Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04091386
Other study ID # 20748
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date June 10, 2021
Est. completion date June 30, 2027

Study information

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

Clinical 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.


Description:

The primary objective is to evaluate the change in physical non-sedentary activity as measured by the ActiGraph CentrePoint Insight Watch (ActiGraph LLC, Pensacola, Florida) after 1, 2 and 3 years of treatment with damoctocog alfa pegol. Secondary objectives are to determine the - Change in intensity of physical activity, - Association between physical activities and clinical outcomes / patient-reported outcome scores/ number of bleeds, - Percentage of patients achieving WHO-recommended levels of activity - Actual wear time.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 7
Est. completion date June 30, 2027
Est. primary completion date December 31, 2026
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Enrolled in the HEM-POWR study (NCT03932201) - Naïve to damoctocog alfa pegol prior to enrollment to HEM-POWR study - Prescribed for prophylaxis treatment for hemophilia with damoctocog alfa pegol - Patient is willing to wear the provided device - Signed informed consent/assent to participate in LIFE-ACTIVE: Observational study evaluating the physical activity in a subset of damoctocog alfa pegol treated Hemophilia A patients who are enrolled in the HEM-POWR study Exclusion Criteria: - Hypersensitivity to any material of activity monitor (e.g. steel, rubber) - Time gap between enrollment to HEM-POWR study and enrollment to LIFE-ACTIVE study is greater than 6 months

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Damoctocog alfa pegol (Jivi, BAY94-9027)
Intervention is given as part of routine medical practice

Locations

Country Name City State
Belgium Many Locations Multiple Locations
Canada Many Locations Multiple Locations
Italy Many Locations Multiple Locations
Slovenia Many Locations Multiple Locations
Spain Many Locations Multiple Locations
Taiwan Many Locations Multiple Locations
United States Tulane University New Orleans Louisiana
United States Center for Comprehensive Care and Diagnosis of Inherited Blood Disorders Orange California

Sponsors (1)

Lead Sponsor Collaborator
Bayer

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  Italy,  Slovenia,  Spain,  Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time of physical non-sedentary activity per week 30 days at baseline
Primary Time of physical non-sedentary activity per week 30 days at year 1
Primary Time of physical non-sedentary activity per week 30 days at year 2
Primary Time of physical non-sedentary activity per week 30 days at year 3
Primary Category of physical non-sedentary activity The intensity of physical activity are: combined moderate to vigorous intensity, light intensity, moderate intensity, and vigorous intensity 30 days at baseline
Primary Category of physical non-sedentary activity The intensity of physical activity are: combined moderate to vigorous intensity, light intensity, moderate intensity, and vigorous intensity 30 days at year 1
Primary Category of physical non-sedentary activity The intensity of physical activity are: combined moderate to vigorous intensity, light intensity, moderate intensity, and vigorous intensity 30 days at year 2
Primary Category of physical non-sedentary activity The intensity of physical activity are: combined moderate to vigorous intensity, light intensity, moderate intensity, and vigorous intensity 30 days at year 3
Secondary Time of physical activity per week by intensity Intensity categories of physical activity are: combined moderate to vigorous intensity, light intensity, moderate intensity, and vigorous intensity 30 days at each visit (baseline, year 1, 2 and 3)
Secondary Time of physical activity per week by intensity stratified by sedentary and locomotion activity Intensity categories of physical activity are: combined moderate to vigorous intensity, light intensity, moderate intensity, and vigorous intensity. Sedentary = yes/no; locomotion = yes/no 30 days at each visit (baseline, year 1, 2 and 3)
Secondary Association between physical activity time per week and annualized bleeding rate (ABR) ABR from HEM-POWR study 30 days at each visit (baseline, year 1, 2 and 3)
Secondary Association between physical activity time per week and joint annualized bleeding rate (JABR) JABR from HEM-POWR study 30 days at each visit (baseline, year 1, 2 and 3)
Secondary Association between physical activity time per week and hemophilia joint health score (HJHS) HJHS from HEM-POWR study 30 days at each visit (baseline, year 1, 2 and 3)
Secondary Association between physical activity time per week and PRO-scores for treatment satisfaction Patient reported outcome (PRO) scores from the Hemophilia Treatment Satisfaction Questionnaire for Adults collected in HEM-POWR study 30 days at each visit (baseline, year 1, 2 and 3)
Secondary Association between physical activity time per week and PRO-scores for health-related life quality Patient reported outcome (PRO) scores from the Hemophilia Quality Life Measures for adults and Hemophilia Quality of Life short form for children questionnaires collected in HEM-POWR study 30 days at each visit (baseline, year 1, 2 and 3)
Secondary Association between physical activity time per week and PRO-scores for work productivity/ activity impairment Patient reported outcome (PRO) scores from the Work Productivity and Activity Impairment Scale questionnaire collected in HEM-POWR study 30 days at each visit (baseline, year 1, 2 and 3)
Secondary Percentage of children (under 18) with =60 min per day of moderate to vigorous intensity physical activity 30 days at each visit (baseline, year 1, 2 and 3)
Secondary Percentage of adults (age 18 to 64) with =150 min per week of moderate to vigorous intensity physical activity or with =75 min per week of vigorous intensity physical activity 30 days at each visit (baseline, year 1, 2 and 3)
Secondary Repeated measure correlation between change in amount of non-sedentary physical activity time per week and change in annualized bleeding rate (ABR) ABR from HEM-POWR study 30 days at each visit (baseline, year 1, 2 and 3)
Secondary Repeated measure correlation between change in amount of non-sedentary physical activity time per week and change in joint annualized bleeding rate (JABR) JABR from HEM-POWR study 30 days at each visit (baseline, year 1, 2 and 3)
Secondary Actual wear time per week 30 days at each visit (baseline, year 1, 2 and 3)
Secondary Percentage of actual wear time per week 30 days at each visit (baseline, year 1, 2 and 3)
See also
  Status Clinical Trial Phase
Completed NCT03834727 - Characterizing the Impact and Treatment of Reproductive Tract Bleeding on Women and Post-menarchal Girls With Bleeding Disorders
Completed NCT03191799 - A Study to Evaluate the Safety and Tolerability of Prophylactic Emicizumab in Hemophilia A Patients With Inhibitors Phase 3
Completed NCT01599819 - BAX 855 Dose-Escalation Safety Study Phase 1
Terminated NCT04541628 - Safety & Efficacy of Encapsulated Allogeneic FVIII Cell Therapy in Haemophilia A Phase 1/Phase 2
Completed NCT02847637 - A Clinical Trial to Evaluate Prophylactic Emicizumab Versus no Prophylaxis in Hemophilia A Participants Without Inhibitors Phase 3
Completed NCT04072237 - Study of Coagulation Faction VIIa Variant Marzeptacog Alfa (Activated) in Adult Subjects With Hemophilia Phase 1
Completed NCT04085458 - Study to Gain More Information on How Safe and Effective Jivi Works in Patients With Severe Hemophilia A (Post-marketing Investigation) Phase 4
Completed NCT04565236 - A Post Approval Commitment Study to Gain More Information on How Safe and Effective KOVALTRY is in Chinese Children, Adolescents /Adults With Severe Hemophilia A Phase 4
Recruiting NCT05987449 - A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of NXT007 in Persons With Severe or Moderate Hemophilia A Phase 1/Phase 2
Active, not recruiting NCT04621916 - Preventing Inhibitor Recurrence Indefinitely Phase 4
Not yet recruiting NCT02888223 - Pharmacokinetic Study of SCT800 in Previously Treated Patients With Hemophilia A Phase 1
Completed NCT02528968 - National Study of a Pharmacokinetic-Focused Educational Package for Patients With Severe Haemophilia A N/A
Completed NCT02225483 - Phenotypic Heterogeneity in Hemophilia A: An Investigation of the Role of Platelet Function N/A
Completed NCT02199717 - An Institutional Pilot Study to Investigate Physical Activity Patterns in Boys With Hemophilia N/A
Completed NCT01217255 - Comparing the Burden of Illness of Hemophilia in the Developing and the Developed World
Completed NCT00969319 - Effekt-2 - Efficacy and Safety of Long-term Treatment With KOGENATE® FS in Latin America N/A
Terminated NCT00995046 - Individually Tailored Prophylaxis in Patients With Severe Hemophilia A N/A
Completed NCT00868530 - Study Evaluating On-Demand Treatment Of Xyntha In Chinese Subjects Phase 3
Completed NCT00839202 - Activity and Content of Factor VIII (FVIII) in Human Plasma: The Assessment of a Novel Immunoassay N/A
Completed NCT00629837 - Pharmacokinetics and Safety of a Single Intravenous Infusion of BAY 79-4980 Phase 1