check_circleStudy Completed

Hemophilia A

Bayer Identifier:

17493

ClinicalTrials.gov Identifier:

NCT02319070

EudraCT Number:

Not Available

EU CT Number:

Not Available
2-cohort study of adult patients with severe Hemophilia A in Greece

Trial purpose

This study is a prospective, single center, observational, 2-cohort study of adult patients with severe Hemophilia A. There is no randomization procedure and all patients will be treated as per usual clinical practice. Patients will be followed up for 18 months after enrolment.

Key Participants Requirements

Sex

Male

Age

18 - N/A
  • - Patients diagnosed with severe Hemophilia A.
    - Age ≥18 years old
    - Patients able to read and write
    - Patients receiving Factor VIII substitute therapy, either on-demand or as secondary prophylaxis.
    - Patients under the same therapeutic strategy (On Demand or Secondary Prophylaxis) for at least 6 months prior to enrolment.

  • - Patients that have developed inhibitors against factor VIII.
    - Patients participating in an investigational program with interventions outside of routine clinical practice.

Trial summary

Enrollment Goal
72
Trial Dates
January 2015 - February 2018
Phase
N/A
Could I Receive a placebo
No
Products
Kogenate FS (Recombinant Factor VIII, BAY14-2222)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
many locations, Greece

Primary Outcome

  • Annual direct medical cost of specialized hemophilia centre for patients with the on-demand strategy
    date_rangeTime Frame:
    At 18 months
    enhanced_encryption
    Safety Issue:
    No
  • Annual direct medical cost of specialized hemophilia centre for patients with secondary prophylaxis
    date_rangeTime Frame:
    At 18 months
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Mean cost per joint bleed episodes for overall patients
    date_rangeTime Frame:
    At 18 months
    enhanced_encryption
    Safety Issue:
    No
  • Mean cost per joint bleed episodes by cohort for patients
    date_rangeTime Frame:
    At 18 months
    enhanced_encryption
    Safety Issue:
    No
  • Number of joint bleed episodes for overall patients
    date_rangeTime Frame:
    At 18 months
    enhanced_encryption
    Safety Issue:
    No
  • Number of joint bleed episodes by cohort for patients.
    date_rangeTime Frame:
    At 18 months
    enhanced_encryption
    Safety Issue:
    No
  • Severity of joint bleed episodes for overall patients.
    date_rangeTime Frame:
    At 18 months
    enhanced_encryption
    Safety Issue:
    No
  • Severity of joint bleed episodes by cohort for patients.
    date_rangeTime Frame:
    At 18 months
    enhanced_encryption
    Safety Issue:
    No
  • Mean EQ-VAS score as reported from patients at the time of a major bleed.
    EQ-VAS score is Standardized questionnaire for hemophilia
    date_rangeTime Frame:
    At 18 months
    enhanced_encryption
    Safety Issue:
    No
  • Mean EQ-5D score as reported from patients at the time of a major bleed.
    EQ-5D The EuroQol standardized instrument of health outcome
    date_rangeTime Frame:
    At 18 months
    enhanced_encryption
    Safety Issue:
    No
  • Mean change from baseline in Quality of Life scores derived from the Haem-A-Qol and EQ-5D questionnaires
    Haem-A-Qol Specific questionnaire for hemophilia and EQ-5D The EuroQol standardized instrument of health outcome
    date_rangeTime Frame:
    Baseline and at 18 months
    enhanced_encryption
    Safety Issue:
    No

Trial design

Prospective, observational, 2-cohort study of adult patients with severe Hemophilia A in Greece. Cost,clinical outcomes and quality of life comparison between on demand and secondary prophylaxis treatment strategies
Trial Type
Observational
Intervention Type
Other
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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