• Risk Stratification and Identification of Immunogenetic and Microbial Markers of Complicated Disease Course in Pediatric Crohn’s Disease (CD) sponsored by the CCFA (patients in follow-up, no longer enrolling)

• Causes and consequences of neutrophil dysfunction in early onset Crohn’s Disease (CD) sponsored by the NIDDK (patients in follow-up)

• Risk Stratification and Partners Kids and Teens Study of Linkage and Internet Based Cohort for Ulcerative Colitis (UC) or Crohn’s Disease (CD) sponsored by the CCFA (patients in follow-up, no longer enrolling)

• A Phase 3, Double-Blind, Placebo Controlled, Multicenter Study of the Efficacy and Safety of Etrolizumab During Induction and Maintenance in Adult Patients with Moderate to Severe Active Ulcerative Colitis who are Refractory to or Intolerant of TNF Inhibitors sponsored by Genentech (now enrolling)

• A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Etrolizumab as an Induction and Maintenance Treatment for Patients with Moderately to Severely Active Crohn's Disease sponsored by Genentech (now enrolling)

• A Phase 3, Double-Blind, Placebo Controlled, Multicenter Study of the Efficacy and Safety of Etrolizumab During Induction and Maintenance in Adult Patients with Moderate to Severe Active Ulcerative Colitis who are Naïve to TNF Inhibitors sponsored by Genentech (now enrolling)

• A Long-Term Non-Interventional Registry to Assess Safety and Effectiveness of Humira® (Adalimumab) in Pediatric Patients with Moderately to Severely Active Crohn's Disease (CD) – CAPE sponsored by AbbVie (now enrolling)

• A Phase 4, Multicenter, Open-label Study of Serum Infliximab Concentrations and Efficacy and Safety of Dose Escalation in Pediatric Patients with Inflammatory Bowel Disease sponsored by Janssen Pharmaceuticals (now enrolling)

• Predicting Response to Standardized Pediatric Colitis Therapy: The PROTECT Study for Children with Newly Diagnosed Ulcerative Colitis (UC) sponsored by the NIH (patients in follow-up, no longer enrolling)

• A Phase 1b Open-Label Trial to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a human anti-TNFα Antibody, In Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis (UC) sponsored by Janssen Pharmaceuticals (patients in follow-up, no longer enrolling)

• A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Ulcerative Colitis sponsored by AbbVie (now enrolling)

• Quality Improvement Initiative called Improve Care Now (ICN) in Inflammatory Bowel Disease (IBD) sponsored by UCSF Medical Center (now enrolling)

• A Multicenter, Prospective, Long-term, Observational Registry of Pediatric Patients with Inflammatory Bowel Disease (IBD) sponsored by Janssen Pharmaceuticals (patients in follow-up, enrolling UC and IC patients)

• Telehealth Enhancement of Adherence to Medication (TEAM study) in Pediatric Inflammatory Bowel Disease (IBD) in collaboration with CCHMC sponsored by the NIH (patients in follow-up, no longer enrolling)

• The Orchestra Pilot Project: Enhancing Patient-Provider Partnerships Using The Orchestra Platform (now enrolling)

• Viral Community in Pediatric Inflammatory Bowel Disease (IBD) Patients (study completed)

• The S1P Study: A Study of Obesity, Genetics and Cancer in Pediatric Inflammatory Bowel Disease (IBD) in patients aged 1-25 undergoing a colonoscopy (now enrolling)

• INSPPIRE is a multi-center, prospective registry of children with acute recurrent and chronic pancreatitis. The goal of the study is to understand the causes and progression of pancreatitis in children, and to create a group in which new treatments can be developed to reduce pain, hospitalizations, and diabetes and to improve quality of life (Enrolling)

• A Multicentre, Randomized, Placebo-controlled, Double-blind Study of the Efficacy, Safety, and Pharmacokinetics of Lubiprostone in Pediatric Subjects Aged ≥ 6 Years to < 18 Years with Functional Constipation (Phase 3 Trial) as well as a Multicentre, Long-Term Safety, Efficacy, and Pharmacokinetics Study of Lubiprostone in Pediatric Subjects Aged ≥ 6 Years to < 18 Years with Functional Constipation sponsored by Sucampo AG (patient in follow-up)

• A prospective, multi-center registry for pediatric patients with short bowel syndrome. The purpose of this registry is to evaluate long-term clinical outcomes in children with SBS, both those treated with Teduglutide and those not treated with Teduglutide (TED-R13-002) sponsored by Shire (Enrolling soon)

• A 24-week Double-blind, Safety, Efficacy, and Pharmacodynamic Study Investigating Two Doses of Teduglutide in Pediatric Subjects Through 17 Years of Age with Short Bowel Syndrome who are Dependent on Parenteral Support (TED-C14-006) sponsored by Shire (Enrolling soon)

For more information about the latest research studies at UCSF, please contact Liz Garnett at (415) 514-4423 or via email [email protected]

New Studies

Childhood Obesity and Sugar Sweetened Beverage Consumption in Huslia, Alaska and Old Crow, Canada: A Pilot, Fieldwork Study (supported by the Pacific Rim Research Program). This study compared consumption patterns among children in locations with the highest amounts of sugar sweetened beverages, and assessed attitudes toward fast food consumption as a secondary outcome.

Risk Factors for Infant Overweight in a Latino Cohort (supported by grants from NIH/NIDDK and the Allen Foundation). This study examines the relationship between maternal depression and risk for obesity in Latino children while also evaluating levels of insulin-like growth factor (IGF-1), leptin, ghrelin and insulin at birth and two years of age.

Ongoing Studies

Maternal Depression and Child Weight Gain in a Latino Cohort (supported by grants from HIH/NIDDK, the Hellman Family Foundation and CDHNF/Nestle). This study evaluates prenatal and postnatal depression exposures and other early life environmental exposures in relation to risk for development of childhood overweight and obesity.

The Use of the Resperate Device in Obese Children (supported by a grant from UCSF's Center for Health and Community). This study evaluates the qualitative experience of the use of the Resperate device, a clinically proven device to lower blood pressure in adults, in obese children.

An Evaluation of a Fruit Distribution Program at Balboa High School, San Francisco (In conjunction with the SFUSD Committee on Nutrition and Physical Activity).

Maternal and Adolescent Nutritional Knowledge, Dietary Behaviors and Participation in the WIC Supplemental Food Program (Supported by the UC Davis/ERS RIDGE Small Grant Program in Nutrition).

For more information, please contact
Janet Wojcicki at (415) 476-2380 or via email

New Studies

A Randomized, Double-Blind Evaluation of the Antiviral Efficacy, Safety and Tolerability of Tenofovir Disoproxil Fumarate Vs. Placebo in Pediatric Patients with Chronic HBV Infection – Sponsored by Gilead

A Phase 2, Open-Label, Multicenter, Multi-cohort Study to Investigate the Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination in Adolescents and Children with Chronic HCV Infection (GS1116) - Sponsored by Gilead Sciences, Inc.

A Phase 2, Open-Label, Multicenter, Multi-cohort, Single-Arm Study to Investigate the Safety and Efficacy of Sofosbuvir + Ribavirin in Adolescents and Children with Genotype 2 or 3 Chronic HCV Infection (GS1112) – Sponsored by Gilead Sciences, Inc.

An Open-Label Multicenter Study to Evaluate the Pharmacokinetics, Safety, and Efficacy of Ombitasvir (OBV), Paritaprevir (PTV), Ritonavir (RTV) With or Without Dasabuvir (DSV) and With or Without Ribavirin (RBV) in Pediatric Subjects with Genotype 1 or 4 Chronic Hepatitis C Virus Infection – Sponsored by Abbvie

Ongoing Studies

STOPSC- Studies of Primary Sclerosing Cholangitis – a multi-center database to further the understanding of AIH and PSC in children.

Non-Alcoholic Steatohepatitis Study(NASH) sponsored by the National Institutes of Health (NIH)

Liver Transplantation in HIV+ Children sponsored by the National Institutes of Health (NIH) National Institute Allergy and Infectious Disease

Immunosuppression Withdrawal for Pediatric Living-donor Liver Transplant Recipients with the Department of Health and Human Service

Closed Studies

Interferon +/- Ribavirin for Children with HCV (PEDS-C) sponsored by the National Institutes of Health (NIH) / National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) – CLOSED to enrollment

SPLIT--Studies of Pediatric Liver Transplantation, (is a multi-center, prospective study to collect scientific data in pediatric liver transplantation) sponsored by the NIH- CLOSED to enrollment

Pegylated Interferon +/- Ribavirin for Children with HCV (PEDS-C) sponsored by the National Institutes of Health (NIH) / National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)- CLOSED to enrollment

SPLIT--Studies of Pediatric Liver Transplantation, (is a multi-center, prospective study to collect scientific data in pediatric liver transplantation) sponsored by the NIH- CLOSED to enrollment

FOG 1- Functional Outcomes of Liver Transplant (HRQOL) – ancillary study to SPLIT, sponsored by the NIH- CLOSED to enrollment

FOG 2- Functional Outcomes of Liver Transplant (Cognitive Development & School Performance) ancillary study to SPLIT, sponsored by the NIH- CLOSED to enrollment

TONIC-Treatment of Non-alcoholic liver disease in children - sponsored by the NIH- CLOSED to enrollment

CLIC – Longitudinal Study of Genetic Causes or Intrahepatic Cholestasis, a multi-center study investigating PFIC, BRIC, A1AT, Alagille Syndrome, and BAD, Sponsored by the NIH. -CLOSED to enrollment

CLIC-Mito – Longitudinal Study of mitochondrial Hepatopathies, sponsored by the NIH- CLOSED to enrollment

Evaluation of the Pharmacokinetic, Safety, Tolerability and Efficacy of Entecavir (ETV) in Pediatric Subjects with Chronic Hepatitis B Virus (HBV) Infection who are HBeAG-Positive; sponsored by Bristol-Myers Squibb- CLOSED to enrollment

Pediatric Acute Liver Failure Study (ALF) sponsored by the National Institutes of Health (NIH) CLOSED to enrollment

PROBE - A Prospective Database of Infants with Cholestasis conducted by the Biliary Atresia Research Consortium, sponsored by the National Institute of Diabetes, Digestive, and Kidney Diseases of the National Institutes of Health (NIH)- CLOSED to enrollment

START – A Randomized double-blinded, placebo-controlled trial of corticosteroid therapy following portoenterostomy in infants with biliary atresia (NIH)- CLOSED to enrollment

BASIC – Biliary Atresia Study in Infants and Children (NIH)- CLOSED to enrollment

For more information, please contact:

• Camille Langlois at (415) 476-1756 or via email
• Natasha Feier at (415) 476-1539 or via email

• Optimizing liver and cardiovascular health after pediatric liver transplant. This biobanking project, sponsored by UCSF Transplant Surgery, aims to identify liver biopsy findings and other biomarkers associated with long-term liver and cardiovascular health in people that had liver transplants as children (Enrolling)
• Causes and consequences of post-transplant metabolic syndrome in pediatric liver transplant recipients. This is a prospective study to investigate the contribution of obesity, corticosteroid exposure, and immunosuppression medications to the risk of developing post-transplant metabolic syndrome (PTMS) (Sponsored by NIDDK, enrolling)
• A study of post-traumatic stress symptoms (PTSS) in adolescent liver transplant recipients. This study is being done to better understand if post-traumatic stress symptoms play a role in the way adolescent transplant recipients take their prescribed medicine (Enrolling soon)
• Studies in Pediatric Liver Transplantation (SPLIT). A Multi-center observational study focused on improving a wide variety of outcomes among pediatric patients who have undergone liver transplant (Enrolling)

Please contact Dr. Emily Perito for more information ([email protected])