Adaptability of an Undetectable = Untransmissible Model for HBV

Part of paid clinical trials in New York, New York.

Sponsor
NYU Langone Health
Study ID
NCT07449091
Status
Recruiting
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Conditions

  • Chronic Hepatitis b
  • Viremia

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Study Details

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.

Key Dates

Start date
May 1, 2026
Status verified
May 2026
Primary completion
Sep 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
55 participants (estimated)

Arms

  • Arm: Anti-Viral Therapy
    Infected individuals on anti-viral therapy.
  • Arm: No Therapy
    Infected individuals who are not receiving anti-viral therapy.
  • Arm: Convalesced
    Individuals who have cleared HBV infection.
  • Arm: Healthy Controls
    Individuals who are uninfected.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NYU Langone HealthNew YorkNew York10016-

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By research site
NYU Langone Health· New York, NY

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