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

NCT03932201 | Active Not Recruiting

• 1 other identifier: 20002
• Study Type: observational
• Target: 371
• Locations: 20 countries
• Sites: 29

Brief 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.

Conditions

Hemophilia A

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (21)

• Occurrence of AEs.

  Up to 36 months

• Duration of AEs.

  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

Study Arms (1)

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)。

Drug: Damoctocog alfa pegol (Jivi, Bay94-9027)

Interventions

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.

Previously treated patient (PTPs) with hemophilia A

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bayer: lead

Study Sites (29)

South Alabama Medical Science Foundation

Mobile, Alabama, 36688, United States

Location

Banner MD Anderson Cancer Center

Phoenix, Arizona, 85012, United States

Location

University California Davis

Davis, California, 95616, United States

Location

Orthopaedic Hospital DBA Orthopaedic Institute for Children

Los Angeles, California, 90007, United States

Location

The Center for Comprehensive Care and Diagnosis of Inherited Blood Disorders

Orange, California, 92868, United States

Location

University of Colorado Hemophilia and Thrombosis Center

Aurora, Colorado, 80045, United States

Location

Georgetown University

Washington D.C., District of Columbia, 20007, United States

Location

Tulane University

New Orleans, Louisiana, 70112, United States

Location

Regents of University of Minnesota

Minneapolis, Minnesota, 55454, United States

Location

East Carolina University - Brody School of Medicine

Greenville, North Carolina, 27834, United States

Location

Many locations

Multiple Locations, Belgium

Location

Many locations

Multiple Locations, Brazil

Location

Many locations

Multiple Locations, Canada

Location

Many locations

Multiple Locations, Colombia

Location

Many locations

Multiple Locations, Denmark

Location

Many locations

Multiple Locations, Germany

Location

Many locations

Multiple Locations, Greece

Location

Many locations

Multiple Locations, Italy

Location

Many locations

Multiple Locations, Japan

Location

Many locations

Multiple Locations, Kuwait

Location

Many locations

Multiple Locations, Netherlands

Location

Many locations

Multiple Locations, Norway

Location

Many locations

Multiple Locations, Saudi Arabia

Location

Many locations

Multiple Locations, Slovenia

Location

Many locations

Multiple Locations, Spain

Location

Many locations

Multiple Locations, Sweden

Location

Many locations

Multiple Locations, Switzerland

Location

Many locations

Multiple Locations, Taiwan

Location

Many locations

Multiple Locations, United Arab Emirates

Location

Related Publications (1)

• 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.

  PMID: 34475142 DERIVED

MeSH Terms

Conditions

Hemophilia A

Interventions

Factor VIII

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Protein Precursors; Biological Factors

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2019
• First Posted: April 30, 2019
• Study Start: October 21, 2019
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: April 9, 2026

Record last verified: 2026-04

Locations

NO (1); NL (1); BE (1); IT (1); CA (1); JP (1); AE (1); CO (1); DK (1); SA (1); ES (1); SE (1); CH (1); US (10); TW (1); KU (1); DE (1); BR (1); GR (1); SL (1)