HemophiliaNCT00798499
A Feasibility Study to Collect Data in Patients With Haemophilia
An observational study of Hemophilia, run by AstraZeneca at 2 sites in Sweden.
Trial summary
The purpose of this study is to collect reference data in patients with haemophilia. The study will also collect and store blood samples for potential future exploratory research in the disease area. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Hemophilia
- What is being tested?
- Laboratory variables
- How many people
- 50 participants
- Where
- 2 sitesSweden
- Study dates
- Dec 2008to Jun 2009
- 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: Patients with haemophilia
Who may be able to join
- Provision of written informed consent
- Patients with haemophilia, all severities
- At least 18 years old.
Who cannot join
- No exclusion criteria
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: A Multi Centre Study With no Treatment, Designed to Gain Information About the Haemophilia Patient Population
The purpose of this study is to collect reference data in patients with haemophilia. The study will also collect and store blood samples for potential future exploratory research in the disease area.
- Conditions
- Hemophilia
- Being tested
- Laboratory variables
- Keywords
- haemophilia, patients with haemophilia
- Medical subject headings
- Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laboratory variablesOther
1 visit
| Study group | Role | What they receive |
|---|---|---|
| 1 | Laboratory variables Receives: Other: Laboratory variables |
What is being measured
The primary outcome is the main question the study is designed to answer.
Laboratory variables related to coagulation, SAEs in connection to blood sampling procedures will be collected, non-serious AEs will not be recorded
Measured: The variables will be measured at first visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2008 (estimated)
- Study startDec 2008
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemophiliaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- Case only
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Erik Berntorp, MD, PhD, Professor, Principal investigator, Malmo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00798499
- Sponsor's protocol ID
- D0960M00006
- Status last verified
- Jul 2009
- First submitted
- 12 Nov 2008
- Last updated
- 2 Jul 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi Centre Study With no Treatment, Designed to Gain Information About the Haemophilia Patient Population
- ClinicalTrials.gov ID
- NCT00798499
- Acronym / sponsor ID
- D0960M00006
- Conditions
- Hemophilia
- Keywords
- haemophilia, patients with haemophilia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Study completion
- Jun 2009 (actual)
- First posted
- 26 Nov 2008 (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 purpose of this study is to collect reference data in patients with haemophilia. The study will also collect and store blood samples for potential future exploratory research in the disease area.
Study design
- Observational model
- Case only
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: Laboratory variablesLaboratory variables |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with haemophilia
Key inclusion criteria (3 listed)
- Provision of written informed consent
- Patients with haemophilia, all severities
- At least 18 years old.
Key exclusion criteria (1 listed)
- No exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laboratory variables1 visit | Other | 1 |
Primary outcome
Laboratory variables related to coagulation, SAEs in connection to blood sampling procedures will be collected, non-serious AEs will not be recorded
Time frame: The variables will be measured at first visit.
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 2 Jul 2009.
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A Study to Learn About the Study Medicine -Hympavzi in Congenital Hemophilia Patients Without Inhibitors in Japan.
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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.
Erik Berntorp, MD, PhD, Professor principal investigator
Malmo University
2 sites 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 AstraZeneca at 2 sites 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 3 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 2 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Laboratory variables related to coagulation, SAEs in connection to blood sampling procedures will be collected, non-serious AEs will not be recorded (time frame: The variables will be measured at first visit.). 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 2 Jul 2009.