Joint DiseaseKAPPANCT02996942
Key Aspects of Medical Practice in Patients With Haemophilia A
An observational study of Joint Disease, run by Lund University.
Trial summary
The KAPPa project has the aim to create an international database in which information about clinical features, therapeutic management, burden of illness and costs of severe and moderate haemophilia A patients from different countries and sites is collected. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Joint Disease
- What is being tested?
- Factor VIII replacement
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2012to Dec 2017
- How long will I take part?
- 3 Years
- 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: Patients from haemophilia centers.
Who may be able to join
- severe haemophilia A (factor VIII<1%)
- moderate (factor VIII<5%)
- signed informed consent
Who cannot join
- Not fullfilling inclusion criteria
About this study
The KAPPa project has the aim to create an international database in which information about clinical features, therapeutic management, burden of illness and costs of severe and moderate haemophilia A patients from different countries and sites is collected. The aim of this project is to analyse the influence of such different characteristics on medical, psychosocial and economic outcomes in patients over the long-term.
Read the detailed description
1000 patients with hemophilia A will be enrolled using a webbased registry. Key quality factors that will be registered are : hemophilia joint Health score (HJHS), annual bleed rate, quality of Life (EQ5D), as well as dosing of replacement therapy.
- Conditions
- Joint Disease
- Being tested
- Factor VIII replacement
- Keywords
- haemophilia, joint disease, quality of life
- Medical subject headings
- Joint Diseases, Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Factor VIII replacementBiological
Also called factor VIII
Patients receive their usual treatment
| Study group | Role | What they receive |
|---|---|---|
| Replacement therapy | Hemophilia A receiving replacement therapy (prophylaxis or on demand) Receives: Biological: Factor VIII replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Outcome of factor replacement treatment
Joint disase according to HJHS. Quality of Life. Health economic evalaution.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2016 (estimated)
- Study startJul 2012
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Why it stopped: Not active
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Joint DiseaseStudies of the same condition, open and under way.
- More trials run by Lund 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
- 0 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02996942
- Sponsor's protocol ID
- 2012/118
- Acronym
- KAPPA
- Status last verified
- Dec 2018
- First submitted
- 19 May 2014
- Last updated
- 21 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Key Aspects of Medical Practice in Patients With Haemophilia A
- ClinicalTrials.gov ID
- NCT02996942
- Acronym / sponsor ID
- KAPPA / 2012/118
- Conditions
- Joint Disease
- Keywords
- haemophilia, joint disease, quality of life
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Not active
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 19 Dec 2016 (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 KAPPa project has the aim to create an international database in which information about clinical features, therapeutic management, burden of illness and costs of severe and moderate haemophilia A patients from different countries and sites is collected. The aim of this project is to analyse the influence of such different characteristics on medical, psychosocial and economic outcomes in patients over the long-term.
Detailed description
1000 patients with hemophilia A will be enrolled using a webbased registry. Key quality factors that will be registered are : hemophilia joint Health score (HJHS), annual bleed rate, quality of Life (EQ5D), as well as dosing of replacement therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Replacement therapy | – | Biological: Factor VIII replacementHemophilia A receiving replacement therapy (prophylaxis or on demand) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients from haemophilia centers.
Key inclusion criteria (3 listed)
- severe haemophilia A (factor VIII<1%)
- moderate (factor VIII<5%)
- signed informed consent
Key exclusion criteria (1 listed)
- Not fullfilling inclusion 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 |
|---|---|---|
| Factor VIII replacementAlso: factor VIIIPatients receive their usual treatment | Biological | Replacement therapy |
Primary outcome
Outcome of factor replacement treatment
Time frame: 3 years
Joint disase according to HJHS. Quality of Life. Health economic evalaution.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2018.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Joint Disease, run by Lund University.
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: withdrawn, as of the sponsor's last update on 21 Dec 2018. 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 was withdrawn before enrolling participants, so there are no results.
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?
Outcome of factor replacement treatment (time frame: 3 years). 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 21 Dec 2018.