Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT04496882 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Chronic Hepatitis b Patients Switch to tAf After Discontinuation of Nucleoside Analogue

Study acronym: CHANGE
StatusActive, Not Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date changed from estimate of Dec 31, 2022 to Jan 1, 2025 Trial status: Recruiting to Active, Not Recruiting · Study sites: 7 to 8 · Completion date: Dec 31, 2023 to Dec 31, 2026 · 2 morev3 Show 5 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 7 to 8
    • Completion date: Dec 31, 2023 to Dec 31, 2026
    • Collaborators: 6 to 7
    • Eligibility criteria shortened, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  2. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Jul 25, 2020 to Sep 9, 2020 · Site details revised at 7 of 7 sitesv2 Show 2 more changesShow less
    • Start date changed from estimate of Jul 25, 2020 to Sep 9, 2020
    • Site details revised at 7 of 7 sites
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
We will conduct a phase 4, multicenter, open-label trial at 8 academic centers in Taiwan. Chronic hepatitis B patients receiving oral antiviral therapy (entecavir \[ETV\], tenofovir disoproxil fumarate \[TDF\]) for at least 1 year, and fulfil the following nucleos(t)ide analogs discontinuation criteria. After nucleos(t)ide analogs discontinuation, patients had a clinical relapse and retreatment regimen switches to TAF. The protocol will be approved by Institutional Review Board (IRB) or Research ethic committee (REC) of each site and will be conducted in accordance with the principles of Declaration of Helsinki and the International Conference on Harmonization for Good Clinical Practice. Each patient provides written informed consent before enrollment.
Trial Details
NCT Number NCT04496882
Lead Sponsor National Taiwan University Hospital
Collaborators: National Taiwan University Hospital, Yun-Lin Branch, Taipei City Hospital, Chiayi Christian Hospital, Dalin Tzu Chi General Hospital, E-DA Hospital, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, National Taiwan University Hospital Hsin-Chu Branch
Conditions Chronic Hepatitis b, Hepatitis B Reactivation
Enrollment 260 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov