EUCTR2008-005395-27-GB
Active, not recruiting
Phase 1
Inter-individual variability in response to warfarin in children: Analysis of environmental and pharmacogenetic factors - Variability in response to warfarin in children
ewcastle upon Tyne Hospitals NHS Foundation Trust0 sites120 target enrollmentApril 28, 2009
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ewcastle upon Tyne Hospitals NHS Foundation Trust
- Enrollment
- 120
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •The study will recruit children aged 1\-18 years who:
- •1\. Are on long\-term anticoagulation with warfarin;
- •2\. Are anticoagulated with a target International Normalised Ratio (INR) range of 2\-3;
- •3\. Have had a stable warfarin dosage requirement for at least the three previous clinic visits.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) no
- •F.1\.2\.1 Number of subjects for this age range
- •F.1\.3 Elderly (\>\=65 years) no
- •F.1\.3\.1 Number of subjects for this age range
Exclusion Criteria
- •Any child who fits the inclusion criteria but who is affected by inter\-current illness or is temporarily taking a medication that is known to affect sensitivity to warfarin, eg. an antibiotic. These children will be deferred and recruited at a later date following recovery from the illness and completion of antibiotic therapy.
Outcomes
Primary Outcomes
Not specified
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