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Effectiveness of Antiviral Treatment in Cirrhotic Patients with Low-level Hepatitis B Virus DNA Levels

Study acronym: ATTACH
StatusActive, Not Recruiting
PhasePhase 4
Started
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Record History

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  1. Enrollment target: 200 to 600v7 Show 8 more changesShow less
    • Primary completion date: Dec 2025 to Jan 2027
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Dec 2026 to Dec 2027
    • Secondary endpoints: details revised at 1 of 1 entry
    • Primary endpoint revised
    • Study description expanded, about 237 words
    • Site details revised at 10 of 10 sites
    • Study arms: 1 to 2
  2. Enrollment target: 400 to 200v6 Show 4 more changesShow less
    • Interventions: Observation of Hepatitis B (Drug), Treatment (Drug) to Treatment (Drug)
    • Study description expanded, about 57 words
    • Study sites revised (10)
    • Study arms: 2 to 1
  3. Primary completion date: Jun 2025 to Dec 2025
    • Study completion date: Dec 2025 to Dec 2026
    v5
  4. Study sites: 9 to 10
    • Eligibility criteria revised
    v4
  5. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 9
    • Start date changed from estimate of Aug 2021 to Aug 23, 2021
    v3
  6. Re-verified, no change to tracked fieldsv2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Multicenter, Open-label, Single arm Trial with Matched Historical controls. Male and female adults with compensated liver cirrhosis due to chronic hepatitis B virus infection who have low-level viremia. To assess the efficacy of Tenofovir Alafenamide (TAF) in reducing liver-related events (hepatocellular carcinoma, liver-related events and death, decompensated liver cirrhosis) in cirrhotic chronic hepatitis B patients with low-level viremia compared with matched historical controls.
Trial Details
NCT Number NCT04780204
Lead Sponsor Asan Medical Center
Collaborators: National Evidence-Based Healthcare Collaborating Agency
Conditions
(from sponsor)		 Hepatitis B, Chronic
Related terms Hepatitis B, Chronic
Enrollment 600 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov