HemophiliaNCT01029808
Bleeding Symptoms of Carriers of Hemophilia A and B
An observational study of Hemophilia, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial summary
To collect and analyze data on female carriers of severe and moderate hemophilia A and B. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hemophilia
- How many people
- 126 participants
- Where
- 1 siteSweden
- Study dates
- Dec 2009to Jul 2011
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Carriers of severe and moderate hemophilia A and B
Who may be able to join
- Female carriers of hemophilia A and B.
Who cannot join
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
To collect and analyze data on female carriers of severe and moderate hemophilia A and B.
- Conditions
- Hemophilia
- Keywords
- carriers of hemophilia
- Medical subject headings
- Hemophilia A
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding tendency in carriers of severe and moderate haemophilia compared to a control group.
Measured: Five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HemophiliaStudies of the same condition, open and under way.
- More trials run by Sahlgrenska University HospitalThe 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
- Cross-sectional
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Olsson, Sahlgrenska University Hospital
- Investigators
- Fariba Baghaei, MD PhD, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01029808
- Sponsor's protocol ID
- VGAO002
- Status last verified
- Oct 2016
- First submitted
- 9 Dec 2009
- Last updated
- 19 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Olsson A, Hellgren M, Berntorp E, Ljung R, Baghaei F. Clotting factor level is not a good predictor of bleeding in carriers of haemophilia A and B. Blood Coagul Fibrinolysis. 2014 Jul;25(5):471-5. doi: 10.1097/MBC.0000000000000083.
PubMed 24509327Olsson A, Hellgren M, Berntorp E, Baghaei F. Association between bleeding tendency and health-related quality of life in carriers of moderate and severe haemophilia. Haemophilia. 2015 Nov;21(6):742-6. doi: 10.1111/hae.12796. Epub 2015 Sep 8.
PubMed 26346645
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bleeding Symptoms of Carriers of Hemophilia A and B
- ClinicalTrials.gov ID
- NCT01029808
- Acronym / sponsor ID
- VGAO002
- Conditions
- Hemophilia
- Keywords
- carriers of hemophilia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 10 Dec 2009 (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.
To collect and analyze data on female carriers of severe and moderate hemophilia A and B.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Carriers of severe and moderate hemophilia A and B
Key inclusion criteria (1 listed)
- Female carriers of hemophilia A and B.
Key exclusion criteria (1 listed)
- Pregnancy.
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
Bleeding tendency in carriers of severe and moderate haemophilia compared to a control group.
Time frame: Five years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2016.
- Results publication: PubMed 24509327Olsson A, Hellgren M, Berntorp E, Ljung R, Baghaei F. Clotting factor level is not a good predictor of bleeding in carriers of haemophilia A and B. Blood Coagul Fibrinolysis. 2014 Jul;25(5):471-5. doi: 10.1097/MBC.0000000000000083.
- Results publication: PubMed 26346645Olsson A, Hellgren M, Berntorp E, Baghaei F. Association between bleeding tendency and health-related quality of life in carriers of moderate and severe haemophilia. Haemophilia. 2015 Nov;21(6):742-6. doi: 10.1111/hae.12796. Epub 2015 Sep 8.
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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.
Fariba Baghaei, MD PhD study chair
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 Hemophilia, run by Sahlgrenska University Hospital at 1 site in Sweden.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 19 Oct 2016. 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 Sweden. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Bleeding tendency in carriers of severe and moderate haemophilia compared to a control group. (time frame: Five years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01029808, which also lists 2 linked publications.
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 19 Oct 2016.