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NCT05350371 · ClinicalTrials.gov registry record · Phase 1
Safety and Tolerability of Pirfenidone in Acute Pancreatitis
A Phase 1 study of Pancreatitis, Acute, sponsored by University of Alabama at Birmingham.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
- 2
- Study locations
NCT05350371 is a Phase 1 study of Pancreatitis, Acute that is actively recruiting participants, run by University of Alabama at Birmingham. The registered enrollment target is 60 participants, below the 88-participant average among 4 other Pancreatitis, Acute trials with a reported enrollment target (32% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT05350371, a Phase 1 study of Pancreatitis, Acute, is actively recruiting participants, sponsored by University of Alabama at Birmingham.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
- 2
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Pirfenidone Oral Tablet
Study Locations (2)
Alabama
- UAB - Birmingham
Minnesota
- Mayo Clinic - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2023-08-01 |
| Est. Completion | 2027-02 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05350371
The ClinicalTrials.gov registry entry for NCT05350371 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 88-participant average among 4 other Pancreatitis, Acute trials with a reported enrollment target (32% lower). The listed sponsor is University of Alabama at Birmingham, which has 1,160 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Pancreatitis, Acute appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05350371 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Alabama, Minnesota.
Frequently Asked Questions
What is clinical trial NCT05350371 about?
NCT05350371 is a clinical study titled "Safety and Tolerability of Pirfenidone in Acute Pancreatitis". 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 ha...
What is the current status of trial NCT05350371?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2023-08-01. Estimated completion is 2027-02.
What conditions does trial NCT05350371 study?
This clinical trial studies the following conditions: Pancreatitis, Acute.
What interventions are being tested in trial NCT05350371?
The interventions under investigation include: Placebo (DRUG), Pirfenidone Oral Tablet (DRUG).
Who is sponsoring clinical trial NCT05350371?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05350371 being conducted?
This trial has 2 study locations across Alabama, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.