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:
Hadassah Medical Organization
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01388075
First received: July 3, 2011
Last updated: July 5, 2011
Last verified: July 2011
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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: | Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Basic Science |
Resource links provided by NLM:
MedlinePlus related topics:
Blood Thinners
Drug Information available for:
Rifampin
U.S. FDA Resources
Further study details as provided by Hadassah Medical Organization:
Primary Outcome Measures:
- International Normalized Ratio (INR) [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Warfarin concentration [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
| 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| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Healthy subjects
Exclusion Criteria:
- Consumption of any medication during 30 days
- Smoking
- Alcohol consumption
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
No publications provided
| Responsible Party: | Mordechai Muszkat, MD, Hadassah Medical Organization |
| ClinicalTrials.gov Identifier: | NCT01388075 History of Changes |
| Other Study ID Numbers: | HMO-0451-10 |
| Study First Received: | July 3, 2011 |
| Last Updated: | July 5, 2011 |
| Health Authority: | Israel: Ministry of Health |
Keywords provided by Hadassah Medical Organization:
|
induction CYP2C9 Genetic variability Expression |
Additional relevant MeSH terms:
|
Rifampin Antibiotics, Antitubercular Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
Antitubercular Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Leprostatic Agents Nucleic Acid Synthesis Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013