Is NCT06253117 recruiting in Birmingham, AL?

Yes, NCT06253117 is currently recruiting participants at its Birmingham, AL location. This acute pancreatitis clinical trial is actively enrolling qualified participants.

How do I join the acute pancreatitis clinical trial in Birmingham?

To join this clinical trial in Birmingham, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Birmingham clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Acute Pancreatitis Clinical Trial in Birmingham, AL

Who Can Participate

Inclusion Criteria

Patients 18 - 85 years of age

Two or more documented attacks of acute pancreatitis, separated by 3 months from one another, 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 according to the revised Atlanta classification28

Drug/placebo treatment to start

Mild AP Patient is discharged out of the hospital 30 days after diagnosis of mild AP

Moderate Severe or Severe AP Patient is discharged out of hospital Intra-abdominal collections are either resolved on imaging, or are improving and asymptomatic (VAS Pain score ≤3 \[with or without pain medication\], vomiting ≤once a week, tolerating light diet, and no fever and chills) and do not warrant any intervention (per treating physician)

Ability to understand and the willingness to sign a written informed consent document and medical release

Willing and able to comply with trial protocol and follow up

2nd AP episode despite correction of the AP etiology (if identified) after the 1st episode as follows i. Patients with biliary pancreatitis who have undergone cholecystectomy, with or without ERCP (if indicated) ii. Patients with hypertriglyceridemia induced pancreatitis who have serum triglyceride levels below 400 while on medication management iii. Patients with medication induced AP developing a 2nd AP episode despite stopping the culprit medication B-

Exclusion Criteria

Age \< 18 or \> 85 years.

Body weight \> 200 kg.

Ongoing AP (in right clinical situation defined by pain\>3, vomiting ≥once a week, fever or chills, not tolerating light diet) or diagnosis of AP in previous 30 days.

Diagnosis of chronic pancreatitis, one of the following

Ductal stricture, calcification and/or atrophy, as seen on CT scan/MRI

5 or more of the 9 EUS criteria used to diagnose CP

Known hypersensitivity to Pirfenidone.

AST/ALT \> 3 times the upper normal limit.

Alkaline phosphatase \>2.5 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 as defined by Child-Pugh cirrhosis B or C.

Paralytic ileus or significant nausea and vomiting preventing administration of light diet.

Chronic diarrhea (\>6 months, 3 or more stools/day-Clinically not appearing to be steatorrhea \[fecal fat if done less than 15 g per day and fecal elastase if done more than 100\].Active cancer (on chemotherapy, radiation or treatment of cancer at the time of enrollment) or cancer free \<3 years (non-melanoma skin cancer are not a contraindication)

Known cancer that is end-stage with ongoing palliative care or for which palliative care is appropriate.

Known history of infective hepatitis (Hepatitis B or C)\[can enroll if treatment and cure is documented\]

Ongoing photosensitivity and rash.

Known live vaccines or therapeutic infectious agents within one month of admission.

Known pregnancy or lactation at the time of admission.

Women of childbearing potential who are not on oral or injectable contraceptives or IUDs, and do not consent to adequate contraception while on, and for 90 days after the administration of the drug/placebo.

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.

Problematic pattern of alcohol use or moderate to severe alcohol use disorder (Appendix 2)

Substance use disorder (except recreational or medicinal use of marijuana) \[if patient underwent and completed a rehab program, has not used substances for at least one year, and has an adequate support system, they may be enrolled\]

Family or personal history of long QT syndrome (\> 500 msec).

Strong CYP1A2 inhibitors (e.g., fluvoxamine, enoxacin) or moderate CYP1A2 Inhibitors (e.g., ciprofloxacin).

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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Birmingham?

Yes, this clinical trial (NCT06253117) has an active research site in Birmingham, AL that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Acute Pancreatitis Treatment Options in Birmingham, AL

If you're searching for acute pancreatitis treatment options in Birmingham, AL, this clinical trial (NCT06253117) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Birmingham research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced acute pancreatitis specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all acute pancreatitis clinical trials near you to find additional studies recruiting in your area.

Acute Pancreatitis Clinical Trial in Birmingham, AL

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