Inter-individual variability in response to warfarin in children: Analysis of environmental and pharmacogenetic factors - Variability in response to warfarin in children

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-005395-27-GB

Enrollment

120

Registered

2009-04-28

Start date

2009-01-27

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The study population will consist of children (0-18 years of age) who are anticoagulated with warfarin. MedDRA version: 9.1 Level: LLT Classification code 10051445 Term: Foetal warfarin syndrome

Interventions

Product Name: Warfarin Pharmaceutical Form: Tablet

Eligibility

Sex/Gender

All

Inclusion 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

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: The principle research objective is to determine the reasons why there is a variation in dose requirements in children receiving warfarin therapy. We are looking at two important potential factors: environmental; and, pharmacogenetic factors. The major environmental factor of interest is the vitamin K status of the child, ie. the amount of vitamin K that the child receives in his/her diet. We are also examining the effect of pharmacogenetic factors, ie. the role of genetic differences in genes that are important in the action and metabolism of warfarin.;Secondary Objective: Not applicable.;Primary end point(s): There are no primary end points in clinical terms. The scientific objective is to evaluate the effect of pharmacogenetic and environmental factors on inter-individual variability in response to warfarin.	—

Measure

Time frame

Main Objective: The principle research objective is to determine the reasons why there is a variation in dose requirements in children receiving warfarin therapy. We are looking at two important potential factors: environmental; and, pharmacogenetic factors. The major environmental factor of interest is the vitamin K status of the child, ie. the amount of vitamin K that the child receives in his/her diet. We are also examining the effect of pharmacogenetic factors, ie. the role of genetic differences in genes that are important in the action and metabolism of warfarin.;Secondary Objective: Not applicable.;Primary end point(s): There are no primary end points in clinical terms. The scientific objective is to evaluate the effect of pharmacogenetic and environmental factors on inter-individual variability in response to warfarin.

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026