NCT05664880 A PiLot ClinicaL TrIal of ParicAlcitol for ChroNiC PancrEatitis
| NCT ID | NCT05664880 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Cedars-Sinai Medical Center |
| Condition | Chronic Pancreatitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2023-06-01 |
| Primary Completion | 2026-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 24 participants in total. It began in 2023-06-01 with a primary completion date of 2026-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this pilot study to examine the feasibility and acceptability of paricalcitol in adults with Chronic Pancreatitis (CP).
Eligibility Criteria
Inclusion Criteria: * Provision of signed and dated informed consent form * Stated willingness to comply with all study procedures and availability for the duration of the study * Male or female, aged 18-75 at time of enrollment * Diagnosis of Chronic Pancreatitis episode is not attributable to gallstones (i.e. suspected or definite biliary etiology), medications, trauma or autoimmune pancreatitis. * Ability to take oral medication and be willing to adhere to the dosing regimen * Normal Calcium levels- 8.5 to 10.2 mg/dL * Normal Phosphate levels- 2.8 to 4.5 mg/dL * Normal Parathyroid hormone levels- 10 to 65 pg/mL * 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 1 week after the end of Investigational Product administration * For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner * No prior pancreatic surgery * Pancreatic necrosis, if present, is \<50% (to be verified by radiologist) * No involvement in any interventional trials currently or within 6 months of enrollment Exclusion Criteria: * Pregnancy or lactation * History of autoimmune or traumatic pancreatitis, or sentinel attack of acute necrotizing pancreatitis which results in suspected disconnected duct syndrome * Primary pancreatic tumors - pancreatic ductal adenocarcinoma, suspected cystic neoplasm (\>1 cms in size or main duct involvement), neuroendocrine tumors, and other uncommon tumors. * Pancreatic metastasis from other malignancies * History of solid organ transplant, HIV/AIDS. * Abnormal lab values: calcium, phosphate, or parathyroid hormone * Known isolated pancreatic exocrine insufficiency (e.g. in the absence of any eligible inclusion criteria) * 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 * Patients with known abnormal creatinine (GFR \< 30) or renal failure (applies to patients with chronic upper abdominal pain of suspected pancreatic origin and suspected CP. * 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 * Currently incarcerated * Inability to tolerate MRI
Contact & Investigator
Stephen Pandol, MD
PRINCIPAL INVESTIGATOR
Cedars-Sinai Medical Center
Frequently Asked Questions
Who can join the NCT05664880 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Chronic Pancreatitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05664880 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05664880 currently recruiting?
Yes, NCT05664880 is actively recruiting participants. Contact the research team at arax.shanlian@cshs.org for enrollment information.
Where is the NCT05664880 trial being conducted?
This trial is being conducted at Los Angeles, United States.
Who is sponsoring the NCT05664880 clinical trial?
NCT05664880 is sponsored by Cedars-Sinai Medical Center. The principal investigator is Stephen Pandol, MD at Cedars-Sinai Medical Center. The trial plans to enroll 24 participants.