CompletedNCT02319070HAMLETUpdated Jun 20, 2018

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

An observational study in Hemophilia A, sponsored by Bayer. Completed at 1 site in Greece. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-06-20.

Study 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.

Read the detailed 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.

Conditions studied

Hemophilia A

Browse trials for

Hemophilia A 885

Keywords

Cost
Clinical Outcomes
Quality of Life
On Demand Treatment
Secondary Prophylaxis

In context

Hemophilia A

885 studies on the registry are indexed under Hemophilia A; 139 are open to participants now.

This study's enrollment of 72 is close to the median of 80 across 322 observational studies indexed under Hemophilia A.

Browse Hemophilia A studies →

Lead sponsor

Bayer is the lead sponsor of 1,674 studies on the registry; 54 are open to participants now.

Of its 213 completed or terminated interventional studies of FDA-regulated products, 130 (61%) have results posted.

Browse Bayer studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: Male
Accepts healthy volunteers: No
Sampling method: Probability sample

Study population

This will be a single center prospective two-cohort observational study conducted in a hospital setting.Patients will be enrolled from the biggest specialty management center in Greece

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

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

Study design

Observational model: Cohort
Time perspective: Prospective
Enrollment: 72 participants (actual)

Groups and cohorts

Cohort 1
Adult patients with severe Hemophilia A.(25 patients on Secondary Prophylaxis treatment)
Other: Survey
Cohort 2
Adult patients with severe Hemophilia A.(50 patients on On Demand treatment)
Other: Survey

Interventions

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

What researchers measure

Primary outcomes

Annual direct medical cost of specialized hemophilia centre for patients with the on-demand strategy
Time frame: At 18 months
Annual direct medical cost of specialized hemophilia centre for patients with secondary prophylaxis
Time frame: At 18 months

Secondary outcomes

Mean cost per joint bleed episodes for overall patients
Time frame: At 18 months
Mean cost per joint bleed episodes by cohort for patients
Time frame: At 18 months
Number of joint bleed episodes for overall patients
Time frame: At 18 months
Number of joint bleed episodes by cohort for patients.
Time frame: At 18 months
Severity of joint bleed episodes for overall patients.
Time frame: At 18 months
Severity of joint bleed episodes by cohort for patients.
Time frame: 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 hemophilia
Time frame: 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 outcome
Time frame: At 18 months
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
Time frame: Baseline and at 18 months

Study locations

1 site

Multiple Locations, Greece

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2015 to primary completion in May 2017, 28 months.

Of 58 industry-sponsored observational studies under Hemophilia A, half reached primary completion within 55 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 75. This study's 28 months is below that.

Counting every sponsor, half of 135 studies reached it within 45 months; a quarter within 25 and three quarters within 75.

How these figures are worked out, and which studies are left out of them.

Registered: Dec 12, 2014
First posted: Dec 18, 2014
StartActual: Jan 13, 2015
Primary completionActual: May 28, 2017
CompletionActual: Feb 28, 2018
Last update: Jun 20, 2018

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Jun 20, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02319070
Lead sponsor: Bayer
Responsible party: Sponsor
First posted: Dec 18, 2014
Start date: Jan 13, 2015
Primary completion: May 28, 2017
Completion: Feb 28, 2018
Last update: Jun 20, 2018

Study contacts

Bayer Study Director

study director · Bayer

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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