NCT00798499

Brief Summary

The purpose of this study is to collect reference data in patients with haemophilia. The study will also collect and store blood samples for potential future exploratory research in the disease area.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2008

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

November 12, 2008

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 26, 2008

Completed
5 days until next milestone

Study Start

First participant enrolled

December 1, 2008

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

July 2, 2009

Status Verified

July 1, 2009

First QC Date

November 12, 2008

Last Update Submit

July 1, 2009

Conditions

Hemophilia

Keywords

haemophiliapatients with haemophilia

Outcome Measures

Primary Outcomes (1)

  • Laboratory variables related to coagulation, SAEs in connection to blood sampling procedures will be collected, non-serious AEs will not be recorded

    The variables will be measured at first visit.

Study Arms (1)

1

Laboratory variables

Other: Laboratory variables

Interventions

Laboratory variablesOTHER

1 visit

1

Eligibility Criteria

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

Patients with haemophilia

You may qualify if:

  • Provision of written informed consent
  • Patients with haemophilia, all severities
  • At least 18 years old.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Research Site

Malmo, Sweden

Location

Research Site

Stockholm, Sweden

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma

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

  • Erik Berntorp, MD, PhD, Professor

    Malmo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 12, 2008

First Posted

November 26, 2008

Study Start

December 1, 2008

Study Completion

June 1, 2009

Last Updated

July 2, 2009

Record last verified: 2009-07

Locations

SE(2)