A PiLot ClinicaL TrIal of ParicAlcitol for ChroNiC PancrEatitis

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Early Phase 1
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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

Locations
United States
California
Cedars-Sinai Medical Center
RECRUITING
Los Angeles
Contact Information
Primary
Arax Shanlian
arax.shanlian@cshs.org
3109671110
Time Frame
Start Date: 2023-06-01
Estimated Completion Date: 2026-12
Participants
Target number of participants: 24
Treatments
Experimental: Paricalcitol
Participants receive Paricalcitol 2mcg capsule once daily for 12 months.
Placebo_comparator: Placebo
Participants receive Paricalcitol Placebo capsule matching Paricalcitol once daily for 12 months.
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Leads: Cedars-Sinai Medical Center

This content was sourced from clinicaltrials.gov