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Simple DNA test could shield gout patients from deadly skin side effects

NCT ID NCT07369622

Prevention Sponsor: Haiphong University of Medicine and Pharmacy Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a genetic test can prevent rare but severe skin reactions caused by the common gout drug allopurinol. About 228 Vietnamese adults with gout will either get the test before treatment or receive standard care. Those with a high-risk gene will take a different drug (febuxostat) instead. The goal is to see if this approach is safer and cost-effective.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
allopurinol and febuxostat
What this could lead to
If successful, this approach could prevent life-threatening skin reactions in people starting gout treatment, making therapy safer for those with a specific genetic risk.
What could go wrong
This is a small, single-site study in Vietnam, so results may not apply to other populations. The genetic test is only for one risk factor, and other rare reactions could still occur.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 228 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age ≥ 18 years. Diagnosis of gout according to the 2020 ACR/EULAR classification criteria. Indicated for initiation of urate-lowering therapy (ULT) and allopurinol-naïve (no prior allopurinol exposure). Able and willing to comply with scheduled follow-up visits (baseline, Months 1, 3, 6, and 12). Provides written informed consent for participation. For the genotyping arms: provides consent for blood sampling and HLA-B\*58:01 genotyping. Exclusion Criteria: * Prior use of allopurinol or history of hypersensitivity reaction to allopurinol. Known hypersensitivity to febuxostat (for participants who would receive febuxostat). Current or recent severe skin reaction (suspected/confirmed SCAR) from any cause. End-stage kidney disease requiring dialysis or kidney transplantation. Severe hepatic impairment or active severe liver disease (e.g., AST/ALT \>3× ULN at baseline). Severe uncontrolled medical conditions that, in the investigator's judgment, could interfere with treatment or follow-up (e.g., decompensated heart failure, active malignancy requiring intensive treatment). Use of systemic immunosuppressive therapy (e.g., high-dose corticosteroids, biologics, chemotherapy) at enrollment. Pregnancy or breastfeeding. Participation in another interventional clinical study that could affect the outcomes of this study. Inability to provide informed consent or inability to adhere to study procedures.

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Conditions

The condition(s) this trial relates to.

Arthritis, Gouty gout Hyperuricemia Stevens-Johnson syndrome severe cutaneous adverse reaction prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Gout and hyperuricemia Gout arthritis Gout initiating urate-loweringurate-lowering therapy

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

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