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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• 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

• 2nd 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

Locations
United States
Alabama
UAB
RECRUITING
Birmingham
Minnesota
Mayo Clinic
RECRUITING
Rochester
Contact Information
Primary
kondal Kyanam, M.B.B.S.
kbaig@uabmc.edu
(205) 975-3593
Backup
Santhi Swaroop Vege, M.D.
Time Frame
Start Date: 2024-06-27
Estimated Completion Date: 2028-09-01
Participants
Target number of participants: 60
Treatments
Placebo_comparator: Placebo
Placebo
Experimental: Pirfenidone
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
Sponsors
Collaborators: Congressionally Directed Medical Research Programs
Leads: University of Alabama at Birmingham

This content was sourced from clinicaltrials.gov

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