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Tests treatment safety and results for Pancreatitis, Acute
Official title Safety and Tolerability of Pirfenidone in Acute Pancreatitis
ClinicalTrials.gov ID: NCT05350371
What this study is testing
What is Pirfenidone Oral Tablet?
Pirfenidone Oral Tablet is an investigational medicine, given as an once-weekly pill taken by mouth, being studied as a potential treatment for pancreatitis, acute.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 5 years
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- 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
You likely can't join if
- Age \ 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
See the full eligibility criteria
- 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.
- 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
- Age \ 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Rochester, Minnesota, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 5 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Rochester, Minnesota, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.