Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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)。 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean annualized number of reported total bleeds in patients with hemophilia A | Up to 36 months | |
| Median annualized number of reported total bleeds in patients with hemophilia A | Up to 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 36 months |
| Duration of AEs. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Previously treated patients with hemophilia A receiving damoctocog alfa pegol with any kind of treatment modality (on-demand, prop hylaxis, or intermittent prophylaxis).
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| South Alabama Medical Science Foundation | Mobile | Alabama | 36688 | United States | ||
| Banner MD Anderson Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34475142 | Derived | 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. |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Up to 36 months |
| Treatment of AEs. | Up to 36 months |
| Severity of AEs. | Up to 36 months |
| Outcome of AEs. | Up to 36 months |
| Number of infusions and FVIII consumption to achieve hemostasis during surgery | Up to 36 months |
| Change in joint scores (HJHS) | HJHS:Hemophilia Joint Health Score | 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 | Up to 36 months |
| Change of number of affected joints by patient | From baseline to 12 months, 24 months and 36 months |
| Annualized number of spontaneous, joint, and trauma bleeds | 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. | Up to 36 months |
| Proportion of patients with 0 bleeds, and the difference in proportion comparing to previous prophylaxis treatment. | Up to 36 months |
| AUC for previous FVIII products versus damoctocog alfa pegol. | AUC:Area under the plasma concentration versus time curve | Up to 36 months |
| Half-life [t½] for previous FVIII products versus damoctocog alfa pegol. | Up to 36 months |
| FVIII trough for previous FVIII products versus damoctocog alfa pegol. | Up to 36 months |
| FVIII peak levels for previous FVIII products versus damoctocog alfa pegol. | Up to 36 months |
| In-vivo recovery for previous FVIII products versus damoctocog alfa pegol. | Up to 36 months |
| Number of infusions to control for a bleed | 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). | 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. | 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. | From baseline to 12 months, 24 months and 36 months |
| Phoenix |
| Arizona |
| 85012 |
| United States |
| University California Davis | Davis | California | 95616 | United States |
| Orthopaedic Hospital DBA Orthopaedic Institute for Children | Los Angeles | California | 90007 | United States |
| The Center for Comprehensive Care and Diagnosis of Inherited Blood Disorders | Orange | California | 92868 | United States |
| University of Colorado Hemophilia and Thrombosis Center | Aurora | Colorado | 80045 | United States |
| Georgetown University | Washington D.C. | District of Columbia | 20007 | United States |
| Tulane University | New Orleans | Louisiana | 70112 | United States |
| Regents of University of Minnesota | Minneapolis | Minnesota | 55454 | United States |
| East Carolina University - Brody School of Medicine | Greenville | North Carolina | 27834 | United States |
| Many locations | Multiple Locations | Belgium |
| Many locations | Multiple Locations | Brazil |
| Many locations | Multiple Locations | Canada |
| Many locations | Multiple Locations | Colombia |
| Many locations | Multiple Locations | Denmark |
| Many locations | Multiple Locations | Germany |
| Many locations | Multiple Locations | Greece |
| Many locations | Multiple Locations | Italy |
| Many locations | Multiple Locations | Japan |
| Many locations | Multiple Locations | Kuwait |
| Many locations | Multiple Locations | Netherlands |
| Many locations | Multiple Locations | Norway |
| Many locations | Multiple Locations | Saudi Arabia |
| Many locations | Multiple Locations | Slovenia |
| Many locations | Multiple Locations | Spain |
| Many locations | Multiple Locations | Sweden |
| Many locations | Multiple Locations | Switzerland |
| Many locations | Multiple Locations | Taiwan |
| Many locations | Multiple Locations | United Arab Emirates |
| ID | Term |
|---|---|
| D006467 | Hemophilia A |
| ID | Term |
|---|---|
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
Not provided
Not provided
| ID | Term |
|---|---|
| D005169 | Factor VIII |
| ID | Term |
|---|---|
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011498 | Protein Precursors |
| D001685 | Biological Factors |
Not provided
Not provided