Safety and Tolerability of Pirfenidone in Acute Pancreatitis

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT05350371
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Pancreatitis, Acute

Eligibility Criteria

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

Interventions

  • Pirfenidone Oral Tablet — DRUG
    Patients in the pirfenidone treatment arm will be given pirfenidone 267mg tablet, tid for 1 day followed by dose escalation to two 267 mg tablet tid for 6 days. Thus, the treatment will be for total of 7 days or till patients develop an adverse event that requires their participation in the study to be stopped.
  • Placebo — DRUG
    The placebo tablets will be an exact replica of the pirfenidone tablet.

Study Details

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.

Key Dates

Start date
Aug 1, 2023
Status verified
Jun 2025
Primary completion
Feb 28, 2026
Completion
Feb 28, 2027

Study Design

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

Arms

  • Experimental: Placebo
  • Experimental: Pirfenidone Treatment

Primary Outcome Measure

Development of anticipated or un-anticipated serious adverse events (class 3 or 4) [ Time Frame: 6 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
UABBirminghamAlabama35294
Vikas Dudeja, MD
[email protected]
205 975 7836
Mayo ClinicRochesterMinnesota55905-

Find similar trials in Birmingham, AL

By research site
UAB· Birmingham, ALMayo Clinic· Rochester, MN

Related Studies