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

This study has been completed.
Sponsor:
Information provided by:
Walter Reed Army Institute of Research (WRAIR)
ClinicalTrials.gov Identifier:
NCT00076323
First received: January 20, 2004
Last updated: July 26, 2010
Last verified: July 2010
History of Changes
  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:

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 May 21, 2013