A Phase 2 interventional study of Pirfenidone 267 mg Oral Tablet and Placebo in Chronic Pancreatitis, sponsored by Vikas Dudeja. Not yet recruiting. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-08-10.
Sponsored by Vikas Dudeja · Phase 2, Interventional, and Treatment
The proposed project is focused towards evaluation of Pirfenidone as a novel therapeutic strategy in patients with chronic pancreatitis (CP).
This is a multi-institutional, double-blind, placebo-controlled clinical trial of the safety, tolerability and efficacy of Pirfenidone in patients with CP. Patients with a confirmed diagnosis of CP will be randomly assigned to Pirfenidone or placebo (2:1 randomization). The assigned allocation (drug or placebo) will be continued for 48 weeks.
Subjects will be asked to complete questionnaires, have blood draws, and will be randomized to either the IP or placebo. They will have both in person and telephone/remote visits.
264 studies on the registry are indexed under Pancreatitis, Chronic; 76 are open to participants now.
This study's planned enrollment of 60 is above the median of 45 across 143 interventional studies indexed under Pancreatitis, Chronic.
Browse Pancreatitis, Chronic studies →This is the only study on the registry with Vikas Dudeja as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
All subjects will be diagnosed with chronic pancreatitis (CP).
Inclusion Criteria:
Diagnosis of CP, based on at least one of the following on CT and/or MRI/MRCP:
Exclusion Criteria
All participants of childbearing potential, except if [see definition of menopause below] or had a hysterectomy, bilateral tubal ligation/clip (surgical sterilization) or surgical removal of both the ovaries), must have a negative urine pregnancy test documented within 2 days prior to initiation of the study drug.
Menopause can be assumed to have occurred when there is either:
A) Either twelve [12] months of spontaneous amenorrhea; or B) six [6] months of spontaneous amenorrhea with serum FSH levels > 40 mIU/mL; or C) six [6] weeks postsurgical bilateral oophorectomy with or without hysterectomy.
Hormonal deficiency will be documented in the case of suspected spontaneous menopause as follows:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive pirfenidone 267 mg oral tablets, taken with food three times daily. The dose is titrated over 14 days: one tablet three times daily during week 1, two tablets three times daily during week 2, and three tablets three times daily (801 mg three times daily) from week 3 onward. Treatment continues for a total of 48 weeks. All participants in this arm also complete the PROMIS-Global Health, COMPAT-SF, Brief Pain Inventory, and PANQOLI role function subscale instruments at Weeks 0, 4, 12, 24, 36, 48, 60, 72, 84 and 96.
Drug: Pirfenidone 267 mg Oral Tablet · Other: PROMIS-Global Health · Other: Comprehensive Pain Assessment Tool · Other: Brief Pain Inventory · Other: Pancreatitis Quality of Life Instrument
Participants receive matching placebo oral tablets, taken with food three times daily. The number of tablets follows the same schedule as the pirfenidone arm over 14 days: one tablet three times daily during week 1, two tablets three times daily during week 2, and three tablets three times daily from week 3 onward. Treatment continues for a total of 48 weeks. All participants in this arm also complete the PROMIS-Global Health, COMPAT-SF, Brief Pain Inventory, and PANQOLI role function subscale instruments at Weeks 0, 4, 12, 24, 36, 48, 60, 72, 84 and 96.
Drug: Placebo · Other: PROMIS-Global Health · Other: Comprehensive Pain Assessment Tool · Other: Brief Pain Inventory · Other: Pancreatitis Quality of Life Instrument
Oral 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.
Matching 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.
Patient-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.
Also known as: PROMIS-GH
Patient-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.
Also known as: COMPAT-SF
Patient-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.
Also known as: BPI
Patient-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.
Also known as: PANQOLI
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 48
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 96
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 96
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 96
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 96
Mean Change From Baseline in PROMIS Global Health Global Mental Health T-Score
The Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health short form is self-completed by the participant. Global Mental 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 mental health.
Time frame: Baseline (Week 0), Week 48, and Week 96
Mean Change From Baseline in Comprehensive Pain Assessment Tool Short Form (COMPAT-SF) Total Score
The Comprehensive Pain Assessment Tool Short Form is a pancreatitis-specific multidimensional pain instrument self-completed by the participant. Higher scores indicate greater pain burden.
Time frame: Baseline (Week 0), Week 48, and Week 96
Mean Change From Baseline in Brief Pain Inventory Pain Severity Score
The Brief Pain Inventory is self-completed by the participant. The four pain severity items are each scored from 0, no pain, to 10, pain as bad as you can imagine, and are averaged to produce a severity score ranging from 0 to 10. Higher scores indicate greater pain severity.
Time frame: Baseline (Week 0), Week 48, and Week 96
Mean Change From Baseline in PANQOLI Role Function Subscale Score
The role function subscale of the Pancreatitis Quality of Life Instrument (PANQOLI) is self-completed by the participant.
Time frame: Baseline (Week 0), Week 48, and Week 96
Mean Change From Baseline in Opioid Use Measured in Morphine Milligram Equivalents
Opioid dispensing records are obtained from the Prescription Drug Monitoring Program with participant consent and are complemented by participant-reported intake. Total opioid consumption over the 30 days preceding each assessment is converted to morphine milligram equivalents using established conversion factors. Higher values indicate greater opioid use.
Time frame: The 30 days preceding Baseline (Week 0), Week 48, and Week 96
Number of Participants With a New Diagnosis of Pancreatic Endocrine Dysfunction
Endocrine status is determined by hemoglobin A1c and by fasting or random blood glucose, interpreted by the investigator. A new diagnosis is recorded where the investigator determines that endocrine dysfunction is present at an assessment timepoint in a participant who did not have a diagnosis of diabetes at Week 0. A participant is counted once.
Time frame: Baseline (Week 0), Week 48, and Week 96
Number of Participants With a New Diagnosis of Pancreatic Exocrine Dysfunction
Exocrine status is determined by fecal elastase measured on a participant-collected stool specimen. A new diagnosis is recorded where the investigator determines that exocrine insufficiency is present at an assessment timepoint in a participant who did not have exocrine insufficiency at the first timepoint. A participant is counted once.
Time frame: Within 2 months after first dose of study drug, at Week 48, and at Week 96
No study locations are listed for this record.
Plan to share: Yes — Results will be published in clinicaltrials.gov
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: One year following the primary completion date.
No publications or documents are linked to this record.
Start is estimated for Aug 2026; primary completion for Aug 2030, 48 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Pirfenidone