Evidence map›Paper›PMID 41122986›Full record

Observational studyEuropean journal of haematology2026

Real-World Effectiveness and Safety of Damoctocog Alfa Pegol in Severe and Nonsevere Patients With Hemophilia A From the Prospective, Multinational, Ongoing HEM-POWR Study.

Mark T Reding, María Teresa Alvarez Román, Giancarlo Castaman, Maissaa Janbain, Tadashi Matsushita, Karina Meijer, Kathrin Schmidt, Johannes Oldenburg

Registry-linked trialAbstract readMulticenter StudyObservational Study
PubMed Full text at PMC Publisher
In one paragraph

Observational study in European journal of haematology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03932201 (Observational Study Evaluating Effectiveness and Safety of Real-World Treatment With Damoctocog Alfa Pegol in Previously Treated Patients With Hemophilia A), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03932201 active not recruitingnot on this map

Observational Study Evaluating Effectiveness and Safety of Real-World Treatment With Damoctocog Alfa Pegol in Previously Treated Patients With Hemophilia A

TypeobservationalSponsorBayerRan2019 to 2027Enrolled371ConditionsHemophilia AArmsDamoctocog alfa pegol (Jivi, Bay94-9027)
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Observational
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Mark T RedingCenter for Bleeding and Clotting Disorders, University of Minnesota Medical Center, Minneapolis, Minnesota, USA.
María Teresa Alvarez RománThrombosis and Haemostasis Unit, Hospital Universitario La Paz, Madrid, Spain.
Giancarlo CastamanDepartment of Oncology, Center for Bleeding Disorders and Coagulation, Careggi University Hospital, Florence, Italy.
Maissaa JanbainDeming Department of Internal Medicine, Section of Hematology and Medical Oncology, Tulane School of Medicine, New Orleans, Louisiana, USA.
Tadashi MatsushitaDepartment of Transfusion Medicine, Nagoya University Hospital, Nagoya, Japan.
Karina MeijerDepartment of Hematology, University Medical Center Groningen, Groningen, the Netherlands.
Kathrin SchmidtOS Operations, Bayer, Berlin, Germany.
Johannes OldenburgInstitute of Experimental Hematology and Transfusion Medicine, University Hospital Bonn, Medical Faculty, University of Bonn, Bonn, Germany.

Funding

Bayer
6 · The paper itself

Abstract

objectivesTo assess the effectiveness and safety of damoctocog alfa pegol in patients with severe and nonsevere hemophilia A in the fifth interim analysis of the ongoing HEM-POWR study.

methodsHEM-POWR (NCT03932201) is a multinational, Phase 4, prospective observational study. The key objectives were the annualized bleeding rate (ABR) and adverse events.

resultsAt data cutoff (July 8, 2024), the safety analysis set and full analysis set (FAS) included 370 and 270 patients, respectively. In the modified FAS (patients with ≥ 90 days of bleed data), the mean (standard deviation; SD) ABR for total bleeds was 2.8 (5.9) 12 months prior to damoctocog alfa pegol initiation with the previous FVIII product and 2.1 (4.8) during the observation period. Bleed protection with damoctocog alfa pegol was maintained across disease severity, age group, BMI group, dosing regimen, and patient inhibitor history. One patient died due to spinal cord ischemia unrelated to the study drug. One patient developed a transient low-titer inhibitor, which resolved without clinical consequence.

conclusionsThis updated analysis further demonstrated the effectiveness, acceptable safety profile, and tolerability of damoctocog alfa pegol for previously treated patients with severe and nonsevere hemophilia A from adolescence to older age in a real-world setting.

Indexed as

Factor VIIIHemophilia AAdolescentAdultAgedChildChild, PreschoolFemaleHemorrhageHumansMaleMiddle AgedProspective StudiesSeverity of Illness IndexTreatment OutcomeYoung AdultFactor VIIIbleedingextended half‐lifehemophilia Ainhibitorsnonseverereal‐worldsafety

Identifiers

PMID41122986
PMCPMC12781148

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.