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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT06253117
Phase
PHASE2
Status
Recruiting
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Conditions

  • Recurrent Acute Pancreatitis

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

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
  • Placebo — DRUG
    Placebo

Study Details

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

Key Dates

Start date
Jun 27, 2024
Status verified
Oct 2025
Primary completion
Sep 1, 2028
Completion
Sep 1, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Adverse Event [ Time Frame: 6 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
UABBirminghamAlabama35294
kondal kyanam, MD
[email protected]
(205) 975-3593
Mayo ClinicRochesterMinnesota55905
Santhi S Vege
[email protected]
1-507-284-2511

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