Pancreatitis, AcutePhase 1/2NCT05350371
Safety and Tolerability of Pirfenidone in Acute Pancreatitis
A Phase 1/2 study testing Pirfenidone Oral Tablet in people with Pancreatitis, Acute, run by University of Alabama at Birmingham at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Pancreatitis, Acute
- What is being tested?
- Pirfenidone Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Aug 2023to 26 Feb 2026
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 18 - 85 years of age
- Admitted to hospital for AP, defined by at least 2 of the following 3:
- 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- acute onset of a persistent, severe, epigastric pain often radiating to the back
- Patients identified, approached, and consented to administer study medication or placebo within 48 hours of diagnosis of AP.
Show all 12Show fewer
- Predicted to have MSAP or SAP by presence of one or more of the following criteria
- APACHE II ≥ 8
- Modified Glasgow or Imrie score ≥ 3
- CRP > 150 mg/dL
- PASS score > 140 at or within 48 hrs. of admission
- CT or MRI imaging suggesting pancreatic and/or peri-pancreatic necrosis
Who cannot join
- Age < 18 or > 85 years
- Body weight > 200 kg
- Presentation to the medical attention > 48 h after diagnosis of AP
- Inability to recruit, randomize and start the allocated treatment within 48h of start of pain
- Ongoing AP or diagnosis of AP in previous 30 days
- Chronic pancreatitis
Show all 32Show fewer
- Known hypersensitivity to pirfenidone
- AST/ALT ≥ 2 times the upper normal limit.
- Alkaline phosphatase ≥ 2 times the upper normal limit
- Bilirubin higher than upper normal limit
- Moderate to severe heart failure and/or coronary heart disease (New York Heart Association (NYHA) Functional Class III/IV)
- On home oxygen or home mechanical ventilation
- Advanced liver disease
- Paralytic ileus or significant nausea and vomiting
- Chronic Diarrhea
- Immunosuppressive disorder or on immunosuppressive medications
- Active or advanced malignancy
- Known cancer that is end-stage with ongoing palliative care or for which palliative care is appropriate
- Known established infection prior to the onset of acute pancreatitis
- Known history of infective hepatitis
- Known live vaccines or therapeutic infectious agents within one month of admission
- Known pregnancy or lactation at the time of admission
- Ongoing photosensitivity and rash
- Women of childbearing potential who are not on oral or injectable contraceptives or IUDs and do not consent to practice abstinence for period of 4 weeks.
- Known to be currently participating in a trial testing any investigational medicinal product or participation in a clinical study involving a medicinal product in the last three months
- Alcohol or substance abuse in the past 2 years
- Family or personal history of long QT syndrome ( > 500 msec)
- Medications like fluvoxamine or sildanefil
- Significant photosensitivity or new rash
- Renal disease with GFR < 30
- Any condition other than above that, in the opinion of the investigator, is likely to result in the death of the patient within the next 2 years
- Any condition that, in the opinion of the investigator, might be significantly exacerbated by the known side effects associated with the administration of pirfenidone
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UAB
Birmingham, Alabama, 35294
Mayo Clinic
Rochester, Minnesota, 55905
About this study
Official title: Evaluation of Pirfenidone as a Therapy in Patients With Predicted Moderate to Severe Acute Pancreatitis
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:
Read more
- 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.
Read the detailed description
The study is a Randomized Pilot clinical trial evaluating safety and tolerability of pirfenidone in patients with predicted moderately severe to severe acute pancreatitis. There are built in secondary end-points for efficacy. The patients with acute pancreatitis, who present within 48h of establishment of the diagnosis, will be screened for exclusion and inclusion criteria and consented for the clinical trial. Patients with be randomized into placebo or pirfenidone arm and followed daily in-person, while in hospital, and by telephone once discharged from the hospital (weekly for 4 weeks, then monthly for up to 6 months) for study end points.
- Conditions
- Pancreatitis, Acute
- Being tested
- Pirfenidone Oral Tablet, Placebo
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pirfenidone Oral TabletDrug
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.
PlaceboDrug
The placebo tablets will be an exact replica of the pirfenidone tablet.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Experimental | Not described Receives: Drug: Placebo |
| Pirfenidone Treatment | Experimental | Not described Receives: Drug: Pirfenidone Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of Anticipated or Un-anticipated Adverse Events (Class 3 or 4)
Development of anticipated or un-anticipated adverse events (class 3 or 4)
Measured: 6 months
Percentage of Patients Starting and Completion of the Planned Drug Treatment
percentage of patients starting and completion of the planned drug treatment
Measured: 7 days
Changes in C-reactive Protein (CRP), TNF-α, Interleukin (IL)-6, IL-8 and IL-10 Levels
Compared to base line
Measured: 7 days
Percentage of Patients Having Decrease in PAN-PROMISE Score by at Least 10 Points at 72h After Initiation of the Drug
Measurement of PAN-PROMISE score
Measured: 3 days
Secondary outcomes (5)
Cumulative PAN-PROMISE Score
total of the PAN-PROMISE over 7 days
Measured: 7 days
Cumulative PASS Score
total of PASS score during admission
Measured: duration of admission
PASS Score at the Time of Discharge
PASS score measurement
Measured: duration of admission
Composition Outcome
total of development of new or worsening pancreatic or peri-pancreatic necrosis, death or major infection
Measured: 6 months
Readmission and/or ER Visits
Measured: within 30 days and within 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start1 Aug 2023
- Primary completion26 Feb 2026
- Study completion26 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pancreatitis, AcuteStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Mayo Clinic, United States Department of Defense
- Responsible party
- Principal investigator, Nikhil Bush Jayaram, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05350371
- Sponsor's protocol ID
- IRB-300008875
- Other IDs
- W81XMH2110665
- Status last verified
- Feb 2026
- First submitted
- 23 Mar 2022
- Last updated
- 23 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Palathingal Bava E, George J, Tarique M, Iyer S, Sahay P, Gomez Aguilar B, Edwards DB, Giri B, Sethi V, Jain T, Sharma P, Vaish U, C Jacob HK, Ferrantella A, Maynard CL, Saluja AK, Dawra RK, Dudeja V. Pirfenidone increases IL-10 and improves acute pancreatitis in multiple clinically relevant murine models. JCI Insight. 2022 Jan 25;7(2):e141108. doi: 10.1172/jci.insight.141108.
PubMed 34847076Bava EP, Jain T, Al-Obaidi M, Evans Z, Doto D, Vege SS, Dudeja V. Safety, tolerability and therapeutic efficacy of anti-inflammatory drug pirfenidone in acute pancreatitis patients: Protocol for a randomized pilot clinical trial. Pancreatology. 2025 Mar;25(2):214-220. doi: 10.1016/j.pan.2025.01.004. Epub 2025 Jan 13.
PubMed 39864969
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Pirfenidone as a Therapy in Patients With Predicted Moderate to Severe Acute Pancreatitis
- ClinicalTrials.gov ID
- NCT05350371
- Acronym / sponsor ID
- IRB-300008875
- Conditions
- Pancreatitis, Acute
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Mayo Clinic, United States Department of Defense
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 26 Feb 2026 (actual)
- Study completion
- 26 Feb 2026 (actual)
- First posted
- 28 Apr 2022 (actual)
- Results
- Posted 23 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study is a Randomized Pilot clinical trial evaluating safety and tolerability of pirfenidone in patients with predicted moderately severe to severe acute pancreatitis. There are built in secondary end-points for efficacy. The patients with acute pancreatitis, who present within 48h of establishment of the diagnosis, will be screened for exclusion and inclusion criteria and consented for the clinical trial. Patients with be randomized into placebo or pirfenidone arm and followed daily in-person, while in hospital, and by telephone once discharged from the hospital (weekly for 4 weeks, then monthly for up to 6 months) for study end points.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Experimental | Drug: Placebo |
| Pirfenidone Treatment | Experimental | Drug: Pirfenidone Oral Tablet |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients 18 - 85 years of age
- Admitted to hospital for AP, defined by at least 2 of the following 3:
- Patients identified, approached, and consented to administer study medication or placebo within 48 hours of diagnosis of AP.
- Predicted to have MSAP or SAP by presence of one or more of the following criteria
Key exclusion criteria (32 listed)
- Age < 18 or > 85 years
- Body weight > 200 kg
- Presentation to the medical attention > 48 h after diagnosis of AP
- Inability to recruit, randomize and start the allocated treatment within 48h of start of pain
- Ongoing AP or diagnosis of AP in previous 30 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pirfenidone Oral TabletPatients 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 | Pirfenidone Treatment |
| PlaceboThe placebo tablets will be an exact replica of the pirfenidone tablet. | Drug | Placebo |
Primary outcome
Development of Anticipated or Un-anticipated Adverse Events (Class 3 or 4)
Time frame: 6 months
Development of anticipated or un-anticipated adverse events (class 3 or 4)
Percentage of Patients Starting and Completion of the Planned Drug Treatment
Time frame: 7 days
percentage of patients starting and completion of the planned drug treatment
Changes in C-reactive Protein (CRP), TNF-α, Interleukin (IL)-6, IL-8 and IL-10 Levels
Time frame: 7 days
Compared to base line
Percentage of Patients Having Decrease in PAN-PROMISE Score by at Least 10 Points at 72h After Initiation of the Drug
Time frame: 3 days
Measurement of PAN-PROMISE score
5 secondary outcomes
Cumulative PAN-PROMISE Score
Time frame: 7 days
Cumulative PASS Score
Time frame: duration of admission
PASS Score at the Time of Discharge
Time frame: duration of admission
Composition Outcome
Time frame: 6 months
Readmission and/or ER Visits
Time frame: within 30 days and within 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 34847076Palathingal Bava E, George J, Tarique M, Iyer S, Sahay P, Gomez Aguilar B, Edwards DB, Giri B, Sethi V, Jain T, Sharma P, Vaish U, C Jacob HK, Ferrantella A, Maynard CL, Saluja AK, Dawra RK, Dudeja V. Pirfenidone increases IL-10 and improves acute pancreatitis in multiple clinically relevant murine models. JCI Insight. 2022 Jan 25;7(2):e141108. doi: 10.1172/jci.insight.141108.
- Derived from this study: PubMed 39864969Bava EP, Jain T, Al-Obaidi M, Evans Z, Doto D, Vege SS, Dudeja V. Safety, tolerability and therapeutic efficacy of anti-inflammatory drug pirfenidone in acute pancreatitis patients: Protocol for a randomized pilot clinical trial. Pancreatology. 2025 Mar;25(2):214-220. doi: 10.1016/j.pan.2025.01.004. Epub 2025 Jan 13.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Pirfenidone Oral Tablet in people with Pancreatitis, Acute, run by University of Alabama at Birmingham at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of Anticipated or Un-anticipated Adverse Events (Class 3 or 4) (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05350371, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.