Inter-individual variability in response to warfarin in children: Analysis of environmental and pharmacogenetic factors - Variability in response to warfarin in childre
- Conditions
- The study population will consist of children (0-18 years of age) who are anticoagulated with warfarin.MedDRA version: 9.1Level: LLTClassification code 10051445Term: Foetal warfarin syndrome
- Registration Number
- EUCTR2008-005395-27-GB
- Lead Sponsor
- ewcastle upon Tyne Hospitals NHS Foundation Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 120
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method