RecruitingPhase 2

Evaluation of Pirfenidone as a Novel Therapeutic Strategy Against Recurrent Acute Pancreatitis.

United States60 participantsStarted 2024-06-27

Plain-language summary

This clinical will evaluate the safety, tolerability and early efficacy of pirenidone in patients with recurrent acute pancreatitis.

Who can participate

Age range

18 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Patients 18 - 85 years of age
. Two or more documented attacks of acute pancreatitis, separated by 3 months from one another, defined by at least 2 of the following 3:
. amylase or lipase values, or both, that are greater than 3 times the upper limit of normal values
. characteristic cross-sectional imaging
. typical upper abdominal pain according to the revised Atlanta classification28
. Drug/placebo treatment to start
. Mild AP Patient is discharged out of the hospital 30 days after diagnosis of mild AP
. Moderate Severe or Severe AP Patient is discharged out of hospital Intra-abdominal collections are either resolved on imaging, or are improving and asymptomatic (VAS Pain score ≤3 \[with or without pain medication\], vomiting ≤once a week, tolerating light diet, and no fever and chills) and do not warrant any intervention (per treating physician)

Exclusion criteria

. Age \< 18 or \> 85 years.
. Body weight \> 200 kg.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Adverse Event

Timeframe: 6 months

Trial details

NCT IDNCT06253117

SponsorUniversity of Alabama at Birmingham

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-09-01

Contact for this trial

Kondal Kyanam, M.B.B.S.

(205) 975-3593 kbaig@uabmc.edu

View on ClinicalTrials.gov More Recurrent Acute Pancreatitis trials