NCT02996942

Brief 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. 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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2012

Longer than P75 for all trials

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

May 19, 2014

Completed
2.6 years until next milestone

First Posted

Study publicly available on registry

December 19, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

December 21, 2018

Status Verified

December 1, 2018

Enrollment Period

5.4 years

First QC Date

May 19, 2014

Last Update Submit

December 19, 2018

Conditions

Joint Disease

Keywords

haemophilia, joint disease, quality of life

Outcome Measures

Primary Outcomes (1)

  • Outcome of factor replacement treatment

    Joint disase according to HJHS. Quality of Life. Health economic evalaution.

    3 years

Study Arms (1)

Replacement therapy

Hemophilia A receiving replacement therapy (prophylaxis or on demand)

Biological: Factor VIII replacement

Interventions

Factor VIII replacementBIOLOGICAL

Patients receive their usual treatment

Also known as: factor VIII
Replacement therapy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients from haemophilia centers.

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Joint DiseasesHemophilia A

Interventions

Factor VIII

Condition Hierarchy (Ancestors)

Musculoskeletal DiseasesBlood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Blood Coagulation FactorsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsProtein PrecursorsBiological Factors
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2014

First Posted

December 19, 2016

Study Start

July 1, 2012

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

December 21, 2018

Record last verified: 2018-12