Recruiting

Hepatitis B Research

Sponsor:

NYU Langone Health

Code:

NCT07449091

Conditions

Chronic Hepatitis b

Viremia

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Study Details

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.

Conditions

Chronic Hepatitis b

Viremia

Study ID

NCT07449091

Start date

May 1, 2026

Status verified date

May, 2026

Completion date

Sep, 2027

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

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

Study Design

Enrollment

55 participants

Anticipated

Interventions and Outcome Measures

Arms

Anti-Viral Therapy

Infected individuals on anti-viral therapy.

No Therapy

Infected individuals who are not receiving anti-viral therapy.

Convalesced

Individuals who have cleared HBV infection.

Healthy Controls

Individuals who are uninfected.

Primary outcome measure

  • Percentage of Individuals with Detectable HBV DNA [ Time Frame: Up to Month 6 ]
  • HBV DNA Levels [ Time Frame: Up to Month 6 ]

Central Contacts and Locations

Central contacts

AnnMarie Liapakis, MD

212-263-3751AnnMarie.Liapakis@nyulangone.org

Locations

NYU Langone Health

Recruiting

New York, New York, United States, 10016

More Information

Sponsor

NYU Langone Health

Last update posted

May 15, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2026-05-15.