Glucosephosphate Dehydrogenase DeficiencyNCT00076323
A Test to Predict the Hemolytic Potential of Drugs in G6PD Deficiency
A study testing Primaquine in people with Glucosephosphate Dehydrogenase Deficiency and Favism, run by Walter Reed Army Institute of Research (WRAIR) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Glucosephosphate Dehydrogenase Deficiency, Favism
- What is being tested?
- Primaquine
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2003to Nov 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Normal clinical evaluation
- Willing and able to make all scheduled visits
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Walter Reed Army Institute of Research
Silver Spring, Maryland, 20910
About this study
Official title: A New Test to Predict the Hemolytic Potential of Drugs in G6PD Deficiency
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.
- Conditions
- Glucosephosphate Dehydrogenase Deficiency, Favism
- Being tested
- Primaquine
- Keywords
- G6PD, Favism, G6PD Deficiency, hemolysis, drug reaction, drug-induced hemolysis
- Medical subject headings
- Glucosephosphate Dehydrogenase Deficiency, Favism, Hemolysis, Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrimaquineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in degree of hemolysis of G6PD(-) red blood cells in treated vs untreated matched samples.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2004 (estimated)
- Study startDec 2003
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glucosephosphate Dehydrogenase DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants
Sponsor and investigators
- Lead sponsor
- Walter Reed Army Institute of Research (WRAIR)
- Sponsor type
- US federal agency
- Investigators
- Shon A Remich, Principal investigator, WRAIR, Experimental Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00076323
- Sponsor's protocol ID
- WRAIR 992
- Other IDs
- G6PD
- Status last verified
- Jul 2010
- First submitted
- 20 Jan 2004
- Last updated
- 27 Jul 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Test to Predict the Hemolytic Potential of Drugs in G6PD Deficiency
- ClinicalTrials.gov ID
- NCT00076323
- Acronym / sponsor ID
- WRAIR 992
- Conditions
- Glucosephosphate Dehydrogenase Deficiency, Favism
- Keywords
- G6PD, Favism, G6PD Deficiency, hemolysis, drug reaction, drug-induced hemolysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants
- Lead sponsor
- Walter Reed Army Institute of Research (WRAIR)US federal agency
- Study start
- Dec 2003
- Study completion
- Nov 2006 (actual)
- First posted
- 21 Jan 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Normal clinical evaluation
- Willing and able to make all scheduled visits
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Primaquine | Drug | – |
Primary outcome
Difference in degree of hemolysis of G6PD(-) red blood cells in treated vs untreated matched samples.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shon A Remich principal investigator
WRAIR, Experimental Therapeutics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Primaquine in people with Glucosephosphate Dehydrogenase Deficiency and Favism, run by Walter Reed Army Institute of Research (WRAIR) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in degree of hemolysis of G6PD(-) red blood cells in treated vs untreated matched samples.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2010.