HaemophiliaTurkHaemQoLNCT01623960
Quality of Life in Adult Patients With Severe Haemophilia in Turkey
An observational study of Haemophilia, run by Turkish Society of Hematology.
Trial summary
The primary aim of this study is to evaluate the overall quality of life in adult patients with severe haemophilia (an inherited bleeding disorder affecting mainly men) in Turkey and to assess the impact of certain disease and drug related factors (treatment modality, presence of viral disease, inhibitor, etc.) on the… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Haemophilia
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Oct 2012to Feb 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Adult male patient with severe haemophilia followed at 10 different haemophilia centers in Turkey
Who may be able to join
- age equal or greater than 18 years
- male gender
- factor VIII or IX level equal or below 1%
- patients that are willing to participate and have given a written consent
Who cannot join
- age less than 18 years
- females
- factor levels above 1%
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Nationwide Multicenter Study on the Quality of Life in Adult Patients With Severe Haemophilia in Turkey
The primary aim of this study is to evaluate the overall quality of life in adult patients with severe haemophilia (an inherited bleeding disorder affecting mainly men) in Turkey and to assess the impact of certain disease and drug related factors (treatment modality, presence of viral disease, inhibitor, etc.) on the quality of life.
Read the detailed description
Haemophilia is an inherited bleeding disorder affecting one in 10000 male births worldwide. People with severe haemophilia usually suffer from recurrent life threatening bleeds (e.g. into the brain, digestive system or abdomen) and/or disabling degenerative disease of weight bearing joints (e.g. knees, elbows and ankles)resulting from haemorrhage into the joints. Daily activities of people with haemophilia has been shown to be dramatically hampered by the resultant joint damage. Evaluation of quality of life issues in people with severe haemophilia would help to create awareness of their problems and limitations. This would also set up the scene for developing policies to improve the treatment options/facilities and social life of the patients. Current study aims to assess the quality of life of adult patients with severe haemophilia in a developing country (Turkey) by using a validated Quality of Life Questionnaire (Turkish version of Haem-A-QoL).
- Conditions
- Haemophilia
- Keywords
- severe haemophilia, quality of life
- Medical subject headings
- Hemophilia A
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2012 (estimated)
- Study startOct 2012
- Primary completionOct 2013 (estimated)
- Study completionFeb 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HaemophiliaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Turkish Society of Hematology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, M. Cem Ar, Turkish Society of Hematology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01623960
- Sponsor's protocol ID
- THD-HAEM-QoL
- Acronym
- TurkHaemQoL
- Status last verified
- Jun 2012
- First submitted
- 17 Jun 2012
- Last updated
- 20 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Nationwide Multicenter Study on the Quality of Life in Adult Patients With Severe Haemophilia in Turkey
- ClinicalTrials.gov ID
- NCT01623960
- Acronym / sponsor ID
- TurkHaemQoL / THD-HAEM-QoL
- Conditions
- Haemophilia
- Keywords
- severe haemophilia, quality of life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Turkish Society of HematologyUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Oct 2013 (estimated)
- Study completion
- Feb 2014 (estimated)
- First posted
- 20 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary aim of this study is to evaluate the overall quality of life in adult patients with severe haemophilia (an inherited bleeding disorder affecting mainly men) in Turkey and to assess the impact of certain disease and drug related factors (treatment modality, presence of viral disease, inhibitor, etc.) on the quality of life.
Detailed description
Haemophilia is an inherited bleeding disorder affecting one in 10000 male births worldwide. People with severe haemophilia usually suffer from recurrent life threatening bleeds (e.g. into the brain, digestive system or abdomen) and/or disabling degenerative disease of weight bearing joints (e.g. knees, elbows and ankles)resulting from haemorrhage into the joints. Daily activities of people with haemophilia has been shown to be dramatically hampered by the resultant joint damage. Evaluation of quality of life issues in people with severe haemophilia would help to create awareness of their problems and limitations. This would also set up the scene for developing policies to improve the treatment options/facilities and social life of the patients. Current study aims to assess the quality of life of adult patients with severe haemophilia in a developing country (Turkey) by using a validated Quality of Life Questionnaire (Turkish version of Haem-A-QoL).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult male patient with severe haemophilia followed at 10 different haemophilia centers in Turkey
Key inclusion criteria (4 listed)
- age equal or greater than 18 years
- male gender
- factor VIII or IX level equal or below 1%
- patients that are willing to participate and have given a written consent
Key exclusion criteria (3 listed)
- age less than 18 years
- females
- factor levels above 1%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Haemophilia, run by Turkish Society of Hematology.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact M.Cem Ar, MD, PhD (+905326818890, mcemar68@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2012.