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

Tracking Information

First Received Date ^ICMJE

January 20, 2004

Last Updated Date

January 31, 2006

Start Date ^ICMJE

December 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00076323 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacodynamics Study

Condition ^ICMJE

Glucosephosphate Dehydrogenase Deficiency
Favism

Intervention ^ICMJE

Drug: Primaquine

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Suspended

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00076323

Responsible Party

Study ID Numbers ^ICMJE

WRAIR 992, G6PD

Study Sponsor ^ICMJE

Walter Reed Army Institute of Research (WRAIR)

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Shon A Remich

WRAIR, Experimental Therapeutics

Information Provided By

Walter Reed Army Institute of Research (WRAIR)

Verification Date

January 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP