UCSF home page UCSF home page About UCSF UCSF Medical Center
UCSF navigation bar
photos

Clinical Trials

The UCSF Division of Gastroenterology conducts many clinical trials. The following are ongoing clinical trials in which patient enrollment is open:

UCSF Center for Colitis and Crohn’s
Crohn’s Disease
A Randomized, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to-Severely Active Crohn’s Disease (Phase III) Investigational product is an orally-administered small molecule chemokine receptor antagonist which specifically blocks the migration of gut-specific T cells, which selectively home to the intestine. Blinded study is followed up by maintenance protocol with open-label arm. For more information, please contact Yelena Idomsky RN at 415-353-7871 or Yelena.idomsky@ucsfmedctr.org.
A Phase III, multicenter, placebo-controlled, randomized, double-blind study to evaluate the safety and efficacy of PROCHYMAL™ (ex vivo cultured adult human mesenchymal stem cells) intravenous infusion for the induction of remission in subjects experiencing treatment-refractory moderate-to-severe Crohn’s disease. The protocol investigates the safety and efficacy of using PROCHYMAL™ adult human stem cells to induce remission. PROCHYMAL™ is delivered IV four times over two weeks, for approximately an hour each time. A course of open-label PROCHYMAL treatment will be available to all subjects who enroll in this protocol. For more information, please contact Yelena Idomsky RN at 415-353-7871 or Yelena.idomsky@ucsfmedctr.org.
A randomized, double-blind, placebo-controlled study of the efficacy and safety of metronidazole ointment in symptomatic perianal Crohn’s disease (Phase II) Topical administration of either metronidazole 20% ointment, metronidazole 10% ointment or placebo in a ratio of 1:1:1.The primary objective of this study is to determine the effects of metronidazole ointment on perianal pain associated with active perianal Crohn’s disease. For more information, please contact Yelena Idomsky RN at 415-353-7871 or Yelena.idomsky@ucsfmedctr.org.
A double-blind, randomized, placebo-controlled, dose-ranging study to evaluate the efficacy and safety of PF-04236921 in subjects with Crohn’s disease who are Anti-TNF inadequate responders (ANDANTE) (Phase II) This is a Phase 2 study with subcutaneously administered IL-6 compound. Blinded study is followed up by open-label extension. The primary objectives of this study are to demonstrate clinical activity of PF-04236921 that will induce a clinical response and remission in subjects with Crohn’s Disease (CD) and to select dose(s) for future clinical studies. For more information, please contact Yelena Idomsky RN at 415-353-7871 or Yelena.idomsky@ucsfmedctr.org.
A Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study of Daikenchuto (TU-100) in Subjects with Moderate Crohn’s Disease (Phase II) TU-100, an herbal product manufactured by Tsumura & Co (Tokyo, Japan), is a granular formulation of Daikenchuto. The primary objective of this study is evaluate the induction of a clinical response of moderate (Crohn’s Disease Activity Index (CDAI): 220-300) Crohn’s disease in adult subjects following a total daily oral dose of 15 g TU-100 administered for 8 consecutive weeks. For more information, please contact Yelena Idomsky RN at 415-353-7871 or Yelena.idomsky@ucsfmedctr.org.
Utility of Adalimumab Levels for Crohn’s Disease Patients on adalimumab (Humira) have blood drawn to test the level of drug in their body. The goal of this study is to determine if there is a level of adalimumab in blood that is correlated with remission so that patient's drug dose can be appropriately adjusted. For more information, please contact Yelena Idomsky RN at 415-353-7871 or Yelena.idomsky@ucsfmedctr.org.
Ulcerative Colitis
A phase 2 randomized, double-blind, placebo-controlled, parallel group, multi-center study to investigate the safety and efficacy of MULTISTEM (PF-05285401) in subjects with Moderate to severe Ulcerative Colitis. PF-05285401, also known as MultiStem®, is a cell-based, biological therapy under development for the treatment of ulcerative colitis (UC). MultiStem is manufactured from human stem cells obtained from adult bone marrow. The study is designed to evaluate the safety and tolerability of multiple intravenous doses of MultiStem in moderate-to-severe ulcerative colitis and to study the efficacy of multiple intravenous doses of MultiStem in moderate-to-severe ulcerative colitis. For more information, please contact Yelena Idomsky RN at 415-353-7871 or Yelena.idomsky@ucsfmedctr.org.
Randomized, double-blind, prospective trial investigating the efficacy of Methotrexate in induction and maintenance of steroid free remission in ulcerative colitis. (Methotrexate Response in Treatment of Ulcerative Colitis - MERIT-UC) (Phase II) The study comprises an open label Induction Period of 16 weeks and a placebo controlled Maintenance Period of 32 weeks. In the Induction Period the study subject will be treated with MTX 25 mg/once weekly and either a prednisone-tapering schedule for 10-12 weeks starting at 40 mg or 20 mg depending on the need for steroids 2 weeks before inclusion in the study. If study subject has responded or is in remission and is off steroids after 16 weeks of therapy with MTX 25 mg/weekly, the study subject will be randomized to either MTX 25 mg/weekly* or placebo until week 48. For more information, please contact Yelena Idomsky RN at 415-353-7871 or Yelena.idomsky@ucsfmedctr.org.
Inflammatory Bowel Disease
PIANO: A Multicenter National Prospective Study of Pregnancy and Neonatal Outcomes in Women with Inflammatory Bowel Disease This study recruits pregnant women with IBD and follows them and their infants through pregnancy and the first 4 years of life. The goal of this study is to determine if the use of certain medications leads to an increase in birth defects, infections, developmental delay and other complications. This is purely a questionnaire based study and is done via phone and internet. For more information, please contact Yelena Idomsky RN at 415-353-7871 or Yelena.idomsky@ucsfmedctr.org.
Study of the Environmental and Gastrointestinal Microbiome in South Asians with IBD. This study recruits patients from South Asia who are migrants to the US and have developed IBD. Subjects will answer an extensive environmental questionnaire on diet and other factors and provide a sample for microbiome testing. For more information, please contact Yelena Idomsky RN at 415-353-7871 or Yelena.idomsky@ucsfmedctr.org.

To search for active clinical trials related to GI and Liver at UCSF please visit the UCSF Health website.