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

This study has been completed.

First Received on January 20, 2004. Last Updated on July 26, 2010 History of Changes

Sponsor:	Walter Reed Army Institute of Research (WRAIR)
Information provided by:	Walter Reed Army Institute of Research (WRAIR)
ClinicalTrials.gov Identifier:	NCT00076323

Purpose

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.

Condition	Intervention
Glucosephosphate Dehydrogenase Deficiency Favism	Drug: Primaquine

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	A New Test to Predict the Hemolytic Potential of Drugs in G6PD Deficiency

Resource links provided by NLM:

Genetics Home Reference related topics: glucose-6-phosphate dehydrogenase deficiency

Drug Information available for: Primaquine phosphate Primaquine

U.S. FDA Resources

Further study details as provided by Walter Reed Army Institute of Research (WRAIR):

Primary Outcome Measures:

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

Estimated Enrollment:	14
Study Start Date:	December 2003
Study Completion Date:	November 2006

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00076323

Locations

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

Sponsors and Collaborators

Walter Reed Army Institute of Research (WRAIR)

Investigators

Principal Investigator:

Shon A Remich

WRAIR, Experimental Therapeutics

More Information

Additional Information:

Recruitment page for WRAIR Clinical Trials Center This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00076323 History of Changes
Other Study ID Numbers:	WRAIR 992, G6PD
Study First Received:	January 20, 2004
Last Updated:	July 26, 2010
Health Authority:	United States: Federal Government

Keywords provided by Walter Reed Army Institute of Research (WRAIR):

G6PD
Favism
G6PD Deficiency

hemolysis
drug reaction
drug-induced hemolysis

Additional relevant MeSH terms:

Favism
Glucosephosphate Dehydrogenase Deficiency
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Genetic Diseases, Inborn
Foodborne Diseases
Poisoning
Substance-Related Disorders
Plant Poisoning

Carbohydrate Metabolism, Inborn Errors
Metabolism, Inborn Errors
Metabolic Diseases
Primaquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012