NCT01029808

Brief Summary

To collect and analyze data on female carriers of severe and moderate hemophilia A and B.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
126

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2009

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

December 1, 2009

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

December 9, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 10, 2009

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

October 19, 2016

Status Verified

October 1, 2016

Enrollment Period

1.6 years

First QC Date

December 9, 2009

Last Update Submit

October 18, 2016

Conditions

Hemophilia

Keywords

carriers of hemophilia

Outcome Measures

Primary Outcomes (1)

  • Bleeding tendency in carriers of severe and moderate haemophilia compared to a control group.

    Five years

Eligibility Criteria

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

Carriers of severe and moderate hemophilia A and B

You may qualify if:

  • Female carriers of hemophilia A and B.

You may not qualify if:

  • Pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sahlgrenska university hospital

Gothenburg, 41345, Sweden

Location

Related Publications (2)

  • Olsson A, Hellgren M, Berntorp E, Ljung R, Baghaei F. Clotting factor level is not a good predictor of bleeding in carriers of haemophilia A and B. Blood Coagul Fibrinolysis. 2014 Jul;25(5):471-5. doi: 10.1097/MBC.0000000000000083.

    PMID: 24509327RESULT

  • Olsson A, Hellgren M, Berntorp E, Baghaei F. Association between bleeding tendency and health-related quality of life in carriers of moderate and severe haemophilia. Haemophilia. 2015 Nov;21(6):742-6. doi: 10.1111/hae.12796. Epub 2015 Sep 8.

    PMID: 26346645RESULT

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

Study Officials

  • Fariba Baghaei, MD PhD

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 9, 2009

First Posted

December 10, 2009

Study Start

December 1, 2009

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

October 19, 2016

Record last verified: 2016-10

Locations

SE(1)