Barnes, Maisha. Habib, Adil. Kedia, Prashant

Transcription

1 Study Title PI Area of Discipline A Phase 2, Randomized, Double-Blind, Placebo-Controlled, 12-Month, Multiple-Dose Study to Evaluate the Safety, Tolerability and Efficacy of Three Dose Levels of MSDC- 0602K in Patients with NASH (EMMINENCE ) A Phase 2 Double-Blind, Randomized, Placebo-controlled, Dose-finding Study to Evaluate the Safety, Tolerability and Efficacy of Volixibat Potassium, an Apical Sodium- Dependent Bile Acid Transporter Inhibitor (ASBTi) in Adults with Nonalcoholic Steatohepatitis (NASH) Radio Frequency ablation in the management of Pancreatico-biliary disorders: A Multicenter Registry Endoscopic Sutures for Gastrointestinal Tract Disorders: A Prospective Multicenter Registry Peroral Endoscopic Myotomy (POEM) for the treatment of Achalasia: A Retrospective and Prospective Multicenter Registry Endoscopic Ultrasound (EUS) - Guided Endoscopic retrograde cholangiopancreatography (ERCP) in the management of Pancreatic-Biliary disorders. A Multicenter Registry Barnes, Maisha Habib, Adil Efficacy, safety, and adequacy of EUS-guided liver biopsy Endoscopic Gallbladder Drainage Evaluation of safety and efficacy of NvisionVLE Imaging Low Profile system in patients with bile duct disease A Phase 3, Double-Blind, Randomized, Long-Term, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of Obeticholic Acid in Subjects with Nonalcoholic Steatohepatitis Phase 3b, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Effect of Obeticholic Acid on Clinical Outcomes in Subjects with Primary Biliary Cirrhosis Active and Trials Page 1 of 5

2 A Phase II, Randomized, Open-Label Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172, MK-3682 and MK-8408 in Subjects with Chronic HCV GT1 or GT3 Infection who have failed an All Oral Direct Acting Antiviral Regimen A Randomized, Open-Label, Multicenter, Controlled Study to Assess Safety and Efficacy of ELAD in Subjects with Alcohol-Induced Liver Decompensation (AILD) VTI 208 A Humanitarian Device Exemption Treatment Protocol of TheraSphere for Treatment of Unresectable Primary or Unresectable Secondary Liver Cancer A Long-Term Follow-up Study to Evaluate the Durability of Virologic Response and/or Viral Resistance Patterns of Subjects With Chronic Hepatitis C Who Have Been Previously Treated with MK-5172 in a Prior Clinical Trial A Long Term Follow-up Registry for Subjects Who Achieve a Sustained Virologic Response to Treatment in Gilead-Sponsored Trials in Subjects with Chronic Hepatitis C Infection A Registry for Subjects with Cirrhosis Who Achieve a Sustained Virologic Response Following Treatment with a Sofosbuvir-Based Regimen without Interferon for Chronic Hepatitis C Infection Phase 2, Open-Label, Clinical Trial of Miravirsen Sodium in Combination with Telaprevir and Ribavirin in Null Responders to Pegylated Interferon Alpha plus Ribavirin Subjects with Chronic Hepatitis C Virus Genotype 1 Infection Open-label, Phase 2 Study to Evaluate the Safety and Efficacy of the Combination of ABT-450/ritonavir/ABT-267 (ABT450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adult Transplant Recipients with Genotype 1 Hepatitis C Virus (HCV) Infection (CORAL-I) Follow-Up Registry to A Randomized, Open-Label, Multicenter, controlled study to Assess safety and Efficacy of ELAD in Subjects with Alcohol-Induced Liver Decompensation (AD) A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Efficacy of GS-0976 in Subjects with Nonalcoholic Steatohepatitis Active and Trials Page 2 of 5

3 A Phase 2, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Safety, Tolerability, and Efficacy of GS-9674 in Subjects with Primary Sclerosing Cholangitis Without Cirrhosis A PHASE 2, PILOT STUDY OF JKB-122 TO ASSESS VER TESTS (ALT) IN AUTOIMMUNE HEPATITIS PATIENTS WHO ARE REFRACTORY OR INTOLERANT TO CURRENT THERAPIES A Single-Arm, Open-Label, Multicenter Study to Evaluate the Safety and Efficacy of ABT-493/ABT-530 in Adult Post-Liver or Post-Renal Transplant Recipients with Chronic Hepatitis C Virus Genotype 1 6 Infection (MAGELLAN-2) A Phase 2, Double-Blind, Randomized Study Evaluating the Safety, Tolerability, and Efficacy of GS-4997 in Combination with Prednisolone versus Prednisolone Alone in Subjects with Severe Alcoholic Hepatitis (AH) A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Efficacy of GS-9674 in Subjects with Nonalcoholic Steatohepatitis (NASH) A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of Elafibranor in Patients with Nonalcoholic Steatohepatitis (NASH) and fibrosis A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Selonsertib in Subjects with Compensated Cirrhosis due to Nonalcoholic Steatohepatitis (NASH) Sample Collection "Elecsys Sirolimus and Elecsys Everolimus" Long Term Success Rates and Complications Of Metallic And Plastic Stents In Post- Transplant Bile Duct Strictures: A Large Single Center Experience Protocol for Tracking Economic Data of Subjects Participating in Protocol VTI-208 A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Emricasan, an Oral Caspase Inhibitor, in Subjects with Decompensated Non-Alcoholic Steatohepatitis (NASH) Cirrhosis Active and Trials Page 3 of 5

4 A Phase 2, Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination and Ribavirin for 12 Weeks in Subjects with Chronic HCV Infection and Child-Pugh-Turcotte Class C Cirrhosis A Long-Term Follow-up Study of Subjects Who Participated in a Clinical Trial in Which Asunaprevir (BMS ) and/or Daclatasvir (BMS ) Was Administered for the Treatment of Chronic Hepatitis C A Phase 3 Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-3682B (Grazoprevir/Ruzasvir/Uprifosbuvir) in Participants with Chronic Hepatitis C Virus Genotype 3 Infection Evaluation of Patient Preferences for Shared Decision Making and Patient-Centered Care Determining the efficacy of a single regimen of Sofosbuvir + Velpatasavir in chronic hepatitis C genotype 2 & 3 patients who have failed previous treatment with directly acting antivirals Sofosbuvir-based regimens in Hepatitis C genotype 1-patients with End-Stage Renal Disease on hemodialysis or GFR <30mL/min Efficacy of a Single Tablet Regimen of Sofosbuvir + Velpatasavir with Ribavirin in Chronic Hepatitis C Genotype 3 Patients with compensated cirrhosis who have failed previous treatment A randomized, double-blind, placebo controlled, 2- part, adaptive design, multicenter 12-week study to assess safety, tolerability and efficacy of LJN452 in patients with non-alcoholic steatohepatitis (NASH) The prevalence of radiographic changes consistent with fatty liver in patients with ESRD on wait list for kidney transplant A Phase 2, Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Ledipasvir/Sofosbuvir in Subjects with Genotype 1, 4, 5 and 6 Chronic HCV Infection Who are on Dialysis for End Stage Renal Disease Active and Trials Page 4 of 5

5 A Phase 2, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Safety, Tolerability, and Efficacy of GS-9674 in Subjects with Primary Biliary Cholangitis Without Cirrhosis A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Selonsertib in Subjects with Nonalcoholic Steatohepatitis (NASH) and Bridging (F3) Fibrosis A randomized, double-blind, multi-dose, placebo-controlled study to evaluate the efficacy, safety and tolerability of GSK administration for the treatment of pruritus in patients with primary biliary cholangitis. (GMMER: GSK trial of Ibat inhibition with Multidose Measurement for Evaluation of Response). Dallas Acute Pancreatitis Protocol (DAPP) Registry Trial to Determine pcle Image Interpretation Criteria and Preliminary Accuracy for Primary Sclerosing Cholangitis Biliary Clinical Investigation to Evaluate Removal of the Evolution Esophageal Stent Fully Covered A PHASE 1, SINGLE DOSE PK AND SAFETY STUDY WITH NI-03 FOLLOWED BY A PHASE 2, RANDOMIZED, DOUBLE-BND, PARALLEL-GROUP DOSE-RANGING STUDY TO EVALUATE THE SAFETY AND EFFICACY OF NI-03 COMPARED TO PLACEBO IN SUBJECTS WITH CHRONIC PANCREATITIS Rectal Indomethacin in the Prevention of Post- ERCP Pancreatitis in High Risk Patients: Searching for the Optimal Dose. A prospective, Randomized Trial A Prospective Multi-Center Registry using Plastic Pancreatic Stents for Short-Term Drainage of the Pancreatic Duct A Registry/Observational Study of Patients Undergoing ERCP and Possible Sphincterotomy for Post-Cholecystectomy Pain Fully Covered Self Expanding Metal Stents (FCSEMS) for Pancreatic Duct Strictures in Patients with Chronic Pancreatitis Development of Acute Pancreatitis Quality Indicators Active and Trials Page 5 of 5