An observational study in Hemophilia A, sponsored by Bayer. Active, not recruiting at 29 sites in 20 countries. Per ClinicalTrials.gov, last updated 2026-07-01.
Sponsored by Bayer · Observational
Among 57 studies in Hemophilia A by Bayer — 3 open to participants now, 6 under way, none of them phase 3. Hemophilia A · Bayer.
Among the 57 studies in Hemophilia A by Bayer, this one is the 2nd largest by enrollment of the 26 observational ones that give a count, is one of 4 that started in 2019, is one of 26 observational ones, and was the 44th registered.
844 studies on the registry are indexed under Hemophilia A; 136 are open to participants now.
Browse Hemophilia A studies →3 of the 57 studies in Hemophilia A by Bayer are open now, in 12 countries. Recruiting first, the newest first:
Bayer · Sites in United States, Brazil, Canada and 8 more countries
Ages 7–12
Bayer · Sites in Korea, Republic of
Ages 12+
Bayer
Ages 18+
By country, each count listing its studies:
Of the 86 Hemophilia A studies recruiting now, 51 (59%) set no upper age limit and 30 (35%) stop at 75 or younger; 54 take children under 18; 10 take healthy volunteers.
This study: all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
57 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 11 · Phase 2 5 · Phase 3 9 · Phase 4 8
First in 2002; this study’s year is marked. 4 started in 2019.
This study's enrollment of 371 is above the median of 81 across 310 observational studies indexed under Hemophilia A.
Median enrollment 27 across the 31 interventional studies, 67 across the 26 observational. Of the 50 that completed or were terminated, 14 (28%) have results posted.
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Bayer is the lead sponsor of 1,674 studies on the registry; 51 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 132 (62%) have results posted.
3 of the studies in Hemophilia A by Bayer that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03932201BayerEvaluating Effectiveness and Long Term Safety of Damoctocog Alfa Pegol in Patients, Who Have Been Diagnosed With Hemophilia A | 2026-12-31 |
| NCT05643560BayerAn 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. | 2027-03-31 |
| NCT04461639BayerStudy 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 | 2027-03-31 |
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Among the 57 studies in Hemophilia A by Bayer, from their registry updates:
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The aim of the HEM-POWR study is to understand better how Damoctocog alfa pegol (Jivi) is used to treat people with Hemophilia A in day-to-day life, how well the treatment is tolerated and how satisfied patients and physicians are with the treatment.
Previously treated patients with hemophilia A receiving damoctocog alfa pegol with any kind of treatment modality (on-demand, prop hylaxis, or intermittent prophylaxis).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Previously treated patients with hemophilia A receiving damoctocog alfa pegol with any kind of treatment modality (on-demand, prophylaxis, or intermittent prophylaxis)。
Drug: Damoctocog alfa pegol (Jivi, Bay94-9027)
Follow clinical practice. BAY94-9027 is a B-domain-deleted recombinant factor VIII (rFVIII) product site-specifically conjugated to a single (dual 30-kDa branched) 60-kDa polyethylene glycol (PEG) molecule. BAY 94-9027 is intended for prophylaxis and treatment of bleeds in patients with hemophilia A aged ≥12 years, with a narrow, predictable weekly dose that allows for the treatment regimen to be tailored to individual patient needs.
Mean annualized number of reported total bleeds in patients with hemophilia A
Time frame: Up to 36 months
Median annualized number of reported total bleeds in patients with hemophilia A
Time frame: Up to 36 months
Occurrence of AEs.
Adverse Events (AEs) includes: AEs of special interest, Adverse Event, Serious Adverse Event, Adverse reaction. AEs of special interest includes: hypersensitivity reactions, loss of drug effect, renal impairment, neurocognitive disorders, inhibitor development.
Time frame: Up to 36 months
Duration of AEs.
Time frame: Up to 36 months
Treatment of AEs.
Time frame: Up to 36 months
Severity of AEs.
Time frame: Up to 36 months
Outcome of AEs.
Time frame: Up to 36 months
Number of infusions and FVIII consumption to achieve hemostasis during surgery
Time frame: Up to 36 months
Change in joint scores (HJHS)
HJHS:Hemophilia Joint Health Score
Time frame: From baseline to 12 months, 24 months and 36 months
Joint status evaluation by ultrasound (HEAD-US score), if available or part of standard clinical practice.
HEAD-US:Hemophilia Early Arthropathy Detection with Ultrasound
Time frame: Up to 36 months
Change of number of affected joints by patient
Time frame: From baseline to 12 months, 24 months and 36 months
Annualized number of spontaneous, joint, and trauma bleeds
Time frame: Up to 36 months
Number of reported bleeds during the study compared with number of reported bleeds for previous FVIII products in the 12 months prior to enrollment into the study.
Bleeds includes total, spontaneous, joint, and trauma.
Time frame: Up to 36 months
Proportion of patients with 0 bleeds, and the difference in proportion comparing to previous prophylaxis treatment.
Time frame: Up to 36 months
AUC for previous FVIII products versus damoctocog alfa pegol.
AUC:Area under the plasma concentration versus time curve
Time frame: Up to 36 months
Half-life [t½] for previous FVIII products versus damoctocog alfa pegol.
Time frame: Up to 36 months
FVIII trough for previous FVIII products versus damoctocog alfa pegol.
Time frame: Up to 36 months
FVIII peak levels for previous FVIII products versus damoctocog alfa pegol.
Time frame: Up to 36 months
In-vivo recovery for previous FVIII products versus damoctocog alfa pegol.
Time frame: Up to 36 months
Number of infusions to control for a bleed
Time frame: Up to 36 months
Changes of Hemo-SAT A score
Hemo-SAT A:Hemophilia Treatment Satisfaction Questionnaire for adults。The Hemo-SAT questionnaire version for adults (Hemo-SAT A) consists of 34 items pertaining to 6 dimensions (Ease \& Convenience, Efficacy, Burden, Specialist/Nurses, Center/Hospital, General Satisfaction).
Time frame: From baseline to 12 months, 24 months and 36 months
Changes of Hemo-QoL (A and SF) score
Hemo-QoL-A:Hemophilia Quality of Life Measure for adults Hemo-QoL-SF:Hemophilia Quality of Life short form for children Hemo-QoL-A is a hemophiliaspecific quality of life questionnaire for adults aged 18 years and above. The questionnaire has 41 items covering 6 domains: Physical Functioning, Role Functioning, Worry, Consequences of Bleeding, Emotional Impact, and Treatment Concerns. For patients younger than 18 years, the Hemo-QoL-SF Questionnaire for children and adolescents (12 to 17 years) is used. The Hemo-QoL-SF contains 35 questions covering 9 domains: Physical Health, View of Yourself, Family, Friends, Others, Sports, Dealing, and Treatment.
Time frame: From baseline to 12 months, 24 months and 36 months
Changes of WPAI score
WPAI:Work Productivity and Activity Impairment Scale。 Scores are expressed as percentages of impairment/ productivity loss, with higher scores indicating greater impairment.
Time frame: From baseline to 12 months, 24 months and 36 months
Plan to share: Undecided — Availability of this study's data will 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.clinicalstudydatarequest.com 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 Study sponsors section of the portal.
Started Oct 2019 (actual). Primary completion is estimated for Dec 2026, 86 months after the start.
Of 53 industry-sponsored observational studies under Hemophilia A, half reached primary completion within 58 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 79. This study's planned 86 months is above that.
Counting every sponsor, half of 131 studies reached it within 45 months; a quarter within 25 and three quarters within 79.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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