A Study on the Bone-health Effectiveness of Applying Recombinant Factor VIII Fc (rFVIIIFc) to Patients With Hemophilia A (Prototype A)
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ClinicalTrials.gov Identifier: NCT05981274 |
Recruitment Status :
Recruiting
First Posted : August 8, 2023
Last Update Posted : April 10, 2024
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Study Objectives*
- Provide a systematic evaluation of the treatment outcomes in patients with hemophilia A
- Emphasize the importance and clinical benefits of rFVIII-Fc in joint and bone health.
- Compare the clinical outcomes from 1 year before and after switching to EHL.
- Exploratory: Identify biomarkers that could provide more useful and convenient evaluations of joint and bone health. (Time-saving and easy to monitor)
Condition or disease | Intervention/treatment |
---|---|
Severe Hemophilia A Without Inhibitor | Diagnostic Test: serum biomarker. |
Study Type : | Observational |
Estimated Enrollment : | 45 participants |
Observational Model: | Other |
Time Perspective: | Other |
Official Title: | 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) |
Actual Study Start Date : | July 14, 2023 |
Estimated Primary Completion Date : | December 31, 2027 |
Estimated Study Completion Date : | December 31, 2027 |
Group/Cohort | Intervention/treatment |
---|---|
Systematic joint and bone health assessments before and after enrollment
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Diagnostic Test: serum biomarker.
serum biomarker:CTX-II, COMP, hsCRP, TNF-a, CTX-I, sRANKL, OPG, and Osteopontin (OPN) |
- Systematic joint and bone health assessments before and after enrollment [ Time Frame: up to 5 years ]Haemophilia Early Arthropathy Detection with Ultrasound (HEAD-US) on patients' ankles, knees, and elbows. Also evaluate the Hemophilia Joint Health Score (HJHS) and Dexa scan at the hip.
- Serum markers [ Time Frame: up to 5 years ]CTX-II, COMP, HSCRP, TNF-ALPHA, CTX-I, SRANKL, OPG, OPN
Biospecimen Retention: Samples Without DNA
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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | Male |
Gender Based Eligibility: | Yes |
Gender Eligibility Description: | Males with one affected X chromosome is defined hemophilia disease; a female with one affected X chromosome is a "carrier" of hemophilia. |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- 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
Exclusion Criteria:
- Participants of other interventional studies.
- Patients with current inhibitors.
- History of major neurological disease (eg. Stroke, Parkinson's disease, neuropathy, etc.)
- History of major psychiatric disease (eg. Schizophrenia, bipolar disorder)
- Significantly impaired vision/hearing
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05981274
Contact: Yeu-Chin Chen | (+886)2-87923311 ext 13654 | yeuchin99@gmail.com |
Taiwan | |
Tri-Service General Hospital Hemophilia Care Center | Recruiting |
Taipei, Neihu Dist., Taiwan, 114202 | |
Contact: Yeu-Chin chen (+886)2-87923311 ext 13654 yeuchin99@gmail.com |
Responsible Party: | Chen Yeu-Chin, Director of the Hemophilia Center, Tri-Service General Hospital |
ClinicalTrials.gov Identifier: | NCT05981274 |
Other Study ID Numbers: |
A202305097 |
First Posted: | August 8, 2023 Key Record Dates |
Last Update Posted: | April 10, 2024 |
Last Verified: | July 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Hemophilia A Blood Coagulation Disorders, Inherited Blood Coagulation Disorders Hematologic Diseases |
Coagulation Protein Disorders Hemorrhagic Disorders Genetic Diseases, Inborn |