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Hemophilia A patients for Hemophilia A (LIFE-ACTIVE Trial)
N/A
Waitlist Available
Research Sponsored by Bayer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days at each visit (baseline, year 1, 2 and 3)
Awards & highlights
LIFE-ACTIVE Trial Summary
In this study researcher want to learn more about the change of physical activity of hemophilia A patients treated with damoctocog alfa pegol. Patients enrolled in this study will be wearing a small device measuring daily active time. Researcher will compare these physical activity data with patient's clinical data including bleeding events to gain information on how bleeding levels are related to the activity level of the patients. The study aims to enroll about 80 patients who are at the same time also participating in the HEM-POWR study (NCT03932201) evaluating the effectiveness and safety of damoctocog alfa pegol.
LIFE-ACTIVE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days at each visit (baseline, year 1, 2 and 3)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days at each visit (baseline, year 1, 2 and 3)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Category of physical non-sedentary activity
Time of physical non-sedentary activity per week
Secondary outcome measures
Actual wear time per week
Association between physical activity time per week and PRO-scores for health-related life quality
Association between physical activity time per week and PRO-scores for treatment satisfaction
+11 moreSide effects data
From 2022 Phase 4 trial • 32 Patients • NCT0408545816%
Upper respiratory tract infection
9%
Arthralgia
9%
Limb injury
6%
Tooth extraction
6%
Back pain
6%
Cough
6%
Epistaxis
6%
Pyrexia
3%
Fall
3%
Osteoarthritis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Severe Hemophilia A Patients With Damoctocog Alfa Pegol (Jivi, BAY94-9027) Treatment
LIFE-ACTIVE Trial Design
1Treatment groups
Experimental Treatment
Group I: Hemophilia A patientsExperimental Treatment1 Intervention
Patients with hemophilia A who are being treated with Damoctocog alfa pegol (Jivi, BAY94-9027) in routine medical practice and are enrolled in Bayer-sponsored study NCT03932201
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Damoctocog alfa pegol (Jivi, BAY94-9027)
2019
Completed Phase 4
~40
Find a Location
Who is running the clinical trial?
BayerLead Sponsor
2,245 Previous Clinical Trials
25,333,184 Total Patients Enrolled
60 Trials studying Hemophilia A
5,632 Patients Enrolled for Hemophilia A
Frequently Asked Questions
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