NCT00076323

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2003

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2003

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 20, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 21, 2004

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
Last Updated

July 27, 2010

Status Verified

July 1, 2010

First QC Date

January 20, 2004

Last Update Submit

July 26, 2010

Conditions

Glucosephosphate Dehydrogenase DeficiencyFavism

Keywords

G6PDFavismG6PD Deficiencyhemolysisdrug reactiondrug-induced hemolysis

Outcome Measures

Primary Outcomes (1)

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

Interventions

PrimaquineDRUG

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Normal clinical evaluation
  • Willing and able to make all scheduled visits

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Walter Reed Army Institute of Research

Silver Spring, Maryland, 20910, United States

Location

MeSH Terms

Conditions

Glucosephosphate Dehydrogenase DeficiencyFavismHemolysisDrug-Related Side Effects and Adverse Reactions

Interventions

Primaquine

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCarbohydrate Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsMetabolic DiseasesNutritional and Metabolic DiseasesFoodborne DiseasesPoisoningChemically-Induced DisordersPlant PoisoningPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AminoquinolinesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Shon A Remich

    WRAIR, Experimental Therapeutics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
FED

Study Record Dates

First Submitted

January 20, 2004

First Posted

January 21, 2004

Study Start

December 1, 2003

Study Completion

November 1, 2006

Last Updated

July 27, 2010

Record last verified: 2010-07

Locations

US(1)