsor ID
- JOIHA / 22082
- Conditions
- Hemophilia A, Prophylaxis of Bleeding
- Keywords
- Joint health, Hemophilia A, Clotting factor VIII (FVIII), Physical activity
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 29 Dec 2022 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 8 Dec 2022 (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.
This is an observational study in which data from people with hemophilia A who decide on their own or by recommendation of their doctors to take Jivi are collected and studied. In observational studies, only observations are made without specified advice or interventions.
Hemophilia A is a genetic bleeding disorder that is caused by the lack of a protein in the blood called "clotting factor 8" (FVIII). FVIII is naturally found in the blood where it causes the blood to clump together to help prevent and stop bleeding. People with lower levels of FVIII or with FVIII that does not work properly may bleed for a long time from minor wounds, have painful bleeding into joints, or have internal bleeding.
The study treatment, Jivi (also called damoctocog alfa pegol), is already available for doctors to prescribe to people with hemophilia A to treat and prevent bleeding. It works by replacing the missing FVIII, or the FVIII that does not work properly.
People with hemophilia A need frequent injections of FVIII products into the vein. So called standard half-life (SHL) products need to be given 2 to 4 times a week for the prevention of bleeding. In recent years, new products like Jivi called extended half-life (EHL) products have available. These products last longer in the body so that they require to be given less often with injections up to every 7 days. Thus, these treatments may be easier and more comfortable to stick to in daily life. There is no general plan concerning the best amount of treatment and the frequency of injections for the prevention of bleeding, since the severity may be different and individual risk factors have to be considered. Doctors often decide on a treatment plan based on patient's disease and response.
Clinical studies have already shown that people with hemophilia A benefit from the treatment with Jivi. However, there are no data available coming from the real-world about how well Jivi works to support joint health, measured by ultrasound (US) examination and HEAD-US score.
In this study, researchers want to learn more about how well Jivi works if used for prolonged periods of treatment under real-world settings to prevent problems with joints in people with hemophilia A. How well it works means to find out if participants' joints status can be improved by treatment with Jivi.
To do this, researchers will collect data about participants' joints status by
- making images of participants' joints by using sound waves (ultrasound), and
- using HEAD-US score after 24 months of treatment with Jivi. The researchers will then compare these data to the participants' joints status before treatment start with Jivi.
Besides this data collection, no further tests or examinations are planned in this study.
Some participants in this study will already be receiving treatment with Jivi as part of their regular care no more than 12 months. And some participants will start to take Jivi in this study as prescribed by their doctors during routine practice according to the approved product information.
The researchers will collect data from each patient for a period of 26 months after initiation of the Jivi treatment.
There are no required visits or tests in this study
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hemophilia A patients | – | Drug: Damoctocog alfa pegol (Jivi, BAY94-9027)Hemophilia patients who had initiated damoctocog alfa pegol treatment . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients who initiate damoctocog alfa pegol treatment at the enrollment or who had initiated damoctocog alfa pegol treatment maximum 12 months prior to enrollment and having a HEAD-US score measurement available within 2 months prior to damoctocog alfa pegol initiation.
Key inclusion criteria (8 listed)
- Diagnosis hemophilia A with FVIII:C ≤2%.
- Patients ≥ 18 years of age.
- Previously treated for hemophilia A (PTPs).
- Patients who had initiated damoctocog alfa pegol maximum 12 months prior to enrollment into the study or who initiate damoctocog alfa pegol treatment at the enrollment , where the decision to initiate damoctocog alfa pegol has been made before the decision for study participation.
- Patients having a HEAD-US measurement available in the 2 months prior to damoctocog alfa pegol treatment initiation.
Key exclusion criteria (3 listed)
- Concurrent participation in an investigational program with interventions outside of routine clinical practice.
- Diagnosis of any other bleeding/coagulation disorder other than hemophilia A.
- Patient on immune tolerance induction (ITI) treatment at the time of enrollment.
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)Intervention is given as part of routine medical practice. | Drug | Hemophilia A patients |
Primary outcome
Occurrence of an unchanged or decreased HEAD-US score at 24 months after treatment initiation with damoctocog alfa pegol
Time frame: 24 months
The Hemophilia Early Arthropathy Detection with Ultrasound (HEAD-US) score is based on the three markers for the main joints (knees, elbows, ankles): synovitis (score: 0-2), cartilage (score: 0-4), subchondral bone (score: 0-2).
6 secondary outcomes
Occurrence of an unchanged or decreased HEAD-US score at 12 months after treatment initiation with damoctocog alfa pegol
Time frame: 12 months
Occurrence of a decrease in joint ABR together with a decrease in HEAD-US score 12 and 24 months after treatment initiation with damoctocog alfa pegol
Time frame: 12 months and 24 months
Change in the number of target joints (as defined by ISTH) 12 months and 24 months after treatment initiation with damoctcog alfa pegol in relation to HEAD-US score
Time frame: From baseline to 12 months and 24 months
Change in HEAD-US score and HJHS score 12 months and 24 months after treatment initiation with damoctocog alfa pegol
Time frame: From baseline to 12 months and 24 months
Change in physical activity (IPAQ-SF) 12 months and 24 months after treatment initiation with damoctocog alfa pegol by categorized HEAD-US score change
Time frame: From baseline to 12 months and 24 months
Change in pain (Visual Analogue Scale) 12 months and 24 months after treatment initiation with damoctocog alfa pegol by categorized HEAD-US score change
Time frame: From baseline to 12 months and 24 months
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.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemophilia A and Prophylaxis of Bleeding, run by Bayer at 1 site in Italy.
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 8 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 1 site in Italy. 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?
Occurrence of an unchanged or decreased HEAD-US score at 24 months after treatment initiation with damoctocog alfa pegol (time frame: 24 months). 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.