NCT07449091Recruiting
Adaptability of an Undetectable = Untransmissible Model for HBV
Adaptability of an Undetectable = Untransmissible Model for HBV: Are Suppressed Viral Levels in the Serum Consistent Across Body Fluid Reservoirs?
Source: ClinicalTrials.gov · Last updated 15 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 55 (estimated)
- First submitted
- 27 Feb 2026
- Start date
- 1 May 2026
- Primary completion date
- Sept 2027
- Lead sponsor
- NYU Langone Health
- Diseases
- Hepatitis B
- NCT number
- NCT07449091
What you commit to
- Study type: Observational
- Planned participants: 55
- From 1 May 2026 to the primary completion date, Sept 2027
- 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
- Prior surgery to genitourinary tract, including prior vasectomy
- Prior interferon therapy
Other illness
- HIV co-infection
- Hepatitis C virus co-infection
- Hepatitis delta virus co-infection
Age
- Individuals less than 18 years or greater than 65 years of age
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Accepts 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 |
|---|---|---|---|
| NYU Langone Health Coordinator of this site? Confirm its status | New York | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.