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

Sponsors

Lead Sponsor: Hadassah Medical Organization

Source 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.

Overall Status Unknown status
Start Date July 2011
Primary Completion Date June 2018
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
International Normalized Ratio (INR) 6 weeks
Secondary Outcome
Measure Time Frame
Warfarin concentration 6 weeks
Enrollment 150
Condition
Intervention

Intervention Type: Drug

Intervention Name: Rifampicin

Description: oral, 450 mg/day , 7 days

Arm Group Label: Rifampicin

Eligibility

Criteria:

Inclusion Criteria:

- Healthy subjects

Exclusion Criteria:

- Consumption of any medication during 30 days

- Smoking

- Alcohol consumption

Gender: All

Minimum Age: 18 Years

Maximum Age: 45 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Contact

Last Name: Mordechai Muszkat, MD

Phone: 972-6777111

Phone Ext.: 73793

Email: [email protected]

Location
Facility: Contact: Investigator: Hadassah Hebrew University Medical Center Mordechai Muszkat, MD 972-2-6777111 73793 [email protected] Mordechai Muszkat, MD Principal Investigator
Location Countries

Israel

Verification Date

July 2011

Responsible Party

Name Title: Mordechai Muszkat, MD

Organization: Hadassah Medical Organization

Keywords
Has Expanded Access No
Number Of Arms 1
Arm Group

Label: Rifampicin

Type: Experimental

Description: Consecutive treatments with rifampicin and placebo

Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Basic Science

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov