Combination Therapy With Ursodeoxycholic Acid (UDCA) and All-Trans Retinoic Acid (ATRA) for Treatment of Primary Sclerosing Cholangitis

PHASE1CompletedINTERVENTIONAL
Enrollment

19

Participants

Timeline

Start Date

October 31, 2011

Primary Completion Date

June 30, 2014

Study Completion Date

December 31, 2015

Conditions
Cholangitis, Sclerosing
Interventions
DRUG

Oral all-trans retinoic acid (ATRA)

"The subjects will continue to take their current dose of UDCA (15 mg/kg/day), as per ongoing clinical care, and need to be on a stable dose of UDCA for at least six months prior to enrollment.~The specific intervention is the addition of daily oral ATRA (45 mg/m\^2) divided into 2 doses. To increase adherence to the dosing regimen, the drug will be compounded by the Research Pharmacies of Yale and Mayo into 2 formulations (30 mg and 40 mg capsules), and an Investigational New Drug (IND) permit was obtained for this process."

Trial Locations (2)

55905

Mayo Clinic, Rochester

06520

Yale University School of Medicine - 333 Cedar St - 1080 LMP, New Haven

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Mayo Clinic

OTHER

lead

Yale University

OTHER