Key Aspects of Medical Practice in Patients With Haemophilia A (KAPPA)

December 19, 2018 updated by: Lund University
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients from haemophilia centers.

Description

Inclusion Criteria: or forms.

  • severe haemophilia A (factor VIII<1%)
  • moderate (factor VIII<5%)
  • signed informed consent

Exclusion Criteria:

  • Not fullfilling inclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Replacement therapy
Hemophilia A receiving replacement therapy (prophylaxis or on demand)
Biological: Factor VIII replacement
Patients receive their usual treatment
Other Names:
  • factor VIII

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Outcome of factor replacement treatment
Time Frame: 3 years
Joint disase according to HJHS. Quality of Life. Health economic evalaution.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lund University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

May 19, 2014

First Submitted That Met QC Criteria

December 14, 2016

First Posted (Estimate)

December 19, 2016

Study Record Updates

Last Update Posted (Actual)

December 21, 2018

Last Update Submitted That Met QC Criteria

December 19, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012/118

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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