Diseases

• Quality Improvement Initiative called Improve Care Now (ICN) in Inflammatory Bowel Disease (IBD) sponsored by UCSF Medical Center (now enrolling)
• Takeda MLN0002-2003: A Phase 2, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Safety and Tolerability of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease (enrolling soon)
• ADAPT: 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 (IBD) sponsored by Janssen Pharmaceuticals (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, now enrolling UC and IC patients <17 years of age who have been exposed to Remicade)

• A Phase III, Randomized, Double Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Etrolizumab as an Induction and Maintenance Treatment for Adult Patients with Moderately to Severely Active Crohn’s Disease (CD) sponsored by Genentech (now enrolling)
• CAPE: 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) sponsored by AbbVie (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 Refractory to or Intolerant of TNF Inhibitors 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 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)
• 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 B sponsored by Janssen Pharmaceuticals (patients in follow-up, no longer enrolling)

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 Randomized, Double-Blind Evaluation of the Pharmacokinetics, Safety, and Antiviral Efficacy of Tenofovir Alafenamide (TAF) in Adolescents with Chronic Hepatitis B Virus 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

A Phase 2, Open-Label, Multicenter, Multi-cohort Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir in Adolescents and Children with Chronic HCV Infection (GS 1143)-Sponsored by Gilead Sciences, Inc.

An Open-Label, Multicenter Study to Evaluate the Pharmacokinetics, Safety, and Efficacy of Glecaprevir/Pibrentasvir in Pediatric Subjects with Genotypes 1 – 6 Chronic Hepatitis C Virus (HCV) Infection- (M16-123) Sponsored by Abbvie

• Metabolic/genetic liver diseases
• Mitochondrial liver diseases
• Fontan-associated liver disease