Phase
Condition
Pancreatitis
Primary Biliary Cholangitis
Treatment
Placebo
Paricalcitol
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for theduration 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 autoimmunepancreatitis.
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 atleast 1 month prior to screening and agreement to use such a method during studyparticipation and for an additional 1 week after the end of Investigational Productadministration
For males of reproductive potential: use of condoms or other methods to ensureeffective 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 ofenrollment
Exclusion
Exclusion Criteria:
Pregnancy or lactation
History of autoimmune or traumatic pancreatitis, or sentinel attack of acutenecrotizing pancreatitis which results in suspected disconnected duct syndrome
Primary pancreatic tumors - pancreatic ductal adenocarcinoma, suspected cysticneoplasm (>1 cms in size or main duct involvement), neuroendocrine tumors, and otheruncommon 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 anyeligible inclusion criteria)
Participants must not have medical or psychiatric illnesses or ongoing substanceabuse that in the investigator's opinion would compromise their ability to toleratestudy interventions or participate in longitudinal follow up
Patients with known abnormal creatinine (GFR < 30) or renal failure (applies topatients with chronic upper abdominal pain of suspected pancreatic origin andsuspected CP.
Known Pregnancy. All participants of childbearing potential, except ifpost-menopausal [i.e. no menses for ≥2 years] or had a hysterectomy, bilateral tuballigation/clip (surgical sterilization) or surgical removal of both the ovaries),must have a negative urine or serum B-HCG pregnancy test documented within 2 daysprior to any endoscopic or radiologic procedures done for research purposes. Anystandard of care tests will follow institutional policies regarding pregnancy test
Currently incarcerated
Inability to tolerate MRI
Study Design
Study Description
Connect with a study center
Cedars-Sinai Medical Center
Los Angeles, California 90048
United StatesActive - Recruiting
Marissa Maiman
Los Angeles, California 90048
United StatesActive - Recruiting
Marissa Podell
Los Angeles, California 90048
United StatesActive - Recruiting
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