NCT01623960

Brief Summary

The primary aim of this study is to evaluate the overall quality of life in adult patients with severe haemophilia (an inherited bleeding disorder affecting mainly men) in Turkey and to assess the impact of certain disease and drug related factors (treatment modality, presence of viral disease, inhibitor, etc.) on the quality of life.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2012

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 20, 2012

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

June 20, 2012

Status Verified

June 1, 2012

Enrollment Period

1 year

First QC Date

June 17, 2012

Last Update Submit

June 17, 2012

Conditions

Keywords

severe haemophiliaquality of life

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult male patient with severe haemophilia followed at 10 different haemophilia centers in Turkey

You may qualify if:

  • age equal or greater than 18 years
  • male gender
  • factor VIII or IX level equal or below 1%
  • patients that are willing to participate and have given a written consent

You may not qualify if:

  • age less than 18 years
  • females
  • factor levels above 1%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hemophilia A

Condition Hierarchy (Ancestors)

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

Central Study Contacts

M.Cem Ar, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Member, Subcommittee of Haemophilia, Turkish Society of Haematology

Study Record Dates

First Submitted

June 17, 2012

First Posted

June 20, 2012

Study Start

October 1, 2012

Primary Completion

October 1, 2013

Study Completion

February 1, 2014

Last Updated

June 20, 2012

Record last verified: 2012-06