Genetic Variability in the Response to Warfarin at Baseline and During Induction of CYP2C9

Not Applicable

• Conditions: Healthy Subjects
• Interventions: Drug: Rifampicin

• Registration Number: NCT01388075
• Lead Sponsor: Hadassah Medical Organization

Brief Summary

The genetic factors associated with variability in CYP2C9 induction have not been elucidated. The hypothesis underlying this study is that following 7 days treatment with rifampicin, a known CYP450 inducer, the genetic variability in regulatory elements controlling CYP2C9 expression will be associated with the magnitude of change in INR response to warfarin and in CYP2C9-mediated warfarin metabolism.

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-07
• Study Start: 2011-07
• Study First Submitted: 2011-07-03
• Study First Submitted QC: 2011-07-05
• Last Update Submitted: 2011-07-05
• Study First Posted: 2011-07-06
• Last Update Posted: 2011-07-06
• Primary Completion: 2018-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Healthy subjects

Exclusion Criteria

• Consumption of any medication during 30 days
• Smoking
• Alcohol consumption

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Rifampicin	Rifampicin	Consecutive treatments with rifampicin and placebo

Primary Outcome Measures

Name	Time	Method
International Normalized Ratio (INR)	6 weeks

Secondary Outcome Measures

Name	Time	Method
Warfarin concentration	6 weeks

Trial Locations

Locations (1)

Hadassah Hebrew University Medical Center; 🇮🇱 Jerusalem, Israel