Hemophilia AHEM-POWRNCT03932201
Evaluating Effectiveness and Long Term Safety of Damoctocog Alfa Pegol in Patients, Who Have Been Diagnosed With Hemophilia A
An observational study of Hemophilia A, run by Bayer at 29 sites in 20 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hemophilia A
- What is being tested?
- Damoctocog alfa pegol (Jivi, Bay94-9027)
- How many people
- 371 participants
- Where
- 29 sitesin 20 countries
- Study dates
- 21 Oct 2019to 31 Mar 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Previously treated patients with hemophilia A receiving damoctocog alfa pegol with any kind of treatment modality (on-demand, prop hylaxis, or intermittent prophylaxis).
Who may be able to join
- Diagnosis of hemophilia A.
- Patients previously treated for Hemophilia A.
- Patients without previous history of inhibitors or patients with previous history of inhibitors on standard prophylaxis therapy for at least 1 year prior to study entry.
- No current evidence of FVIII inhibitor or clinical suspicion of FVIII inhibitor.
- Initiation of or currently on damoctocog alfa pegol with any kind of treatment modality (on-demand, prophylaxis, or intermittent prophylaxis).
- 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.
- Contra-indications according to the local marketing authorization.
- Patient on immune tolerance induction (ITI) treatment at the time of enrollment.
Trial locations and contacts
29 sites in 20 countries.
29 sites in 20 countries
United States10 sites
University of Colorado Hemophilia and Thrombosis Center
Aurora, Colorado, 80045
University California Davis
Davis, California, 95616
East Carolina University - Brody School of Medicine
Greenville, North Carolina, 27834
Orthopaedic Hospital DBA Orthopaedic Institute for Children
Los Angeles, California, 90007
Regents of University of Minnesota
Minneapolis, Minnesota, 55454
South Alabama Medical Science Foundation
Mobile, Alabama, 36688
Tulane University
New Orleans, Louisiana, 70112
The Center for Comprehensive Care and Diagnosis of Inherited Blood Disorders
Orange, California, 92868
Banner MD Anderson Cancer Center
Phoenix, Arizona, 85012
Georgetown University
Washington D.C., District of Columbia, 20007
About this study
Official title: Observational Study Evaluating Effectiveness and Safety of Real-World Treatment With Damoctocog Alfa Pegol in Previously Treated Patients With Hemophilia A
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.
- 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
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.
| Study group | Role | What they receive |
|---|---|---|
| Previously treated patient (PTPs) with hemophilia A | Previously treated patients with hemophilia A receiving damoctocog alfa pegol with any kind of treatment modality (on-demand, prophylaxis, or intermittent prophylaxis)。 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.
Mean annualized number of reported total bleeds in patients with hemophilia A
Measured: Up to 36 months
Median annualized number of reported total bleeds in patients with hemophilia A
Measured: Up to 36 months
Secondary outcomes (21)
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.
Measured: Up to 36 months
Duration of AEs.
Measured: Up to 36 months
Treatment of AEs.
Measured: Up to 36 months
Severity of AEs.
Measured: Up to 36 months
Outcome of AEs.
Measured: Up to 36 months
Number of infusions and FVIII consumption to achieve hemostasis during surgery
Measured: Up to 36 months
Change in joint scores (HJHS)
HJHS:Hemophilia Joint Health Score
Measured: 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
Measured: Up to 36 months
Change of number of affected joints by patient
Measured: From baseline to 12 months, 24 months and 36 months
Annualized number of spontaneous, joint, and trauma bleeds
Measured: 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.
Measured: Up to 36 months
Proportion of patients with 0 bleeds, and the difference in proportion comparing to previous prophylaxis treatment.
Measured: Up to 36 months
AUC for previous FVIII products versus damoctocog alfa pegol.
AUC:Area under the plasma concentration versus time curve
Measured: Up to 36 months
Half-life [t½] for previous FVIII products versus damoctocog alfa pegol.
Measured: Up to 36 months
FVIII trough for previous FVIII products versus damoctocog alfa pegol.
Measured: Up to 36 months
FVIII peak levels for previous FVIII products versus damoctocog alfa pegol.
Measured: Up to 36 months
In-vivo recovery for previous FVIII products versus damoctocog alfa pegol.
Measured: Up to 36 months
Number of infusions to control for a bleed
Measured: 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).
Measured: 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.
Measured: 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.
Measured: From baseline to 12 months, 24 months and 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2019
- Study start21 Oct 2019
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 371 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03932201
- Sponsor's protocol ID
- 20002
- Acronym
- HEM-POWR
- Status last verified
- Jun 2026
- First submitted
- 18 Apr 2019
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Sanabria M, Alvarez Roman MT, Castaman G, Janbain M, Matsushita T, Meijer K, Oldenburg J, Friedl S, Reding MT. Design of the HEM-POWR study: a prospective, observational study of real-world treatment with damoctocog alfa pegol in patients with haemophilia A. BMJ Open. 2021 Sep 2;11(9):e044997. doi: 10.1136/bmjopen-2020-044997.
PubMed 34475142
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 Effectiveness and Safety of Real-World Treatment With Damoctocog Alfa Pegol in Previously Treated Patients With Hemophilia A
- ClinicalTrials.gov ID
- NCT03932201
- Acronym / sponsor ID
- HEM-POWR / 20002
- Conditions
- Hemophilia A
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 371 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 21 Oct 2019 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 30 Apr 2019 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Previously treated patient (PTPs) with hemophilia A | – | Drug: Damoctocog alfa pegol (Jivi, Bay94-9027)Previously treated patients with hemophilia A receiving damoctocog alfa pegol with any kind of treatment modality (on-demand, prophylaxis, or intermittent prophylaxis)。 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Previously treated patients with hemophilia A receiving damoctocog alfa pegol with any kind of treatment modality (on-demand, prop hylaxis, or intermittent prophylaxis).
Key inclusion criteria (6 listed)
- Diagnosis of hemophilia A.
- Patients previously treated for Hemophilia A.
- Patients without previous history of inhibitors or patients with previous history of inhibitors on standard prophylaxis therapy for at least 1 year prior to study entry.
- No current evidence of FVIII inhibitor or clinical suspicion of FVIII inhibitor.
- Initiation of or currently on damoctocog alfa pegol with any kind of treatment modality (on-demand, prophylaxis, or intermittent prophylaxis).
Key exclusion criteria (4 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.
- Contra-indications according to the local marketing authorization.
- 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)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. | Drug | Previously treated patient (PTPs) with hemophilia A |
Primary outcome
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
21 secondary outcomes
Occurrence of AEs.
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)
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.
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.
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.
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
Time frame: From baseline to 12 months, 24 months and 36 months
Changes of Hemo-QoL (A and SF) score
Time frame: From baseline to 12 months, 24 months and 36 months
Changes of WPAI score
Time frame: From baseline to 12 months, 24 months and 36 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.
- Derived from this study: PubMed 34475142Sanabria M, Alvarez Roman MT, Castaman G, Janbain M, Matsushita T, Meijer K, Oldenburg J, Friedl S, Reding MT. Design of the HEM-POWR study: a prospective, observational study of real-world treatment with damoctocog alfa pegol in patients with haemophilia A. BMJ Open. 2021 Sep 2;11(9):e044997. doi: 10.1136/bmjopen-2020-044997.
- Individual participant dataSharing planned: 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.
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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.
29 sites in 20 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 29 sites in 20 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 6 inclusion and 4 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 29 sites in United States, Belgium, Brazil, Canada, Colombia and 15 more countries. 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?
Mean annualized number of reported total bleeds in patients with hemophilia A (time frame: Up to 36 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03932201, which also lists 1 linked publication.
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; AzTrials last refreshed its copy on 6 Nov 2026.