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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-14

Study Completion Date

2027-12-31

Brief Summary

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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)

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Detailed Description

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In this study, we would like to focus on the evaluation of joint and bone health in persons with severe hemophilia A (PwHA) treated with rFVIIIFc prophylaxis. We also aim to identify potential biomarkers for assessing the joint and bone health of PwHA. Since the joint and bone health examinations are time-consuming, expensive, and require special equipment, the patients could only receive the examinations annually to realize the status of their joint health. The biomarkers testing will provide a more convenient and time-saving option on the joint and bone health evaluation for PwHA. Therefore, surrogate of biochemical marker(s) to represent the joint and BMD progression is an unmet need for clinical practice. Investigating different biomarkers and combining them with the joint and BMD results to provide a systematic approach for elucidating the treatment outcomes of PwHA treated with rFVIIIFc is major goal of this study.

Conditions

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Severe Hemophilia A Without Inhibitor

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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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)

serum biomarker.

Intervention Type DIAGNOSTIC_TEST

serum biomarker:CTX-II, COMP, hsCRP, TNF-a, CTX-I, sRANKL, OPG, and Osteopontin (OPN)

Interventions

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serum biomarker.

serum biomarker:CTX-II, COMP, hsCRP, TNF-a, CTX-I, sRANKL, OPG, and Osteopontin (OPN)

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

1. Patients with severe hemophilia A (all ages).
2. Patients with moderate type hemophilia A with hemophilic arthropathy.
3. Currently on rFVIIIFc regular prophylaxis and have previous medical record with regular prophylaxis with standard half-life product for one year
4. Able and willing to undergo joint and bone examinations

Exclusion Criteria

1. Participants of other interventional studies.
2. Patients with current inhibitors.
3. History of major neurological disease (eg. Stroke, Parkinson's disease, neuropathy, etc.)
4. History of major psychiatric disease (eg. Schizophrenia, bipolar disorder)
5. Significantly impaired vision/hearing

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes