NCT05413551CompletedPhase 1
Point-of-care Pharmacogenomic Testing to Optimize Isoniazid Dosing for Tuberculosis Prevention
Source: ClinicalTrials.gov · Last updated 15 Jun 2026
Brief summary (registry, in English)
This trial is designed to determine whether modifying the dose of isoniazid for individuals according to their n-acetyltransferase 2 (NAT2) genotype could increase the probability of achieving equivalence of area-under-the-curve.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 78 (actual)
- First submitted
- 7 Jun 2022
- Start date
- 23 Mar 2023
- Primary completion date
- 23 Apr 2025
- Lead sponsor
- Stanford University
- Diseases
- Tuberculosis
- NCT number
- NCT05413551
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 78
- From 23 Mar 2023 to the primary completion date, 23 Apr 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Receiving drugs that interact with Rifapentine (e.g. methadone, warfarin)
- Prior treatment for active or latent tuberculosis \> 14 days
Other illness
- Evidence of active tuberculosis or currently under evaluation for active tuberculosis
- Known intolerance or hypersensitivity to isoniazid or rifapentine
- Close contact to isoniazid- or rifampicin-resistant tuberculosis (TB) case
- Clinical diagnosis of active liver disease or alcohol dependence
Lab values
- Neutropenia (absolute neutrophil count \<1000 cells/mm3)
- alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>3 times the upper limit of normal
Who the study is looking for
- Eligible for latent tuberculosis treatment by Brazil's national guidelines\*
- provides written informed consent to participate in the study
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Federal University of Mato Grosso do Sul Coordinator of this site? Confirm its status | Campo Grande | Brazil | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.