Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Recruiting Phase 1 study of Pancreatitis, Acute, sponsored by University of Alabama at Birmingham.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Development of anticipated or un-anticipated serious adverse events (class 3 or 4)
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 |
What NCT05350371 shows while recruiting
NCT05350371 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 88-participant average among 4 other Pancreatitis, Acute trials with a reported enrollment target (32% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Pancreatitis, Acute
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Pioglitazone Versus Empagliflozin for Chronic Pancreatitis/Recurrent Acute Pancreatitis Associated Diabetes Mellitus
RECRUITING · Phase 2
-
Corticosteroids to Treat Pancreatitis
RECRUITING · Phase 2
-
Smoking Cessation Trial in Recurrent Acute Pancreatitis and Chronic Pancreatitis
RECRUITING · Phase 2
-
SpHincterotomy for Acute Recurrent Pancreatitis
COMPLETED · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00576069 · 60 participants
Mechanism(s)of Airflow Limitation in Moderate-severe Persistent Asthma
- NCT01297400 · 60 participants · Phase 2
Phase 2 Pilot Study of the Safety and Efficacy of Topical MW-III in Thermal Burns
- NCT01734122 · 60 participants
Stereotactic Radiosurgery for Essential Tremor and Parkinsonian Tremor
- NCT01804634 · 60 participants · Phase 2
Reduced Intensity Haploidentical BMT for High Risk Solid Tumors
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI