Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05350371 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Safety and Tolerability of Pirfenidone in Acute Pancreatitis

StatusCompleted
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary endpoint(s) modified Final enrollment: 1 participants — 2% of the 60 planned · Results posted: Sep 23, 2026 · Trial completed · 4 more Show 7 more changesShow less
    • Final enrollment: 1 participants — 2% of the 60 planned
    • Results posted: Sep 23, 2026
    • Trial completed
    • Study completion date changed from estimate of Feb 2027 to Feb 26, 2026
    • Eligibility criteria expanded, about 41 words
    • Secondary endpoints: details revised at 1 of 5 entries
    • Publications: details revised at 2 of 2 entries
  2. Re-verified, no change to tracked fieldsv10
  3. Enrollment target: estimated 60 to confirmed 1 Trial status: Recruiting to Completed · Primary completion date changed from estimate of Feb 2026 to Feb 26, 2026 · Study completion date changed from estimate of Feb 2027 to Feb 26, 2026 · 4 morev9 Show 7 more changesShow less
    • Trial status: Recruiting to Completed
    • Primary completion date changed from estimate of Feb 2026 to Feb 26, 2026
    • Study completion date changed from estimate of Feb 2027 to Feb 26, 2026
    • Secondary endpoints revised (5)
    • Primary endpoints revised (4)
    • Site details revised at 2 of 2 sites
    • Collaborators: 1 to 2

    See this version in full on ClinicalTrials.gov ↗

  4. Site contacts updated at 1 of 2 sitesv8
  5. Primary completion date: Mar 2026 to Feb 2026 Completion date: Jul 2026 to Feb 2027 · Site details revised at 2 of 2 sitesv7 Show 2 more changesShow less
    • Completion date: Jul 2026 to Feb 2027
    • Site details revised at 2 of 2 sites
Show 5 earlier versionsHide 5 earlier versions
  1. Primary completion date: Mar 2025 to Mar 2026 Completion date: Jul 2025 to Jul 2026v6 Show 1 more changeShow less
    • Completion date: Jul 2025 to Jul 2026
  2. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Aug 2023 to Aug 1, 2023v5 Show 1 more changeShow less
    • Start date changed from estimate of Aug 2023 to Aug 1, 2023
  3. Start date: Jun 2023 to Aug 2023v4
  4. Start date: Mar 2023 to Jun 2023v3
  5. Primary completion date: Aug 2024 to Mar 2025 Start date: Sep 2022 to Mar 2023 · Completion date: Jan 2025 to Jul 2025v2 Show 2 more changesShow less
    • Start date: Sep 2022 to Mar 2023
    • Completion date: Jan 2025 to Jul 2025
  1. 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 the current pilot clinical trial is to evaluate the safety and tolerability of pirfenidone in patients with predicted moderately severe and severe acute pancreatitis. Pirfenidone is currently approved by FDA for the treatment of idiopathic pulmonary fibrosis. Now, over 5 years of data has accumulated demonstrating safety of its use in humans. The investigators' preclinical data suggest that pirfenidone is very effective in reducing the severity of acute pancreatitis in animal models. Following are the objectives of the proposed clinical trial: Primary Objective: * To evaluate the safety and tolerability of pirfenidone, compared to placebo, in patients predicted to have moderately severe or severe AP. * To evaluate the efficacy of pirfenidone in reducing the laboratory markers of inflammation and improving patient reported outcome measures. Secondary Objective: \- To evaluate the efficacy of pirfenidone in reducing the severity of acute pancreatitis, as measured by well-defined endpoints.
Trial Details
NCT Number NCT05350371
Lead Sponsor University of Alabama at Birmingham
Collaborators: Mayo Clinic, United States Department of Defense
Conditions Pancreatitis, Acute
Enrollment 1 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov