Improvement of Quality of Life of Hemophiliac PatientsNCT03159663
Assessment of Quality of Life in Hemophiliac Patients
An observational study of Improvement of Quality of Life of Hemophiliac Patients, run by Assiut University at 1 site in Egypt.
Trial summary
Hemophilia is an X-linked congenital bleeding disorder caused by deficiency of coagulation factor VIII (in hemophilia A) or factor IX (in hemophilia B). The deficiency is the result of mutations of the respective clotting factor genes. Read more about this study
- Who is it for?
- Ages 10 to 70 years, men only
- Conditions the study is for
- Improvement of Quality of Life of Hemophiliac Patients
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2017to 1 Jul 2018
- 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 10 to 70 years
- Men only
- Child, Adult, Older adult
Study population: all patients
Who may be able to join
- - Hemophilia A \& B
- Different age groups (pediatric - adolescence - adult )
- Home or hospitalized treatment
- complications such as joint swelling , spontaneous bleeding, etc….
Who cannot join
- 1- Other causes of bleeding tendency such as liver failure, DIC, anticoagulant drugs, etc..
- 2- Diseases that affect joints such as osteoarthritis, SLE , etc.. 3- Mentally retarded patients.
Trial locations and contacts
1 site in 1 country.
About this study
Hemophilia is an X-linked congenital bleeding disorder caused by deficiency of coagulation factor VIII (in hemophilia A) or factor IX (in hemophilia B).
The deficiency is the result of mutations of the respective clotting factor genes.
Read the detailed description
Hemophilia is rare, with only about 1 instance in every 10,000 births (or 1 in 5,000 male births) for hemophilia A and 1 in 50,000 births for hemophilia B.
According to the World Federation of Hemophilia, 400 000 people worldwide \& 5,307 people in Egypt are suffering from hemophilia.
Hemophilia A is more common than hemophilia B, representing 80-85 % of the total hemophilia population.
Signs and symptoms of hemophilia vary according to the level of clotting factors, mild, moderate and sever.
- Unexplained excessive bleeding from cuts or injuries
- Epistaxis without a known cause
- Many large or deep bruises
- Hamoarthritis
- Hematuria and Melena.
- Intracranial hemorrhage and death
- In infants, unexplained irritability it is subjective representation of health, including not only physical,mental and social, but also emotional and everyday life dimensions in terms of well-being. Several definitions of QoL have been provided, the definition of the WHO viewing QoL as 'individuals perceptions of their position in life in the context of culture and value systems in which they live and in relation to their goals, expectation standards and concerns'
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluation and improvement of quality of life of hemophiliac patients
by questionnaire
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2017
- Study start1 Jun 2017 (estimated)
- Primary completion1 Jun 2017 (estimated)
- Study completion1 Jul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Improvement of Quality of Life of Hemophiliac PatientsStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, peter khalil, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03159663
- Sponsor's protocol ID
- Assiut1987
- Status last verified
- May 2017
- First submitted
- 17 May 2017
- Last updated
- 23 May 2017
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Quality of Life in Hemophiliac Patients
- ClinicalTrials.gov ID
- NCT03159663
- Acronym / sponsor ID
- Assiut1987
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2017 (estimated)
- Primary completion
- 1 Jun 2017 (estimated)
- Study completion
- 1 Jul 2018 (estimated)
- First posted
- 19 May 2017 (actual)
- 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.
Hemophilia is an X-linked congenital bleeding disorder caused by deficiency of coagulation factor VIII (in hemophilia A) or factor IX (in hemophilia B).
The deficiency is the result of mutations of the respective clotting factor genes.
Detailed description
Hemophilia is rare, with only about 1 instance in every 10,000 births (or 1 in 5,000 male births) for hemophilia A and 1 in 50,000 births for hemophilia B.
According to the World Federation of Hemophilia, 400 000 people worldwide \& 5,307 people in Egypt are suffering from hemophilia.
Hemophilia A is more common than hemophilia B, representing 80-85 % of the total hemophilia population.
Signs and symptoms of hemophilia vary according to the level of clotting factors, mild, moderate and sever.
- Unexplained excessive bleeding from cuts or injuries
- Epistaxis without a known cause
- Many large or deep bruises
- Hamoarthritis
- Hematuria and Melena.
- Intracranial hemorrhage and death
- In infants, unexplained irritability it is subjective representation of health, including not only physical,mental and social, but also emotional and everyday life dimensions in terms of well-being. Several definitions of QoL have been provided, the definition of the WHO viewing QoL as 'individuals perceptions of their position in life in the context of culture and value systems in which they live and in relation to their goals, expectation standards and concerns'
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 10 to 70 years
- Sex
- Male only
- Age groups
- Child, Adult, Older adult
- Study population
- all patients
Key inclusion criteria (4 listed)
- - Hemophilia A \& B
- Different age groups (pediatric - adolescence - adult )
- Home or hospitalized treatment
- complications such as joint swelling , spontaneous bleeding, etc….
Key exclusion criteria (2 listed)
- 1- Other causes of bleeding tendency such as liver failure, DIC, anticoagulant drugs, etc..
- 2- Diseases that affect joints such as osteoarthritis, SLE , etc.. 3- Mentally retarded patients.
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
evaluation and improvement of quality of life of hemophiliac patients
Time frame: one year
by questionnaire
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2017.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Improvement of Quality of Life of Hemophiliac Patients, run by Assiut University at 1 site in Egypt.
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 2 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 23 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluation and improvement of quality of life of hemophiliac patients (time frame: one year). It is what the study was designed to measure, not a finding.
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 23 May 2017.