Hemophilia ANCT00581438
Study Evaluating Approach to Treatment of Haemophilia A and B in Spain
An observational study of Hemophilia A and Hemophilia B, run by Wyeth is now a wholly owned subsidiary of Pfizer.
Trial summary
Analyze the clinical and therapeutic approach to treatment of haemophilia A and B in habitual clinical practice conditions in Spain. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hemophilia A, Hemophilia B
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- Jun 2007to Dec 2007
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: People known to have Haemophilia A or B
Who may be able to join
- Haemophilia A or B patients of any age
- Written informed consent
Who cannot join
None listed.
About this study
Official title: Actual Approach to Treatment of Haemophilia A and B in Spain
Analyze the clinical and therapeutic approach to treatment of haemophilia A and B in habitual clinical practice conditions in Spain.
Read the detailed description
Analyze the clinical and therapeutic approach to treatment of haemophilia A and B in habitual clinical practice conditions in Spain during the first 3 years since diagnosis.
Assess haemophilia A or B patient profile, study different kinds of hanitual clinical treatment of haemophilia A and B patients, and estimate the kind of treatment and dosage units used per year in patients under habitual clinical practice conditions.
- Conditions
- Hemophilia A, Hemophilia B
- Keywords
- Approach Haemophilia A and B
- Medical subject headings
- Hemophilia A, Hemophilia B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analyze the clinical and therapeutic approach to treament of haemophilia A and B in habitual clinical practice conditions in Spain during the first 3 years since diagnosis.
Measured: 3 months
Secondary outcomes (1)
Assess haemophilia A or B patient profile, study different kinds of habitual clinical treatment of haemophilia A and B patients, and estimate the dosage units used per year in patients under habitual clinical practice conditions.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2007 (estimated)
- Study startJun 2007
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemophilia AStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Monitor, Study director, Wyeth is now a wholly owned subsidiary of Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00581438
- Sponsor's protocol ID
- 3082A-102378
- Status last verified
- Dec 2007
- First submitted
- 21 Dec 2007
- Last updated
- 27 Dec 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Actual Approach to Treatment of Haemophilia A and B in Spain
- ClinicalTrials.gov ID
- NCT00581438
- Acronym / sponsor ID
- 3082A-102378
- Conditions
- Hemophilia A, Hemophilia B
- Keywords
- Approach Haemophilia A and B
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 27 Dec 2007 (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.
Analyze the clinical and therapeutic approach to treatment of haemophilia A and B in habitual clinical practice conditions in Spain.
Detailed description
Analyze the clinical and therapeutic approach to treatment of haemophilia A and B in habitual clinical practice conditions in Spain during the first 3 years since diagnosis.
Assess haemophilia A or B patient profile, study different kinds of hanitual clinical treatment of haemophilia A and B patients, and estimate the kind of treatment and dosage units used per year in patients under habitual clinical practice conditions.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- People known to have Haemophilia A or B
Key inclusion criteria (2 listed)
- Haemophilia A or B patients of any age
- Written informed consent
Key exclusion criteria (0 listed)
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
Analyze the clinical and therapeutic approach to treament of haemophilia A and B in habitual clinical practice conditions in Spain during the first 3 years since diagnosis.
Time frame: 3 months
1 secondary outcome
Assess haemophilia A or B patient profile, study different kinds of habitual clinical treatment of haemophilia A and B patients, and estimate the dosage units used per year in patients under habitual clinical practice conditions.
Time frame: 3 months
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 27 Dec 2007.
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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.
Medical Monitor study director
Wyeth is now a wholly owned subsidiary of Pfizer
Questions about this trial
What is this clinical trial studying?
An observational study of Hemophilia A and Hemophilia B, run by Wyeth is now a wholly owned subsidiary of Pfizer.
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 2 inclusion and 0 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 27 Dec 2007. 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?
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?
Analyze the clinical and therapeutic approach to treament of haemophilia A and B in habitual clinical practice conditions in Spain during the first 3 years since diagnosis. (time frame: 3 months). 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 27 Dec 2007.