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Evaluating Effectiveness and Long Term Safety of Damoctocog Alfa Pegol in Patients, Who Have Been Diagnosed With Hemophilia A

NCT ID: NCT03932201

Last Updated: 2025-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

371 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-21

Study Completion Date

2027-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hemophilia A

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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)。

Damoctocog alfa pegol (Jivi, Bay94-9027)

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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South Alabama Medical Science Foundation

Mobile, Alabama, United States

Site Status

Banner MD Anderson Cancer Center

Phoenix, Arizona, United States

Site Status

University California Davis

Davis, California, United States

Site Status

Orthopaedic Hospital DBA Orthopaedic Institute for Children

Los Angeles, California, United States

Site Status

The Center for Comprehensive Care and Diagnosis of Inherited Blood Disorders

Orange, California, United States

Site Status

University of Colorado Hemophilia and Thrombosis Center

Aurora, Colorado, United States

Site Status

Georgetown University

Washington D.C., District of Columbia, United States

Site Status

Tulane University

New Orleans, Louisiana, United States

Site Status

Regents of University of Minnesota

Minneapolis, Minnesota, United States

Site Status

East Carolina University - Brody School of Medicine

Greenville, North Carolina, United States

Site Status

Many locations

Multiple Locations, , Belgium

Site Status

Many locations

Multiple Locations, , Brazil

Site Status

Many locations

Multiple Locations, , Canada

Site Status

Many locations

Multiple Locations, , Colombia

Site Status

Many locations

Multiple Locations, , Denmark

Site Status

Many locations

Multiple Locations, , Germany

Site Status

Many locations

Multiple Locations, , Greece

Site Status

Many locations

Multiple Locations, , Italy

Site Status

Many locations

Multiple Locations, , Japan

Site Status

Many locations

Multiple Locations, , Kuwait

Site Status

Many locations

Multiple Locations, , Netherlands

Site Status

Many locations

Multiple Locations, , Norway

Site Status

Many locations

Multiple Locations, , Saudi Arabia

Site Status

Many locations

Multiple Locations, , Slovenia

Site Status

Many locations

Multiple Locations, , Spain

Site Status

Many locations

Multiple Locations, , Sweden

Site Status

Many locations

Multiple Locations, , Switzerland

Site Status

Many locations

Multiple Locations, , Taiwan

Site Status

Many locations

Multiple Locations, , United Arab Emirates

Site Status

Countries

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Austria China Finland France Luxembourg Mexico Portugal Russia United States Belgium Brazil Canada Colombia Denmark Germany Greece Italy Japan Kuwait Netherlands Norway Saudi Arabia Slovenia Spain Sweden Switzerland Taiwan United Arab Emirates

References

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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.

Reference Type DERIVED
PMID: 34475142 (View on PubMed)

Other Identifiers

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20002

Identifier Type: -

Identifier Source: org_study_id