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

Hemophilia A Clinical Trial

— HAMLET  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02319070
• Other study ID #: 17493
• Secondary ID: KG1411GR
• Status: Completed
• Start date: January 13, 2015
• Est. completion date: February 28, 2018

Study information

• Verified date: June 2018
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: February 28, 2018
• Est. primary completion date: May 28, 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hemophilia A

Intervention

Other:
• Survey
Recombinant antihemophilic factor VIII (FVIII) on Secondary Prophylaxis treatment scheduled according to daily routine
• Survey
Recombinant antihemophilic factor VIII (FVIII) On Demand treatment scheduled according to daily routine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Annual direct medical cost of specialized hemophilia centre for patients with the on-demand strategy		At 18 months
Primary	Annual direct medical cost of specialized hemophilia centre for patients with secondary prophylaxis		At 18 months
Secondary	Mean cost per joint bleed episodes for overall patients		At 18 months
Secondary	Mean cost per joint bleed episodes by cohort for patients		At 18 months
Secondary	Number of joint bleed episodes for overall patients		At 18 months
Secondary	Number of joint bleed episodes by cohort for patients.		At 18 months
Secondary	Severity of joint bleed episodes for overall patients.		At 18 months
Secondary	Severity of joint bleed episodes by cohort for patients.		At 18 months
Secondary	Mean EQ-VAS score as reported from patients at the time of a major bleed.	EQ-VAS score is Standardized questionnaire for hemophilia	At 18 months
Secondary	Mean EQ-5D score as reported from patients at the time of a major bleed.	EQ-5D The EuroQol standardized instrument of health outcome	At 18 months
Secondary	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	Baseline and at 18 months

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