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NCT Number: NCT02319070

2-cohort Study of Adult Patients With Severe Hemophilia A in Greece

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.

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Key information

Conditions

Hemophilia A Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Multiple Locations, Greece

About this study

The primary therapy for hemophilia is coagulation factor replacement, given either episodically on demand (OD) for the treatment of acute bleeds or prophylactically to prevent them.

The last years there has been an interest to study the comparative effectiveness of OD vs. SP (Secondary Prophylaxis) treatment strategies so as to create an evidence based platform to guide both clinical decision making and quantify the economic aspects of each treatment alternative. In Greece relevant information is lacking, thus it is imperative to study how patients on different treatment strategies are managed in a real-life setting in Greece, including the main factors associated with increased health care utilization, clinical success and patient well being.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Survey

Other

Recombinant antihemophilic factor VIII (FVIII) on Secondary Prophylaxis treatment scheduled according to daily routine

Primary outcomes

  1. Annual direct medical cost of specialized hemophilia centre for patients with the on-demand strategy

    Time frame: At 18 months

  2. Annual direct medical cost of specialized hemophilia centre for patients with secondary prophylaxis

    Time frame: At 18 months

Secondary outcomes

  1. Mean cost per joint bleed episodes for overall patients

    Time frame: At 18 months

  2. Mean cost per joint bleed episodes by cohort for patients

    Time frame: At 18 months

  3. Number of joint bleed episodes for overall patients

    Time frame: At 18 months

  4. Number of joint bleed episodes by cohort for patients.

    Time frame: At 18 months

  5. Severity of joint bleed episodes for overall patients.

    Time frame: At 18 months

  6. Severity of joint bleed episodes by cohort for patients.

    Time frame: At 18 months

  7. Mean EQ-VAS score as reported from patients at the time of a major bleed.

    Time frame: At 18 months

    EQ-VAS score is Standardized questionnaire for hemophilia

  8. Mean EQ-5D score as reported from patients at the time of a major bleed.

    Time frame: At 18 months

    EQ-5D The EuroQol standardized instrument of health outcome

  9. Mean change from baseline in Quality of Life scores derived from the Haem-A-Qol and EQ-5D questionnaires

    Time frame: Baseline and at 18 months

    Haem-A-Qol Specific questionnaire for hemophilia and EQ-5D The EuroQol standardized instrument of health outcome

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Acronym: HAMLET

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Dec 18, 2014
Registry last updated
Jun 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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