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

• Sponsor: Hadassah Medical Organization (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01388075
• Collaborator: (none)
• Enrollment: 150
• Location: 1
• Arm: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Subjects	Drug: Rifampicin	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 150 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Basic Science
• Study Start Date: Jul 1, 2011
• Anticipated Primary Completion Date: Jun 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Rifampicin Consecutive treatments with rifampicin and placebo	Drug: Rifampicin; oral, 450 mg/day , 7 days

Outcome Measures

Primary Outcome Measures

1. International Normalized Ratio (INR) [6 weeks]

Secondary Outcome Measures

1. Warfarin concentration [6 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Healthy subjects

Exclusion Criteria:

• Consumption of any medication during 30 days

• Smoking

• Alcohol consumption

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hadassah Hebrew University Medical Center	Jerusalem		Israel	91120

Sponsors and Collaborators

• Hadassah Medical Organization

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01388075
• Other Study ID Numbers: HMO-0451-10
• First Posted: Jul 6, 2011
• Last Update Posted: Jul 6, 2011
• Last Verified: Jul 1, 2011

• Keywords provided by , ,: induction; CYP2C9; Genetic variability; Expression
• Additional relevant MeSH terms: Rifampin

Study Results

No Results Posted as of Jul 6, 2011