xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05981274</url>
    </required_header>
    <id_info>
      <org_study_id>A202305097</org_study_id>
      <nct_id>NCT05981274</nct_id>
    </id_info>
    <brief_title>A Study on the Bone-health Effectiveness of Applying Recombinant Factor VIII Fc (rFVIIIFc) to Patients With Hemophilia A (Prototype A)</brief_title>
    <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)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Tri-Service General Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Tri-Service General Hospital</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Study Objectives*&#xD;
  &#xD;
          1. Provide a systematic evaluation of the treatment outcomes in patients with hemophilia A&#xD;
  &#xD;
          2. Emphasize the importance and clinical benefits of rFVIII-Fc in joint and bone health.&#xD;
  &#xD;
          3. Compare the clinical outcomes from 1 year before and after switching to EHL.&#xD;
  &#xD;
          4. Exploratory: Identify biomarkers that could provide more useful and convenient&#xD;
             evaluations of joint and bone health. (Time-saving and easy to monitor)&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In this study, we would like to focus on the evaluation of joint and bone health in persons&#xD;
        with severe hemophilia A (PwHA) treated with rFVIIIFc prophylaxis. We also aim to identify&#xD;
        potential biomarkers for assessing the joint and bone health of PwHA. Since the joint and&#xD;
        bone health examinations are time-consuming, expensive, and require special equipment, the&#xD;
        patients could only receive the examinations annually to realize the status of their joint&#xD;
        health. The biomarkers testing will provide a more convenient and time-saving option on the&#xD;
        joint and bone health evaluation for PwHA. Therefore, surrogate of biochemical marker(s) to&#xD;
        represent the joint and BMD progression is an unmet need for clinical practice. Investigating&#xD;
        different biomarkers and combining them with the joint and BMD results to provide a&#xD;
        systematic approach for elucidating the treatment outcomes of PwHA treated with rFVIIIFc is&#xD;
        major goal of this study.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 11, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2027</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2027</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Other</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Systematic joint and bone health assessments before and after enrollment</measure>
      <time_frame>up to 5 years</time_frame>
      <description>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.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Serum markers</measure>
      <time_frame>up to 5 years</time_frame>
      <description>CTX-II, COMP, HSCRP, TNF-ALPHA, CTX-I, SRANKL, OPG, OPN</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">45</enrollment>
    <condition>Severe Hemophilia A Without Inhibitor</condition>
    <arm_group>
      <arm_group_label>Systematic joint and bone health assessments before and after enrollment</arm_group_label>
      <description>Haemophilia Early Arthropathy Detection :HEAD-US, HJHS, and DEXA scan&#xD;
  serum markers : CTX-II, COMP, hsCRP, TNF-a, CTX-I, sRANKL, OPG, and Osteopontin (OPN)&#xD;
  Quality of life assessments (Haem-A-QoL, EQ-5D)</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>serum biomarker.</intervention_name>
      <description>serum biomarker:CTX-II, COMP, hsCRP, TNF-a, CTX-I, sRANKL, OPG, and Osteopontin (OPN)</description>
      <arm_group_label>Systematic joint and bone health assessments before and after enrollment</arm_group_label>
    </intervention>
    <biospec_retention>Samples Without DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Blood samples (serum) will be obtained for serum markers.&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          severe hemophilia A patients or moderate hemophilia A patients with hemophilic arthropathy.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Patients with severe hemophilia A (all ages).&#xD;
  &#xD;
            2. Patients with moderate type hemophilia A with hemophilic arthropathy.&#xD;
  &#xD;
            3. Currently on rFVIIIFc regular prophylaxis and have previous medical record with&#xD;
               regular prophylaxis with standard half-life product for one year&#xD;
  &#xD;
            4. Able and willing to undergo joint and bone examinations&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Participants of other interventional studies.&#xD;
  &#xD;
            2. Patients with current inhibitors.&#xD;
  &#xD;
            3. History of major neurological disease (eg. Stroke, Parkinson's disease, neuropathy,&#xD;
               etc.)&#xD;
  &#xD;
            4. History of major psychiatric disease (eg. Schizophrenia, bipolar disorder)&#xD;
  &#xD;
            5. Significantly impaired vision/hearing&#xD;
        </textblock>
      </criteria>
      <gender>Male</gender>
      <gender_based>Yes</gender_based>
      <gender_description>Males with one affected X chromosome is defined hemophilia disease; a female with one affected X chromosome is a &quot;carrier&quot; of hemophilia.</gender_description>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Yeu-Chin Chen</last_name>
      <phone>(+886)2-87923311</phone>
      <phone_ext>13654</phone_ext>
      <email>yeuchin99@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Tri-Service General Hospital Hemophilia Care Center</name>
        <address>
          <city>Taipei</city>
          <state>Neihu Dist.</state>
          <zip>114202</zip>
          <country>Taiwan</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Yeu-Chin chen</last_name>
        <phone>(+886)2-87923311</phone>
        <phone_ext>13654</phone_ext>
        <email>yeuchin99@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Taiwan</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 17, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Tri-Service General Hospital</investigator_affiliation>
      <investigator_full_name>Chen Yeu-Chin</investigator_full_name>
      <investigator_title>Director of the Hemophilia Center</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hemophilia A</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05981274
  org study id: A202305097
  nct id: NCT05981274
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  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)
  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.
  observational model: Other
  time perspective: Other
  measure: Systematic joint and bone health assessments before and after enrollment
  time frame: up to 5 years
  description: 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.
  measure: Serum markers
  time frame: up to 5 years
  description: CTX-II, COMP, HSCRP, TNF-ALPHA, CTX-I, SRANKL, OPG, OPN
  arm group label: Systematic joint and bone health assessments before and after enrollment
  description: Haemophilia Early Arthropathy Detection :HEAD-US, HJHS, and DEXA scan
  serum markers : CTX-II, COMP, hsCRP, TNF-a, CTX-I, sRANKL, OPG, and Osteopontin (OPN)
  Quality of life assessments (Haem-A-QoL, EQ-5D)
  intervention type: Diagnostic Test
  intervention name: serum biomarker.
  description: serum biomarker:CTX-II, COMP, hsCRP, TNF-a, CTX-I, sRANKL, OPG, and Osteopontin (OPN)
  arm group label: Systematic joint and bone health assessments before and after enrollment
  Blood samples (serum) will be obtained for serum markers.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: Male
  gender based: Yes
  gender description: Males with one affected X chromosome is defined hemophilia disease; a female with one affected X chromosome is a "carrier" of hemophilia.
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Yeu-Chin Chen
  phone: (+886)2-87923311
  phone ext: 13654
  email: yeuchin99@gmail.com
  facility: 
  status: Recruiting
  contact: 
  country: Taiwan
  responsible party type: Principal Investigator
  investigator affiliation: Tri-Service General Hospital
  investigator full name: Chen Yeu-Chin
  investigator title: Director of the Hemophilia Center
  mesh term: Hemophilia A
  sharing ipd: No