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

This study is not yet open for participant recruitment.
Verified July 2011 by Hadassah Medical Organization
Sponsor:
ClinicalTrials.gov Identifier:
NCT01388075
First Posted: July 6, 2011
Last Update Posted: July 6, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by:
Hadassah Medical Organization
  Purpose
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 Intervention
Healthy Subjects Drug: Rifampicin

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • International Normalized Ratio (INR) [ Time Frame: 6 weeks ]

Secondary Outcome Measures:
  • Warfarin concentration [ Time Frame: 6 weeks ]

Estimated Enrollment: 150
Study Start Date: July 2011
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rifampicin
Consecutive treatments with rifampicin and placebo
Drug: Rifampicin
oral, 450 mg/day , 7 days

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy subjects

Exclusion Criteria:

  • Consumption of any medication during 30 days
  • Smoking
  • Alcohol consumption
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01388075


Contacts
Contact: Mordechai Muszkat, MD 972-6777111 ext 73793 muszkatm@hadassah.org.il

Locations
Israel
Hadassah Hebrew University Medical Center Not yet recruiting
Jerusalem, Israel, 91120
Contact: Mordechai Muszkat, MD    972-2-6777111 ext 73793    muszkatm@hadassah.org.il   
Principal Investigator: Mordechai Muszkat, MD         
Sponsors and Collaborators
Hadassah Medical Organization
  More Information

Responsible Party: Mordechai Muszkat, MD, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01388075     History of Changes
Other Study ID Numbers: HMO-0451-10
First Submitted: July 3, 2011
First Posted: July 6, 2011
Last Update Posted: July 6, 2011
Last Verified: July 2011

Keywords provided by Hadassah Medical Organization:
induction
CYP2C9
Genetic variability
Expression

Additional relevant MeSH terms:
Rifampin
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP2C8 Inducers
Cytochrome P-450 CYP2C19 Inducers
Cytochrome P-450 CYP2C9 Inducers
Cytochrome P-450 CYP3A Inducers