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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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 July 28, 2014