A Test to Predict the Hemolytic Potential of Drugs in G6PD Deficiency

July 26, 2010 updated by: Walter Reed Army Institute of Research (WRAIR)

A New Test to Predict the Hemolytic Potential of Drugs in G6PD Deficiency

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Silver Spring, Maryland, United States, 20910
        • Walter Reed Army Institute of Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Difference in degree of hemolysis of G6PD(-) red blood cells in treated vs untreated matched samples.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Walter Reed Army Institute of Research (WRAIR)

Investigators

  • Principal Investigator: Shon A Remich, WRAIR, Experimental Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2003

Study Completion (Actual)

November 1, 2006

Study Registration Dates

First Submitted

January 20, 2004

First Submitted That Met QC Criteria

January 20, 2004

First Posted (Estimate)

January 21, 2004

Study Record Updates

Last Update Posted (Estimate)

July 27, 2010

Last Update Submitted That Met QC Criteria

July 26, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WRAIR 992
  • G6PD

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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