Pirfenidone as Treatment of Chronic Pancreatitis
ConditionChronic Pancreatitis
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-85
SponsorVikas Dudeja
About this trial
The proposed project is focused towards evaluation of Pirfenidone as a novel therapeutic strategy in patients with chronic pancreatitis (CP).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients 18 - 85 years of age
Pancreatic parenchymal and/or ductal calcification
Unequivocal CP on imaging (Tirkes et al3) (Cambridge grade 3 or grade 4)
Average pain of >/=4 (on a 0-10 scale) related to pancreatitis in the past three months [regardless of the use of pain medications (opioids or non-opioids)] and/or evidence of ongoing pancreatic inflammatory activity, with an inflammatory pancreatic flare occurring one or more times within the past six months [inflammatory pancreatic flare is defined as an exacerbation of pancreatic pain in combination with one or more of the following: 1) plasma amylase/lipase levels elevated 2-folds or more than the upper limit of normal; 2) elevated plasma levels of CRP 2-fold or more than the upper normal level without suspicion of other sources such as infection; 3) signs of pancreatic inflammation on cross-sectional imaging]
Disqualifiers
Age < 18 or > 85 years
Pancreatic endotherapy and/or pancreatic surgery and/or celiac plexus block or neurolysis in last 3 months.
Known hypersensitivity to Pirfenidone
AST and/or ALT > times the upper normal limit
Trial design
Design model
Parallel
Treatments tested in this trial
Pirfenidone 267 mg Oral Tablet
DrugOral tablets taken with food three times daily. Titrated over 14 days: one tablet three times daily in week 1, two tablets three times daily in week 2, and three tablets three times daily (801 mg three times daily) from week 3 onward. Continued for 48 weeks unless reduced or interrupted to manage an adverse event. Dispensed by Investigational Drug Services according to the randomization code.
Placebo
DrugMatching placebo tablets, identical in appearance and packaging to the pirfenidone tablets to maintain double blinding. Administered on the same schedule: one tablet three times daily in week 1, two in week 2, and three from week 3 onward, taken with food, for a total of 48 weeks. Dispensed by Investigational Drug Services according to the randomization code.
PROMIS-Global Health
Other interventionPatient-reported outcome instrument administered to all participants in both arms to assess health-related quality of life. Completed by the participant at Weeks 0, 4, 12, 24, 36, 48, 60, 72, 84 and 96, and at Early Termination.
Comprehensive Pain Assessment Tool
Other interventionPatient-reported outcome instrument administered to all participants in both arms to assess perceived pain. Completed by the participant at Weeks 0, 4, 12, 24, 36, 48, 60, 72, 84 and 96, and at Early Termination.
Brief Pain Inventory
Other interventionPatient-reported outcome instrument administered to all participants in both arms. Administered once per visit and used for two purposes: the pain severity items assess perceived pain, and the pain interference items assess ability to participate in social roles and activities. Completed by the participant at Weeks 0, 4, 12, 24, 36, 48, 60, 72, 84 and 96, and at Early Termination.
Pancreatitis Quality of Life Instrument
Other interventionPatient-reported outcome instrument administered to all participants in both arms to assess ability to participate in social roles and activities. Completed by the participant at Weeks 0, 4, 12, 24, 36, 48, 60, 72, 84 and 96, and at Early Termination.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: PirfenidoneExperimental treatment 5 interventions
Group B: PlaceboPlacebo comparator 5 interventions
Trial outcomes
Primary outcomes
1
Number of Participants With at Least One Grade 3 or Grade 4 Adverse Event as Assessed by CTCAE Version 5.0
Adverse events will be assessed and graded using a modified Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, which grades events from Grade 1, mild, to Grade 5, death related to adverse event. A participant is counted once if one or more adverse events of Grade 3 or Grade 4 are recorded during the treatment period, regardless of how many such events occur. The proportion of participants meeting this criterion will be compared between the pirfenidone and placebo arms.
Time frame
From first dose of study drug through Week 48Secondary outcomes
1
Rate of Pancreatitis-Related Emergency Room Visits Not Requiring Hospital Admission Per Participant-Year
: The total number of emergency room visits attributed to pancreatitis, comprising visits for pancreatic pain, for episodes of acute pancreatitis, or for pancreatitis-related complications, that did not result in hospital admission, divided by the total participant-years of follow-up. Reported as events per participant-year; higher values indicate more frequent visits.
Time frame
From randomization through Week 962
Rate of Pancreatitis-Related Hospital Admissions Per Participant-Year
The total number of hospital admissions attributed to pancreatitis, comprising admissions for pancreatic pain, for episodes of acute pancreatitis, or for pancreatitis-related complications, divided by the total participant-years of follow-up. Reported as events per participant-year; higher values indicate more frequent admissions.
Time frame
From randomization through Week 963
Number of Participants With at Least One Documented Episode of Acute Pancreatitis
An episode of acute pancreatitis is documented by amylase or lipase elevation of two times or more the upper limit of normal, by findings of pancreatic inflammation on cross-sectional imaging, or by clinical diagnosis alone. Episodes are counted whether or not they result in an emergency room visit or hospital admission. A participant is counted once if one or more such episodes occur.
Time frame
From randomization through Week 964
Mean Change From Baseline in PROMIS Global Health Global Physical Health T-Score
The Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health short form is self-completed by the participant. Global Physical Health raw scores are converted to a T-score calibrated so that the United States general population has a mean of 50 and a standard deviation of 10. Higher scores indicate better physical health.
Time frame
Baseline (Week 0), Week 48, and Week 96Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Vikas Dudeja
Lead sponsor
University of Iowa
Sponsor institution
United States Department of Defense
Collaborator
Source ClinicalTrials.gov
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