NCT07449091 Adaptability of an Undetectable = Untransmissible Model for HBV
| NCT ID | NCT07449091 |
| Status | Recruiting |
| Phase | — |
| Sponsor | NYU Langone Health |
| Condition | Chronic Hepatitis b |
| Study Type | OBSERVATIONAL |
| Enrollment | 55 participants |
| Start Date | 2026-05-01 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 55 participants in total. It began in 2026-05-01 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Persons with chronic hepatitis B (HBV) infection and active viremia are infectious and may transmit virus to others through blood/body fluid exposure. Immune tolerant treatment naive persons with hepatitis B infection express anxiety regarding disclosure of their infection status and significant fear of transmission to their partners leading to social isolation and impact on their personal lives. This study will provide data correlating serum and body fluid viral levels in persons with chronic hepatitis B infection not on therapy and those with viral suppression on long-term anti-retroviral therapy (ART) that may support the concept of "Undetectable=Untransmissible" (U=U) in patients with chronic hepatitis B.
Eligibility Criteria
Inclusion Criteria: Infected Individuals * Individuals above 18 years and less than 65 years with chronic hepatitis B infection * Included according to undermentioned three arms: * Infected, On-treatment arm: subjects being treated with TAF/TDF for a minimum of 2 years with sustained viral suppression indicating adherence to therapy * Infected, Untreated control arm: Immune tolerant subjects; 15 with high viral load (\>10\^6) and 5 with low viral load (\<10\^6) * Uninfected Assay Validation controls: 10 subjects with history of prior infection who have convalesced i.e., have lost surface antigen, and developed surface antibody with viral eradication * Able and willing to provide informed consent Healthy Controls * Individuals above 18 years and less than 65 years who have never been infected and have been vaccinated * Able and willing to provide informed consent Exclusion Criteria: * Individuals less than 18 years or greater than 65 years of age * Prior surgery to genitourinary tract, including prior vasectomy * Prior interferon therapy * HIV co-infection * Hepatitis C virus co-infection * Hepatitis delta virus co-infection
Contact & Investigator
AnnMarie Liapakis, MD
PRINCIPAL INVESTIGATOR
NYU Langone Health
Frequently Asked Questions
Who can join the NCT07449091 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Chronic Hepatitis b. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07449091 currently recruiting?
Yes, NCT07449091 is actively recruiting participants. Contact the research team at AnnMarie.Liapakis@nyulangone.org for enrollment information.
Where is the NCT07449091 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT07449091 clinical trial?
NCT07449091 is sponsored by NYU Langone Health. The principal investigator is AnnMarie Liapakis, MD at NYU Langone Health. The trial plans to enroll 55 participants.