CLINICAL TRIALS

GRANT SUPPORT:

Principal Investigator

1. Mallinckrodt / Pharmerit - Observational Chart Review of HRS. Retrospective, observational study based on data collection from pre-existing medical records of patients hospitalized with HRS-1. Objectives is to establish the time course from diagnosis of cirrhosis, first and subsequent HRS-1 episodes, liver transplant, and death; and to describe treatment regimens and clinical outcomes during hospital admission for HRS-1.
   October 2020 - present


2. LLS-019: Evaluation of the diagnostic performance of the M30 Apoptosense, M65 and M65 EpiDeath ELISA Assay results to stratify Non-Alcoholic Steatohepatitis (NASH) from simple steatosis in a cohort of patients suspected of Non-Alcoholic Fatty Liver Diseases (NAFLD)
   June 2020 - present


3. DUR928-020: A Randomized, Double-Blind, Placebo Controlled Study to Evaluate Safety and Efficacy of DUR-928 in Subjects Infected with SARS-CoV-2 with Acute Liver or Kidney Injury
   May 2020 – present


4. Grifols APACHE: Effects of Plasma Exchange with Human Serum Albumin 5% (PE-A 5%) on Shortterm Survival in Subjects with "Acute-On-Chronic Liver Failure" (ACLF) at High Risk of Hospital Mortality – Phase 3
   February 2020- present


5. GILEAD-4194A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Efficacy of GS-9674 in Non-Cirrhotic Subjects with Primary Sclerosing Cholangitis 
   January 2020- present


6. CONATUS IDN-6556-17, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Emricasan, an Oral Caspase Inhibitor, in Subjects with Decompensated Non-Alcoholic Steatohepatitis (NASH) Cirrhosis.
   Jan 2018 - Closed


7. ICPT 747-304: A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Obeticholic Acid in Subjects with Compensated Cirrhosis due to Nonalcoholic Steatohepatitis
   April 1st 2019 – active and closed to enrollment


8. GENFIT GFT505-315-1, 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.
   September 28th 2016 – active and closed to enrollment


9. ABBVIE 2014-2020, An Open-Label, Multicenter Study to Evaluate Long-term Outcomes with ABT-450/Ritonavir/ABT-267(ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (TOPAZ II) Phase 3b. Protocol M 14-222.
   September 6th 2014 – active and closed to enrollment


10. SARO 16.004.05 A Phase 2, Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety, Tolerability and Efficacy of Saroglitazar Magnesium in Patients with Primary Biliary Cholangitis
    June 26th 2017 – October 26, 2020


11. GILEAD GS-US 384-1943 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.
    May 25th 2017 – July 24th 2019


12. GILEAD GS-US 384-1944 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).
    April 25th 2017 – July 25th 2019


13. CONATUS IDN-6556-14, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Emricasan, an Oral Caspase Inhibitor, in Subjects with Non-Alcoholic Steatohepatitis (NASH) Cirrhosis and Severe Portal Hypertension.
    October 24th 2016 – June 20th 2019


14. CONATUS IDN-6556-12, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Emricasan (IDN-6556), an Oral Caspase Inhibitor, in Subjects with Non-alcoholic Steatohepatitis (NASH) Fibrosis
    May 6th 2016 – April 11th 2019


15. CONATUS IDN-6556-17, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Emricasan, an Oral Caspase Inhibitor, in Subjects with Decompensated Non-Alcoholic Steatohepatitis (NASH) Cirrhosis.
    Jan 2018 - Closed


16. GILEAD GS-US-454-4378, A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Selonsertib, GS-0976, GS-9674, and Combinations in Subjects with Bridging Fibrosis or Compensated Cirrhosis due to Nonalcoholic Steatohepatitis
    September 14th 2018 - Closed


17. SALIX / VALEANT - RNHE2041, A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Multicenter Study to Assess the Efficacy and Safety of Rifaximin Soluble Solid Dispersion (SSD) Tablets Plus Lactulose for the Treatment of Overt Hepatic Encephalopathy (OHE)
    November 6th 2018 – closed


18. GILEAD GS-US-416-2124, 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
    October 2017– Closed


19. A Single Arm, Open-label Study to Evaluate the Efficacy and Safety of Glecaprevir (GLE)/Pibrentasvir (PIB) in Treatment Naïve Adults with Chronic Hepatitis C Virus (HCV) Genotype 1, 2, 4, 5 or 6 Infection and Compensated Cirrhosis.
    June 29th 2017 – Closed


20. MERCK 047 -00 A Phase 3 Clinical Study to Evaluate the Efficacy and Safety of the Combination Regimen of MK-3682C (Ruzasvir/Uprifosbuvir) in Participants with Chronic Hepatitis C Virus Genotype 1 or 4 Infection.
    June 26th 2017 – Closed


21. A Phase 3 Clinical Study to Evaluate the Efficacy and Safety of the Combination Regimen of MK-3682B (Grazoprevir/Ruzasvir/Uprifosbuvir) in Participants with Chronic Hepatitis C Virus Genotype 3 Infection.
    June 26th 2017 – Closed


22. CONFIRM MNK19013058, A Multi-Center, Randomized, Placebo-Controlled, Double-Blind Study To Confirm Efficacy And Safety Of Terlipressin In Subjects With Hepatorenal Syndrome Type 1.
    May 12th 2017 – closed


23. PROMETHEUS 16HEP01, Procurement of Blood Samples from Subjects with Diagnosed Nonalcoholic Steatohepatitis (NASH) or Nonalcoholic Fatty Liver Disease (NAFLD) for Use in the Development of a Liver Fibrosis Test
    October 1st 2017 – Closed


24. SHIRE NASH SHP626-201, 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.
    October 24th 2016 – Closed


25. GILEAD, FOCUS Award to support HIV and/or Hepatitis C tested and testing related services.
    December 16th 2016 - Closed


26. GILEAD GS-US-426-3989, A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Efficacy of GS-0976 in Subjects with Nonalcoholic Steatohepatitis.
    October 3rd 2016 – Closed


27. MERCK MK-3682-021, A Phase II, Randomized, Open-Label Clinical Trial to Study the Efficacy and Safety of the Combination Regimen MK-3682B (MK-5172+MK-3682+MK-8408 Fixed dose combination) in Subjects with Chronic HCV GT1 or GT3 infection who have failed a Direct Acting Antiviral Regimen.
    January 21st, 2016 – Closed


28. International Club of Ascites: Study Epidemiology and clinical impact of bacterial infections in hospitalized patients with cirrhosis: A multicenter observational prospective survey among the members of the international club of Ascites.
    September 6th 2015 – Closed


29. MERCK MK-3682-012, A Phase II study to evaluation the Efficacy and Safety of the Combination Regimen of MK-5172 and MK-2248 with either MK-8742 or MK-8408 in cirrhotic or non-cirrhotic Hepatitis C virus subjects with chronic HCV genotype (GT) 3 infection. Protocol Number:
    December 12th 2015 – June 6th 2017


30. VTI-308, A Randomized, Open-label, Multicenter, Controlled Study to Assess Safety and Efficacy of ELAD® in Subjects with Severe Acute Alcoholic Hepatitis (sAAH) and Lille Score Failure who have Failed Steroid Therapy.
    November 30th, 2015 – Closed


31. MERCK MK-3682-011, A Phase II, Randomized, Open-Label Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172 and MK-3682 with Either MK-8742 or MK-8408 in Subjects with Chronic HCV GT1, GT2, and GT4 Infection.
    October 21st 2015 – February 17th 2017


32. CONATUS IDN-6556-07, A Multicenter, Double Blind, Sponsor-Open Trial of IDN-6556 in Subject Who had Hepatitis C Virus (HCV) Reinfection and Liver Fibrosis Following Orthotropic Liver Transplantation for Chronic HCV Infection and Who Subsequently Achieved a Sustained Virologic Response Following anti-HCV Therapy.
    March 25th 2015 June 6th 2016
    October 15th 2014 – September 18th 2015


33. VTI-212, An Open-Label, Multicenter, Historically-Controlled Study To Assess Safety And Efficacy of ELAD® in Subjects with Acute Liver Failure (ALF).Protocol Number: VTI-212
    February 18th 2015 – September 1st 2015


34. MERCK MK-3682-017, 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.
    February 2015- June 6th 2017


35. Mobilization of Stem Cells with G-CSF and Mozobil in Patients with Cirrhosis - A Phase I Study G-CSF-Mozobil Study.
    February 19 2015 – December 9th 2015


36. VTI-208, A Randomized, Open-Label, Multicenter, Controlled Study to Assess Safety and Efficacy of ELAD® in Subjects with Alcohol-Induced Liver Decompensation (AILD) Protocol No: VTI-208..
    January 20th, 2015 – September 1st 2015\


37. DUKE RESEARCH INSTITUTE HBV APTIMA ASSAY, Collection of Plasma Samples From Individuals Initiating Therapy With Entecavir or Tenofovir for Chronic Hepatitis B Virus Infection for the Clinical Evaluation of the Aptima HBV Quant Assay: V10434-HBVQPS-CSP.
    December 2nd, 2014 – April 6th 2016


38. CONATUS IDN-6556-11, A Multicenter, Double-Blind, Placebo Controlled Study to Evaluate the Safety, Tolerability and Efficacy of IDN-6556 in Subjects with Liver Cirrhosis and Portal Hypertension (Conatus SCLRC - CTN 6556-11)
    October 15th 2014 – September 18th 2015


39. CONATUS IDN 6556-10, A Multicenter, Double-Blind, Placebo Controlled Study to Evaluate the Safety, Tolerability and Efficacy of IDN-6566 in Subjects with Liver Cirrhosis (Conatus) SCLRC - CTN 6556-10.
    September 15th 2014 – June 15th 2015


40. TOPAZ II Protocol M 14-222 An Open-Label, Multicenter Study to Evaluate Long-term Outcomes with ABT-450/Ritonavir/ABT-267(ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection Phase 3b. Protocol M 14-222
    September 6th 2014 – Closed


41. ROCHE, Collection of Blood Specimens from Subjects Infected with Chronic Hepatitis C (Genotypes 2 and 3) and Treated with Sofosbuvir plus Ribavarin ("Research Study) Protocol #COL-HCV-343.
    August 19th, 2014 –October 18th, 2016


42. HBV DUKE, Collection of Plasma and Serum Samples from Individuals Initiating Therapy with Sofosbuvir for Chronic Hepatitis C Virus Infection for the Clinical Evaluation of the Aptima HCV Quantitative Diagnosis Assay.
    August 19th 2014 – April 30th 2017


43. OCERA, Multicenter, Randomized Phase 2B Study to Evaluate the Efficacy, Safety and Tolerability of OCR-002 (ornithine phenyl acetate) in Hospitalized Patients with Cirrhosis and Associated Hyperammonaemia with an Episode of Hepatic Encephalopathy STOP-HE Study.
    August 15 2014 – March 24 2017


44. Randomized, Double-Blind, Double-Dummy, Placebo-Controlled Parallel Group Multicenter Study to Evaluate the Clinical Equivalence of Lubiprostone 24 meg Capsules w/AMJTIZA (Lubiprostone) 24 meg capsules in the Treatment of Chronic Idiopathic Constipation Parexel
    August 14th 2014 – March 25th 2015


45. SALIX RNLC 2131, A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging,    Multicenter Study To Assess The Efficacy And Safety Of Rifaximin Soluble Solid Dispersion (Ssd) Tablets For The Prevention Of Complications In Subjects With Early Decompensated Liver Cirrhosis.
    May 20th 2014 – September 23rd 2015


46. AI444-058, Comparative Assessment of Effectiveness of Antiviral Therapies in Hepatitis C (COMPASS)
    2013-2014 


47. AI444-046 A Long-Term Follow-up Study of Subjects Who Participated in A Clinical Trial in Which BMS-650032 and/or BMS 790052 Was Administered for the Treatment of Chronic Hepatitis C.
    2012-2014


48. AI444-038 Bristol-Myers Squibb, Open-Label, Single Arm Evaluation of BMS-790052 in Combination with Peg-Interferon Alfa-2a and Ribavirin in Black-African Americans, Latinos, and White-Caucasians with Chronic Hepatitis C Genotype 1 Infection. Phase 3.
    2011- 2013


49. ONC 2010-19 Univ. FL/Bayer, Multicenter, Randomized Pilot Study of the Effect of Sorafenib Dosing Schedule on Tolerability and Drug Delivery.
    2011- 2013. 


50. GS-US-196-0140 Gilead, A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating 16 and 24 weeks of a Four-Drug Regimen and 24 Weeks of a Three-Drug Regimen of GS-9451, Peginterferon Alfa 2a (PEG, Pegays®) and Ribavirin (RBV, Copegus®) With and Without Tegobuvir (GS-9190) Followed by Response Guided PEG and RBV in Treatment Naïve Subjects with Chronic Genotype 1 Hepatitis C Virus Infection (Protocol GS-US-196-0140).
    2010-2013.


51. A4061058 Pfizer, A Multicenter, Global, Randomized, Double-Blind Study of Axitinib Plus Best Supportive Care Versus Placebo Plus Best Supportive Care in Patients With Advanced Hepatocellular Carcinoma Following Failure of One Prior Antiangiogenic Thereapy. Phase 2.
    2010-2013.


52. NV22776 Roche, A Randomized, Open label, Multicenter, Dose and Duration Finding Study to Evaluate the Sustained Virologic Response of the HCV Protease Inhibitor Danoprevir Boosted with Low Dose Ritonavir (danoprevir/r) in Combination with Pegasys® and Copegus® versus Pegasys® and Copegus® alone in Treatment-Naive Patients with Chronic Hepatitis C Genotype 1 or 4 Virus Infection. Phase 2b.
    2010-2013


53. BMS AI444-016 Bristol-Myers Squibb, A Phase 2a/2b study of BMS-650032 in Combination With Peginterferon Alfa-2a ) Pegasys) and Ribavirin (Copegus) in Treatment-Naïve subjects with Genotypes 1 and 4 Chronic Hepatitis C Infection.
    2010-2012


54. DEB025A2210 Novartis, A multicentre, randomized, double-blind, placebo-controlled, parallel- group phase II study on the efficacy and safety of DEB025 combined with peg-IFN alfa-2a and ribavirin in chronic hepatitis C genotype 1 patients who are previous peg-IFN alfa-2a plus ribavirin treatment non-responders.
    2010-2011


55. BAYER 12918 Bayer, SPACE study, A Phase II Randomized, Double-Blind, Placebo- Controlled Study of Sorafenib or Placebo in Combination with Transarterial Chemoembolization(TACE) Performed with DC Bead and Doxorubicin for Intermediate Stage Hepatocellular Carcinoma (HCC)
    2009-2012


56. EFC6682 Sanofi Aventis, Satavaptan Cirrhotic Ascites Treatment Study: a double-blind, randomized, parallel group comparison of treatment with satavaptan at 5 to 10 mg daily versus placebo in the absence of diuretics in patients with recurrent ascites due to cirrhosis of the liver. Sanofi Aventis, Phase III  2009-2012
    2008-2009


57. PROTECT - Pegylated Interferon alfa-2b and Ribavirin After Orthotopic Liver Transplantation: Efficacy in Hepatitis C Recurrence Therapy (University of Miami).
    2006- 2007


58. A Phase 2b Randomized , Double-Blind, Placebo-Controlled Study Evaluating the Safety And Efficacy OF BMS-986036 (PEG-FGF21) in Adults with Nonalcoholic Steatohepatitis (NASH) and Compensated Liver Cirrhosis

Investigator Initiated

Analysis of Immunosuppressive Regimen in Pre- and Post- Liver Transplant Patients with COVID-19

Clinical Outcome of Hospitalized Liver Disease Patients with COVID-19