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Observational Study of Long-Term Joint Health Outcome in Hemophilia Patient

UnknownN/A

Sponsor: Taipei Medical University Hospital

Conditions: Hemophilia, Arthropathy

Countries: Taiwan

Patients with severe hemophilia A can experience repeated bleeding into the same joint (ie, a target joint; most frequently in the ankle, knee, and elbow), which can contribute to hemophilic arthropathy and, over time, ultimately result in chronic pain, functional limitations, deformities, reduced joint of motion and decreased quality of life. Early use of prophylaxis is recommended following diagnosis of severe hemophilia A to maintain joint health and prevent joint destruction. Eloctate is produced using a human cell line and an addition of an Fc fusion protein to recombinant FVIII (rFVIIIFc) with prolonged half-life and was launched in Taiwan from Nov. 2018. The pivotal studies of rFVIIIFc show that patients maintained a low bleeding rate, with most experiencing a median annualized bleeding rate (ABR) of 0 and 97% of target joints were resolved across adult, adolescent, and pediatric subjects during 4 years of prophylaxis rFVIIIFc treatment. However, in Taiwan we are still lacking the real world treatment outcome data on rFVIIIFc, especially for the joint health evidence in Asian Hemophilia A patients. Therefore the objective of this study is to evaluate the effectiveness of rFVIIIFc treatment on joint health over a long observational period of 36 month focused on physical and functional changes in hemophilia A patients.

Eligibility overview

Sex: ALL

Age: 20 Years to 75 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

1. Willing to sign inform consent form and complied with study procedure
2. Patient received confirmative diagnosis of Hemophilia A Disease
3. Severe hemophilia A patient currently who are on treatment with Eloctate prior to enrolment visit (Note: Prescription based on physician's clinical judgement and discussion with patients)

Exclusion Criteria:

1. Unwilling to sign inform consent form.
2. History of major neurological disease (eg. Stroke, Parkinson's disease, neuropathy, etc.)
3. History of major psychiatric disease (eg. Schizophrenia, bipolar disorder)
4. Significantly impaired vision / hearing
5. Cannot communicate in Mandarin Chinese
6. Recent joint bleeding and trauma 3 months prior to study

Locations (1)

Taipei, Taiwan