A Prospective and Retrospective Interventional Study on the Bone-health Effectiveness of Applying Recombinant Factor VIII Fc (rFVIIIFc) to Patients With Hemophilia A (Prototype A)

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
SUMMARY

Study Objectives\* 1. Provide a systematic evaluation of the treatment outcomes in patients with hemophilia A 2. Emphasize the importance and clinical benefits of rFVIII-Fc in joint and bone health. 3. Compare the clinical outcomes from 1 year before and after switching to EHL. 4. Exploratory: Identify biomarkers that could provide more useful and convenient evaluations of joint and bone health. (Time-saving and easy to monitor)

Eligibility
Participation Requirements
Sex: Male
Healthy Volunteers: t
View:

• Patients with severe hemophilia A (all ages).

• Patients with moderate type hemophilia A with hemophilic arthropathy.

• Currently on rFVIIIFc regular prophylaxis and have previous medical record with regular prophylaxis with standard half-life product for one year

• Able and willing to undergo joint and bone examinations

Locations
Other Locations
Taiwan
Tri-Service General Hospital Hemophilia Care Center
RECRUITING
Taipei
Contact Information
Primary
Yeu-Chin Chen
yeuchin99@gmail.com
(+886)2-87923311
Time Frame
Start Date: 2023-07-14
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 45
Treatments
Systematic joint and bone health assessments before and after enrollment
1. Haemophilia Early Arthropathy Detection :HEAD-US, HJHS, and DEXA scan~2. serum markers : CTX-II, COMP, hsCRP, TNF-a, CTX-I, sRANKL, OPG, and Osteopontin (OPN)~3. Quality of life assessments (Haem-A-QoL, EQ-5D)
Related Therapeutic Areas
Sponsors
Leads: Tri-Service General Hospital

This content was sourced from clinicaltrials.gov