Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00000556

Trial Description

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Title

ADVATE / ADYNOVI Hemophilia A Outcome Database

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Trial Acronym

AHEAD

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Non-interventional study with subjects and hemophilia A receiving the product ADVATE or ADYNOVI as routine-treatment. Documentation of those patients concerning quality of life, co-morbidity, drug utilization, effectiveness and safety of the product ADVATE and ADYNOVI will be assessed.

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Brief Summary in Scientific Language

Documentation and comparison of long-term outcomes of subjects with hemophilia A receiving ADVATE or ADYNOVI in routine clinical practice in terms of quality of life, hemophilia-related co-morbidity, drug utilization, effectiveness and safety.

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Do you plan to share individual participant data with other researchers?

No

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Description IPD sharing plan:

[---]*

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Organizational Data

  •   DRKS00000556
  •   2010/09/23
  •   [---]*
  •   no
  •   Approved
  •   260/09, Ethik-Kommission der Medizinischen Fakultät der Rheinischen Friedrich-Wilhelms-Universität Bonn
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   D66 -  Hereditary factor VIII deficiency
  •   [---]* -  [---]*
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Interventions/Observational Groups

  • [---]*
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Prognosis
  •   Single (group)
  •   N/A
  •   [---]*
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Primary Outcome

Incidence of haemophilia-affected joint-arthropathy by imaging techniques (e.g. MRI, X-ray, ultrasound) and by assessment of the treating physician using only the pain, bleeding, and physical exam parameter of the Gilbert Scale.

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Secondary Outcome

Incidence of joint replacement therapies; incidence of target joint operations; Incidence of pseudo-tumor development; Pain associated with bleeding event according to VAS-Score; Quality of life using the Haemo-QoL, SF-10TM, SF-12v2TM and Haem-A-QoL questionnaires; Annualized bleed rate; Hemostatic effectiveness rating of bleeding episodes treated with ADVATE or ADYNOVI; Number of units required for bleed resolution; Number of infusions required for bleed resolution; Number of days off from school or work due to hemophilia A bleeding episodes; Incidence of inhibitors in PTPs; Incidence of inhibitors in PUPs; Incidence of inhibitors after switching to ADYNOVI; Incidence of treatment-related serious AEs; Incidence of treatment-related non-serious AEs; Compliance with the dosing prescribed and its relationship with effectiveness in prophylaxis regimen; Modalities of switching from a standard FVIII product to ADYNOVI (prophylaxis regimen)
- Difference in number of weekly prophylactic infusions between previous regimen and ADYNOVI
- Difference in number of weekly doses between previous regimen and ADYNOVI;
Status of joint health using the Hemophilia Joint Health Score (HJHS) in patients on ADYNOVI

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2010/06/07
  •   500
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   no maximum age
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Additional Inclusion Criteria

Subject has moderate or severe hemophilia A (baseline factor VIII < 5%) and is being treated with ADVATE or ADYNOVI on any treatment regimen recommended by his/her treating physician. Subject, parent(s) or legally authorized representative has provided written informed consent. For ADYNOVI: Subject aged ≥ 12 years

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Exclusion Criteria

Subject has known hypersensitivity to the active substance or to any of the excipients. Subject has a known allergic reaction to mouse or hamster proteins.

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Addresses

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    • Takeda Pharma Vertrieb GmbH & Co. KG
    • Jägerstr. 27
    • 10117   Berlin
    • Germany
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    •   +49-30 20658 220
    •   +49-30 20658 22100
    •   [---]*
    •   [---]*
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    • Takeda Pharma Vertrieb GmbH & Co. KG
    • Mr.  Dr. med.   Stephan   Regensburger 
    • Friedrichstraße 149
    • 10117   Berlin
    • Germany
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    • Takeda Pharma Vertrieb GmbH & Co. KG
    • Mr.  Dr. med.   Stephan   Regensburger 
    • Friedrichstraße 149
    • 10117   Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Takeda Pharma Vertrieb GmbH & Co. KG
    • Jägerstr. 27
    • 10117   Berlin
    • Germany
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    •   +49-30 20658 20
    •   +49-30 20658 2110
    •   [---]*
    •   [---]*
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.