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Not Yet Recruiting NCT05664880

A PiLot ClinicaL TrIal of ParicAlcitol for ChroNiC PancrEatitis

Conditions: Chronic Pancreatitis

Sex: All
Ages: 18 Years – 75 Years
Phase: EARLY_PHASE1
Enrollment: 24
Sponsor: Cedars-Sinai Medical Center

Location: United States

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 formStated willingness to comply with all study procedures and availability for the duration of the studyMale or female, aged 18-75 at time of enrollmentDiagnosis 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 regimenNormal Calcium levels- 8.5 to 10.2 mg/dLNormal Phosphate levels- 2.8 to 4.5 mg/dLNormal Parathyroid hormone levels- 10 to 65 pg/mLFor 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 administrationFor males of reproductive potential: use of condoms or other methods to ensure effective contraception with partnerNo prior pancreatic surgeryPancreatic necrosis, if present, is <50% (to be verified by a CPDPC site radiologist)No involvement in any interventional trials currently or within 6 months of enrollmentExclusion Criteria:Pregnancy or lactationHistory of autoimmune or traumatic pancreatitis, or sentinel attack of acute necrotizing pancreatitis which results in suspected disconnected duct syndromePrimary 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 malignanciesHistory of solid organ transplant, HIV/AIDS.Abnormal lab values: calcium, phosphate, or parathyroid hormoneKnown 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 upPatients 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 testCurrently incarceratedInability to tolerate MRI

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05664880). StuddyBuddy aggregates publicly available trial information.