Trial Condition(s):
Hemophilia A
2-cohort study of adult patients with severe Hemophilia A in Greece (HAMLET)
Bayer Identifier:
17493
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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.
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.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Investigative Site many locations, Greece | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
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:
2
Primary Outcome
- Annual direct medical cost of specialized hemophilia centre for patients with the on-demand strategyTimeframe: At 18 months
- Annual direct medical cost of specialized hemophilia centre for patients with secondary prophylaxisTimeframe: At 18 months
Secondary Outcome
- Mean cost per joint bleed episodes for overall patientsTimeframe: At 18 months
- Mean cost per joint bleed episodes by cohort for patientsTimeframe: At 18 months
- Number of joint bleed episodes for overall patientsTimeframe: At 18 months
- Number of joint bleed episodes by cohort for patients.Timeframe: At 18 months
- Severity of joint bleed episodes for overall patients.Timeframe: At 18 months
- Severity of joint bleed episodes by cohort for patients.Timeframe: At 18 months
- Mean EQ-VAS score as reported from patients at the time of a major bleed.EQ-VAS score is Standardized questionnaire for hemophiliaTimeframe: At 18 months
- Mean EQ-5D score as reported from patients at the time of a major bleed.EQ-5D The EuroQol standardized instrument of health outcomeTimeframe: At 18 months
- Mean change from baseline in Quality of Life scores derived from the Haem-A-Qol and EQ-5D questionnairesHaem-A-Qol Specific questionnaire for hemophilia and EQ-5D The EuroQol standardized instrument of health outcomeTimeframe: Baseline and at 18 months
Additional Information
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