Two US Clinical Trials from Brigham and Women's Hospital

More participants are needed for the following drug trials to move forward. Please reach out to the Brigham and Women’s researchers directly if you are interested or have questions. Contact information follows each trial description.

Thank you to all who are willing and able to participate in this way!

SHIP trial: Sulfasalazine in PSC with IBD and high ALP

The SHIP study is investigating the efficacy of a drug called sulfasalazine, and the team is looking to enroll patients ages 15-80 with PSC and IBD who report abnormally high alkaline phosphatase (ALP) levels (>1.67 x the upper limit of normal) and have no known sulfa allergy. Additional inclusion and exclusion criteria can be found here. The team is recruiting remotely throughout the United States, so an individual anywhere in the U.S. with PSC/IBD can be enrolled if they meet the criteria.

Participation in the study will take from 14 to 18 weeks, with the opportunity to continue taking the drug open label after the initial study period is over. Participants will need to attend seven study visits, all of which can be remote.

Participation will involve taking an oral medication twice daily, tracking the medication in a log, and getting blood drawn for a few lab tests throughout the study. For further questions and interest in the SHIP study, please reach out to the study coordinator directly via email at sbhalerao3@bwh.harvard.edu or by phone at (737) 302-1359.

DoLPHin trial: Hydroxocobalamin in PSC with high ALP

The DolPHin study is an 8-week study testing the efficacy of a drug called hydroxocobalamin as a treatment for patients with PSC. All the study visits will take place remotely, and blood will be drawn by a research nurse who will visit the trial participants in their home.

Dr. Korzenik is looking to enroll adults 18 and over with PSC who have high alkaline phosphatase levels (>1.50 x the upper limit of normal) and who live in the U.S. Additional criteria apply; please check eligibility inclusion and exclusion criteria here. To ensure eligibility, lab tests may be needed.

The goal of the DoLPHin study is to determine the preferable dosing of hydroxocobalamin in patients with PSC. Thirty-two patients will be enrolled into four successive groups in a crossover, placebo-controlled design.

Patients will complete nine study visits over the course of up to 12 weeks. All study visits will be conducted by video/virtual visits or by a mobile research nurse, and a combination of blood tests, stool tests, urine tests, and questionnaires will be used to assess the effect of the drug over the course of the study. 

For further questions and interest in the study, please reach out to the study coordinator directly via email at smitchell22@bwh.harvard.edu or by phone at (508) 936-3674.