A Test to Predict the Hemolytic Potential of Drugs in G6P... | NCT00076323

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

NCT00076323

Sponsor

Walter Reed Army Institute of Research (WRAIR)

Status

Completed

Last Update Posted

Jul 27, 2010Estimated

Enrollment

Phase

Not Applicable

Conditions

Glucosephosphate Dehydrogenase Deficiency
Favism

Interventions

Primaquine

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
G6PD

Status Module

Record Verification Date

Jul 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2003

Primary Completion Date

Not provided

Completion Date

Nov 2006Actual

First Submitted Date

Jan 20, 2004

First Submission Date that Met QC Criteria

Jan 20, 2004

First Posted Date

Jan 21, 2004Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 26, 2010

Last Update Posted Date

Jul 27, 2010Estimated

Description Module

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Primaquine	Drug

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Shon A Remich	WRAIR, Experimental Therapeutics	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Walter Reed Army Institute of Research		Silver Spring	Maryland	20910	United States

Condition Browse Module

MeSH Terms

ID	Term
D005955	Glucosephosphate Dehydrogenase Deficiency
D005236	Favism
D006461	Hemolysis
D064420	Drug-Related Side Effects and Adverse Reactions

Ancestor Terms

ID	Term
D000745	Anemia, Hemolytic, Congenital
D000743	Anemia, Hemolytic
D000740	Anemia
D006402	Hematologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011319	Primaquine

Ancestor Terms

ID	Term
D000634	Aminoquinolines
D011804	Quinolines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

Browse Leaves

Not provided

Browse Branches

Not provided