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

NCT ID: NCT01388075

Last Updated: 2011-07-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Subjects

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Rifampicin

Consecutive treatments with rifampicin and placebo

Group Type EXPERIMENTAL

Rifampicin

Intervention Type DRUG

oral, 450 mg/day , 7 days

Interventions

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Rifampicin

oral, 450 mg/day , 7 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy subjects

Exclusion Criteria

* Consumption of any medication during 30 days
* Smoking
* Alcohol consumption
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hadassah Medical Organization

OTHER

Sponsor Role lead

Responsible Party

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Hadassah Medical Organization

Locations

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Hadassah Hebrew University Medical Center

Jerusalem, , Israel

Site Status

Countries

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Israel

Central Contacts

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Mordechai Muszkat, MD

Role: CONTACT

[email protected]
972-6777111 ext. 73793

Facility Contacts

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Mordechai Muszkat, MD

Role: primary

[email protected]
972-2-6777111 ext. 73793

Other Identifiers

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HMO-0451-10

Identifier Type: -

Identifier Source: org_study_id

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