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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-85
SponsorUniversity of Alabama at Birmingham

About this trial

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

Eligibility criteria

Qualifiers

Patients 18 - 85 years of age

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Pirfenidone
  • Placebo

Treatment groups

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of Alabama at Birmingham

Lead sponsor

Congressionally Directed Medical Research Programs

Collaborator