Safety and Tolerability of Pirfenidone in Acute Pancreatitis

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

August 1, 2023

Primary Completion Date

February 28, 2026

Study Completion Date

February 28, 2027

Conditions
Pancreatitis, Acute
Interventions
DRUG

Pirfenidone Oral Tablet

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.

DRUG

Placebo

The placebo tablets will be an exact replica of the pirfenidone tablet.

Trial Locations (2)

35294

RECRUITING

UAB, Birmingham

55905

WITHDRAWN

Mayo Clinic, Rochester

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Mayo Clinic

OTHER

lead

University of Alabama at Birmingham

OTHER

NCT05350371 - Safety and Tolerability of Pirfenidone in Acute Pancreatitis | Biotech Hunter | Biotech Hunter