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

NCT06253117 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: IRB-300012263HT9425-23-1-0900
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Recurrent Acute Pancreatitis

Outcome Measures

Primary Outcomes (1)

• Adverse Event

  Development of anticipated or un-anticipated serious adverse events (class 3-4)

  6 months

Secondary Outcomes (15)

• Development of Recurrent AP

  2 years

• Severity of Recurrent Attacks of AP

  2 years

• ER Visits

  2 years

• QOL

  2 years

• Patient reported outcomes

  2 years

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Pirfenidone

EXPERIMENTAL

Pirfenidone Days 1-7: 267 mg PO TID (801 mg/day) Days 8-14: 534 mg PO TID (1602 mg/day) Day 15 and thereafter: 801 mg PO TID; not to exceed 2403 mg/day Total duration of experimental or placebo drug treatment 6 months

Drug: Pirfenidone

Interventions

Pirfenidone DRUG

Pirfenidone Days 1-7: 267 mg PO TID (801 mg/day) Days 8-14: 534 mg PO TID (1602 mg/day) Day 15 and thereafter: 801 mg PO TID; not to exceed 2403 mg/day Duration of treatment- total 6 months

Pirfenidone

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• Ability to understand and the willingness to sign a written informed consent document and medical release
• Willing and able to comply with trial protocol and follow up
• nd AP episode despite correction of the AP etiology (if identified) after the 1st episode as follows i. Patients with biliary pancreatitis who have undergone cholecystectomy, with or without ERCP (if indicated) ii. Patients with hypertriglyceridemia induced pancreatitis who have serum triglyceride levels below 400 while on medication management iii. Patients with medication induced AP developing a 2nd AP episode despite stopping the culprit medication

You may not qualify if:

• Age \< 18 or \> 85 years.
• Body weight \> 200 kg.
• Ongoing AP (in right clinical situation defined by pain\>3, vomiting ≥once a week, fever or chills, not tolerating light diet) or diagnosis of AP in previous 30 days.
• Diagnosis of chronic pancreatitis, one of the following
• Ductal stricture, calcification and/or atrophy, as seen on CT scan/MRI
• or more of the 9 EUS criteria used to diagnose CP
• Known hypersensitivity to Pirfenidone.
• AST/ALT \> 3 times the upper normal limit.
• Alkaline phosphatase \>2.5 times the upper normal limit.
• Bilirubin higher than upper normal limit.
• Moderate to severe heart failure and/or coronary heart disease (New York Heart Association (NYHA) Functional Class III/IV).
• On home oxygen or home mechanical ventilation.
• Advanced liver disease as defined by Child-Pugh cirrhosis B or C.
• Paralytic ileus or significant nausea and vomiting preventing administration of light diet.
• Chronic diarrhea (\>6 months, 3 or more stools/day-Clinically not appearing to be steatorrhea \[fecal fat if done less than 15 g per day and fecal elastase if done more than 100\].Active cancer (on chemotherapy, radiation or treatment of cancer at the time of enrollment) or cancer free \<3 years (non-melanoma skin cancer are not a contraindication)

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Congressionally Directed Medical Research Programs: collaborator

Study Sites (2)

UAB

Birmingham, Alabama, 35294, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

MeSH Terms

Conditions

Pancreatitis

Interventions

pirfenidone

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Central Study Contacts

kondal Kyanam, M.B.B.S.

CONTACT

(205) 975-3593; kbaig@uabmc.edu

Santhi Swaroop Vege, M.D.

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 20, 2024
• First Posted: February 12, 2024
• Study Start: June 27, 2024
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: October 14, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)