Simvastatin Treatment to Improve Patient-reported Outcomes in Patients With Chronic Pancreatitis

• Status: Not yet recruiting
• Trial end date: 2026-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this pilot study to examine the feasibility and acceptability of simvastatin in adults with Recurrent Acute Pancreatitis (RAP) and Chronic Pancreatitis (CP).

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cedars-Sinai Medical Center
• Collaborator: United States Department of Defense
• Treatments: Simvastatin

Criteria

Inclusion Criteria:

1. Provision of signed and dated informed consent form

2. Stated willingness to comply with all study procedures and availability for the duration of the study

3. Male or female, aged 18-75 at time of enrollment

4. Diagnosis of Recurrent Acute or Chronic Pancreatitis not attributable to gallstones (i.e., suspected or definite biliary etiology), medications, trauma or autoimmune pancreatitis. For CP, imaging studies that can be used for diagnosis classification using Cambridge criteria46,47.

5. Ability to take oral medication and be willing to adhere to the dosing regimen.

6. For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional one month after administration of study medication.

7. For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional one month after administration of study medication.

8. No prior pancreatic surgery

9. No current statin use for 6 months.

Exclusion Criteria:

1. Pregnancy or lactation

2. History of autoimmune, medication caused or traumatic pancreatitis.

3. Primary pancreatic tumors - pancreatic ductal adenocarcinoma, suspected cystic neoplasm (>1 cm. in size or main duct involvement), neuroendocrine tumors, and other uncommon tumors.

4. Pancreatic metastasis from other malignancies.

5. History of solid organ transplant, HIV/AIDS.

6. Known isolated pancreatic exocrine insufficiency (i.e.., in the absence of any eligible inclusion criteria).

7. Subjects required to take itraconazole, ketoconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, nefazodone, gemfibrozil, cyclosporine, danazol, amiodarone, or verapamil for other clinical indications.

8. Current simvastatin use within the past 6 months.

9. Participants must not have medical or psychiatric illnesses or ongoing substance abuse that in the investigator's opinion would compromise their ability to tolerate study interventions or participate in longitudinal follow up.

10. Patients with active liver disease.

11. Known Pregnancy. All participants of childbearing potential, except if post-menopausal (i.e., no menses for ≥2 years) or had a hysterectomy, bilateral tubal ligation/clip (surgical sterilization) or surgical removal of both the ovaries), must have a negative urine or serum B-HCG pregnancy test documented within 2 days prior to any endoscopic or radiologic procedures done for research purposes. Any standard of care tests will follow institutional policies regarding pregnancy test.

12. Currently incarcerated.

13. Inability to comply with study activities.