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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03932201
Other study ID # 20002
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date October 21, 2019
Est. completion date March 31, 2027

Study information

Verified date June 2024
Source Bayer
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 371
Est. completion date March 31, 2027
Est. primary completion date December 31, 2026
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
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.

Locations

Country Name City State
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 Many locations Multiple Locations
United States University of Colorado Hemophilia and Thrombosis Center Aurora Colorado
United States University California Davis Davis California
United States East Carolina University - Brody School of Medicine Greenville North Carolina
United States Orthopaedic Hospital DBA Orthopaedic Institute for Children Los Angeles California
United States Regents of University of Minnesota Minneapolis Minnesota
United States South Alabama Medical Science Foundation Mobile Alabama
United States Tulane University New Orleans Louisiana
United States The Center for Comprehensive Care and Diagnosis of Inherited Blood Disorders Orange California
United States Banner MD Anderson Cancer Center Phoenix Arizona
United States Georgetown University Washington District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
Bayer

Countries where clinical trial is conducted

United States,  Belgium,  Brazil,  Canada,  Colombia,  Denmark,  Germany,  Greece,  Italy,  Japan,  Kuwait,  Netherlands,  Norway,  Saudi Arabia,  Slovenia,  Spain,  Sweden,  Switzerland,  Taiwan,  United Arab Emirates, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mean annualized number of reported total bleeds in patients with hemophilia A Up to 36 months
Primary Median annualized number of reported total bleeds in patients with hemophilia A Up to 36 months
Secondary 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
Secondary Duration of AEs. Up to 36 months
Secondary Treatment of AEs. Up to 36 months
Secondary Severity of AEs. Up to 36 months
Secondary Outcome of AEs. Up to 36 months
Secondary Number of infusions and FVIII consumption to achieve hemostasis during surgery Up to 36 months
Secondary Change in joint scores (HJHS) HJHS:Hemophilia Joint Health Score From baseline to 12 months, 24 months and 36 months
Secondary 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
Secondary Change of number of affected joints by patient From baseline to 12 months, 24 months and 36 months
Secondary Annualized number of spontaneous, joint, and trauma bleeds Up to 36 months
Secondary 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
Secondary Proportion of patients with 0 bleeds, and the difference in proportion comparing to previous prophylaxis treatment. Up to 36 months
Secondary AUC for previous FVIII products versus damoctocog alfa pegol. AUC:Area under the plasma concentration versus time curve Up to 36 months
Secondary Half-life [t½] for previous FVIII products versus damoctocog alfa pegol. Up to 36 months
Secondary FVIII trough for previous FVIII products versus damoctocog alfa pegol. Up to 36 months
Secondary FVIII peak levels for previous FVIII products versus damoctocog alfa pegol. Up to 36 months
Secondary In-vivo recovery for previous FVIII products versus damoctocog alfa pegol. Up to 36 months
Secondary Number of infusions to control for a bleed Up to 36 months
Secondary 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
Secondary 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
Secondary 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
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