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Evaluation of the Novel Therapeutic Hepatitis B Virus Synthetic Long Peptide Vaccination ISA104

Study acronym: HEB-PEP
StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Secondary endpoints: details revised at 1 of 2 entries Eligibility criteria expanded, about 4 words Show 1 more changeShow less
    • Eligibility criteria expanded, about 4 words
  2. Primary completion date: Sep 1, 2024 to Dec 1, 2026 Trial status: Recruiting to Active, Not Recruiting · Completion date: Nov 1, 2025 to Mar 1, 2027 · Site details revisedv4 Show 3 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Completion date: Nov 1, 2025 to Mar 1, 2027
    • Site details revised
  3. Re-verified, no change to tracked fieldsv3
  4. Trial status: Not Yet Recruiting to Recruiting Start date: May 1, 2023 to Aug 4, 2023 · Site details revisedv2 Show 2 more changesShow less
    • Start date: May 1, 2023 to Aug 4, 2023
    • Site details revised
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The goal of this clinical trial is to test ISA104 in patients with chronic hepatitis B. The main question\[s\] it aims to answer are: * How safe is ISA104? * Does ISA104 induce immunity against hepatitis B virus? Different doses of the vaccine ISA104 will be administered to participants. These participants are chronic HBV patients being actively treated with antiviral drugs. Researchers will compare the ISA104 vaccine to a placebo.
Trial Details
NCT Number NCT05841095
Lead Sponsor Erasmus Medical Center
Collaborators: ISA Pharmaceuticals B.V.
Conditions Chronic Hepatitis b
Enrollment 24 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov