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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 3INTERVENTIONAL

TB YOUTH - TB sYstemic Management Using One-month, Ultra-short TPT Regimen for scHool Contacts

TB YOUTH - TB sYstemic Management Using One-month, Ultra-short TPT Regimen for scHool Contacts (NCT06022146) is a Phase 3 interventional studying Tuberculosis and Latent Tuberculosis, sponsored by Huashan Hospital. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

This is a prospective, multi-center, open-label, cluster randomized controlled clinical trial conducted in school settings to estimate the non-inferiority effect of 1H3P3 compared with 3HR.

What Stage of Research Is This?

Phase 3 trials confirm efficacy and safety in large patient groups (often 300–3,000+) and form the evidence base for an FDA approval submission. For Tuberculosis, Phase 3 studies typically randomize participants between the investigational treatment and either a placebo or current standard of care. A successful Phase 3 result is the threshold most treatments need to clear before regulatory approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 3,520 participants makes this one of the larger Tuberculosis trials currently registered. Trials at this scale are typically global, run across many sites, and designed to generate the definitive evidence package for an FDA approval submission or a label expansion.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Aged ≥13 years and body weight ≥ 30 kg; 2. School-registered individuals including: - Currently attending junior / senior high school or university students; - School staff members; 3. Close contacts of active pulmonary TB index cases (confirmed or clinically diagnosed) within the school, defined by meeting both of the following: - Teachers/students sharing the same classroom or dormitory with the index case; - Exposure history: Prolonged sharing of enclosed space (\>4 hours total within 1 week) with the index case; 4. Confirmed LTBI status through screening; 5. Voluntary participation with signed willing to sign a consent form form (for adults ≥18 years); 6. Parental / guardian consent and co-signed willing to sign a consent form form (for minors aged 13-17 years). Who Should NOT Join This Trial: 1. Current active TB disease (clinically or bacteriologically confirmed); 2. Documented isoniazid/rifampicin resistance in the corresponding M. tuberculosis strain from the index case; 3. Self-reported use of rifamycins (e.g., rifampicin, rifapentine) or isoniazid for \>14 consecutive days within the past 2 years; 4. Prior completion of full-course of treatment for ATB or LTBI; 5. Hypersensitivity or intolerance to rifamycins (rifapentine / rifampicin) or isoniazid; 6. HIV positive serostatus or AIDS patients; 7. History of viral hepatitis (e.g., chronic hepatitis B, chronic hepatitis C) or liver cirrhosis; 8. Liver dysfunction (TBil\>2.5mg/dL \[43umol/L\] or ALT / AST\>2ULN) or renal dysfunction. 9. Current receiving immunosuppressive therapy or biological agents. 10. Hematologic disorders with either PLT\<50×109/L or WBC\<3.0×109/L. 11. Other conditions deemed unsuitable for TPT by investigators. Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Aged ≥13 years and body weight ≥ 30 kg; 2. School-registered individuals including: * Currently attending junior / senior high school or university students; * School staff members; 3. Close contacts of active pulmonary TB index cases (confirmed or clinically diagnosed) within the school, defined by meeting both of the following: * Teachers/students sharing the same classroom or dormitory with the index case; * Exposure history: Prolonged sharing of enclosed space (\>4 hours total within 1 week) with the index case; 4. Confirmed LTBI status through screening; 5. Voluntary participation with signed informed consent form (for adults ≥18 years); 6. Parental / guardian consent and co-signed informed consent form (for minors aged 13-17 years). Exclusion Criteria: 1. Current active TB disease (clinically or bacteriologically confirmed); 2. Documented isoniazid/rifampicin resistance in the corresponding M. tuberculosis strain from the index case; 3. Self-reported use of rifamycins (e.g., rifampicin, rifapentine) or isoniazid for \>14 consecutive days within the past 2 years; 4. Prior completion of full-course of treatment for ATB or LTBI; 5. Hypersensitivity or intolerance to rifamycins (rifapentine / rifampicin) or isoniazid; 6. HIV positive serostatus or AIDS patients; 7. History of viral hepatitis (e.g., chronic hepatitis B, chronic hepatitis C) or liver cirrhosis; 8. Liver dysfunction (TBil\>2.5mg/dL \[43umol/L\] or ALT / AST\>2ULN) or renal dysfunction. 9. Current receiving immunosuppressive therapy or biological agents. 10. Hematologic disorders with either PLT\<50×109/L or WBC\<3.0×109/L. 11. Other conditions deemed unsuitable for TPT by investigators.

Treatments Being Tested

DRUG

isoniazid and rifapentine

12-dose ultra-short TPT 1H3P3 regimen of isoniazid and rifapentine 3 times a week for 4 weeks

DRUG

Rifampin and Isoniazid

3HR regimen of isoniazid and rifampicin once daily for three months

Locations (20)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

People's Hospital of Hezhang
Bijie, Guizhou, China
People's Hospital of Qianxi
Bijie, Guizhou, China
People's Hospital of Weining
Bijie, Guizhou, China
People's Hospital of Zhijin
Bijie, Guizhou, China
People's Hospital of Zhijin
Bijie, Guizhou, China
People's Hospital of Daozhen Klau and Hmong autonomous county
Daozhen Klau and Hmong Autonomous County in Zun'yi, Guizhou, China
Liuzhi Special District
Liupanshui, Guizhou, China
People's Hospital of Panzhou
Liupanshui, Guizhou, China
People's Hospital of Shuicheng District, Liupanshui City
Liupanshui, Guizhou, China
Second People's Hospital of Liupanshui City
Liupanshui, Guizhou, China
Third People's Hospital of Liupanshui
Liupanshui, Guizhou, China
People's Hospital of Cengong
Qiandongnan Miao and Dong Autonomous Prefecture, Guizhou, China
People's Hospital of Congjiang
Qiandongnan Miao and Dong Autonomous Prefecture, Guizhou, China
First People's Hospital of Kaili
Qiandongnan Miao and Dong Autonomous Region, Guizhou, China
People's Hospital of Danzhai
Qiandongnan Miao and Dong Autonomous Region, Guizhou, China
People's Hospital of Huangping
Qiandongnan Miao and Dong Autonomous Region, Guizhou, China
People's Hospital of Jianhe
Qiandongnan Miao and Dong Autonomous Region, Guizhou, China
People's Hospital of Jinping
Qiandongnan Miao and Dong Autonomous Region, Guizhou, China
People's Hospital of Liping
Qiandongnan Miao and Dong Autonomous Region, Guizhou, China
People's Hospital of Rongjiang
Qiandongnan Miao and Dong Autonomous Region, Guizhou, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06022146), the sponsor (Huashan Hospital), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06022146 clinical trial studying?

This is a prospective, multi-center, open-label, cluster randomized controlled clinical trial conducted in school settings to estimate the non-inferiority effect of 1H3P3 compared with 3HR. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06022146?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06022146?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06022146. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06022146. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.