Back to resultsA Test to Predict the Hemolytic Potential of Drugs in G6PD Deficiency
Primary Purpose
Glucosephosphate Dehydrogenase Deficiency, Favism
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Primaquine
Sponsored by
About this trial
This is an interventional prevention trial for Glucosephosphate Dehydrogenase Deficiency focused on measuring G6PD, Favism, G6PD Deficiency, hemolysis, drug reaction, drug-induced hemolysis
Eligibility Criteria
Inclusion: Normal clinical evaluation Willing and able to make all scheduled visits Exclusion: pregnant or planning pregnancy Have taken any anti-malarial medication in past month Positive blood tests for HIV and specific types of hepatitis Allergic to primaquine
Sites / Locations
- Walter Reed Army Institute of Research
Outcomes
Primary Outcome Measures
Difference in degree of hemolysis of G6PD(-) red blood cells in treated vs untreated matched samples.
Secondary Outcome Measures
Full Information
NCT ID
NCT00076323
First Posted
January 20, 2004
Last Updated
July 26, 2010
Sponsor
Walter Reed Army Institute of Research (WRAIR)
1. Study Identification
Unique Protocol Identification Number
NCT00076323
Brief Title
A Test to Predict the Hemolytic Potential of Drugs in G6PD Deficiency
Official Title
A New Test to Predict the Hemolytic Potential of Drugs in G6PD Deficiency
Study Type
Interventional
2. Study Status
Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
December 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Walter Reed Army Institute of Research (WRAIR)
4. Oversight
5. Study Description
Brief Summary
This study will evaluate a new and safe testing method for identifying medicines that can cause problems in glucose-6-phosphate dehydrogenase (G6PD) deficient individuals. We are looking for volunteers with G6PD deficiency who would be willing to donate blood samples.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glucosephosphate Dehydrogenase Deficiency, Favism
Keywords
G6PD, Favism, G6PD Deficiency, hemolysis, drug reaction, drug-induced hemolysis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
14 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Primaquine
Primary Outcome Measure Information:
Title
Difference in degree of hemolysis of G6PD(-) red blood cells in treated vs untreated matched samples.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion:
Normal clinical evaluation
Willing and able to make all scheduled visits
Exclusion:
pregnant or planning pregnancy
Have taken any anti-malarial medication in past month
Positive blood tests for HIV and specific types of hepatitis
Allergic to primaquine
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shon A Remich
Organizational Affiliation
WRAIR, Experimental Therapeutics
Official's Role
Principal Investigator
Facility Information:
Facility Name
Walter Reed Army Institute of Research
City
Silver Spring
State/Province
Maryland
ZIP/Postal Code
20910
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Test to Predict the Hemolytic Potential of Drugs in G6PD Deficiency
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