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Comparative Study Between Obeticholic Acid Versus Vitamin E in Patients with Non-alcoholic Steatohepatitis

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Oct 25, 2024 to Oct 25, 2026 Completion date: Dec 30, 2024 to Dec 30, 2026v4 Show 1 more changeShow less
    • Completion date: Dec 30, 2024 to Dec 30, 2026
  2. Primary endpoints: 3 to 2 Primary completion date: Jun 25, 2024 to Oct 25, 2024 · Secondary endpoints: 7 to 5v3 Show 2 more changesShow less
    • Primary completion date: Jun 25, 2024 to Oct 25, 2024
    • Secondary endpoints: 7 to 5

    See this version in full on ClinicalTrials.gov ↗

  3. Primary completion date: May 25, 2023 to Jun 25, 2024 Completion date: Sep 30, 2024 to Dec 30, 2024 · Secondary endpoints: 11 to 7v2 Show 2 more changesShow less
    • Completion date: Sep 30, 2024 to Dec 30, 2024
    • Secondary endpoints: 11 to 7

    See this version in full on ClinicalTrials.gov ↗

  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Tanta University
394 trials monitored
See 11 trials at risk
NASH / MASH
654 trials monitored
See 22 trials at risk
This study aims at evaluating and comparing the protective outcomes of using Obeticholic acid versus Vitamin E in NASH patients without cirrhosis. The intervention is 6-months duration and the study will assess the efficacy of either drug as fibrosis improvement (≥ 1 stage) with no worsening of NASH or NASH resolution with no worsening of fibrosis with the study considered successful if either 1ry end point is met. . Also, assessment of biochemical markers related to steatosis, inflammation, oxidative stress, insulin resistance and liver fibrosis will be done.
Trial Details
NCT Number NCT05573204
Lead Sponsor Tanta University
Conditions Non-alcoholic Steatohepatitis
Enrollment 59 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov