Trial Contact

Research Coordinator: Grace Kim Lee
GraceKim.Lee@uphs.upenn.edu

Studies

MS AI444-257 

A Multicenter Treatment Protocol of Daclatasvir (BMS-790052) in Combination with Sofosbuvir for the Treatment of Subjects with Chronic Hepatitis C and Decompensated Cirrhosis or Post-Liver Transplant Subjects with Chronic Hepatitis C Recurrence.

Conatus IDN-6556-07

A Multicenter, Double-Blind, Sponsor-Open Trial of IDN-6556 in Subjects Who had Hepatitis C Virus (HCV) Reinfection and Liver Fibrosis following Orthotopic Liver Transplantation for Chronic HCV Infection and Who Subsequently Achieved a Sustained Virologic Response Following anti-HCV Therapy.

EDRN

Hepatocellular Carcinoma Early Detection Strategy study.

Galectin GT-026

A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Phase two Clinical Trial to Evaluate the Safety and Efficacy of GR-MD-02 for the Treatment of Liver Fibrosis and Resultant Portal Hypertension in Patients with NASH Cirrhosis.

Intercept 727-207

A Phase II, Randomized, Double-Blind, Placebo-Controlled, Dose-Finding, Clinical Trial Evaluating the Efficacy and Safety of Obeticholic Acid in Subjects with Primary Sclerosing Cholangitis.

Intercept 727-302

A Phase IIIb, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Effect of Obeticholic Acid on Clinical Outcomes in Subjects with Primary Biliary Cirrhosis.

Ocera OCR002-H209

A Multicenter, Randomized Phase IIB Study to Evaluate the Efficacy, Safety and Tolerability of OCR-002 (ornithine phenylacetate) in Hospitalized Patients with Cirrhosis and Associated Hyperammonemia with an Episode of Hepatic Encephalopathy

Abbvie M14-227

An Open-Label Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir with Ribavirin in Adults with Genotype I and Ombitasvir/Paritaprevir/Ritonavir with Ribavirin in Adults with Genotype 4 Chronic Hepatitis C Virus

Infection and Decompensated Cirrhosis (TURQUOISE-CPB)

A Multi-Center Group to Study Acute Liver Failure (ALF)  -- ENROLLING

STOP-ALF

A Phase IIa Study to Evaluate the Safety and Tolerability of OCR-002 (ornithine phenylacetate) in the treatment of patients with Acute Liver Failure/Severe Acute Liver Injury (STOP-ALF) – ENROLLING

M14-226

An Open-Label Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir with or without Ribavirin (RBV) in Adults with Genotype I Chronic Hepatitis C Virus (HCV) Infection, with Severe Renal Impairment or End-Stage Renal Disease (RUBY-1) - ENROLLING

M14-726 

An Open-Label Study to Evaluate the Safety and Efficacy of the Combination of Ombitasvir/ Paritaprevir/r ± Dasabuvir with Ribavirin (RBV) in Adult Patients with GT1 or GT4 Chronic HCV Infection and Response to Prior Treatment of Early Stage Hepatocellular Carcinoma – ENROLLING

GS-384-1497

A Phase II, Randomized, Open Label Study Evaluating the Safety, Tolerability, and Efficacy of GS-4997 alone or in Combination with Simtuzumab (SIM) in Subjects with Nonalcoholic Steatohepatitis (NASH) and Fibrosis Stages F2-F3 – ENROLLING

BMS MB130-068

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 stage 3 liver fibrosis

Contact: Sarah.Dwyer@pennmedicine.upenn.edu  215-349-2563

 

Intercept 747-304

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

Contact: Kaylin.Lemelle-Thomas@pennmedicine.upenn.edu   215-349-8507

 

Intercept 747-303

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

Contact: Kaylin.Lemelle-Thomas@pennmedicine.upenn.edu   215-349-8507

 

Intercept 747-302

A phase 4, double-blind, randomized, placebo-controlled, multicenter study evaluating the effect of obeticholic acid on clinical outcomes in subjects with primary biliary cholangitis

Contact: Kaylin.Lemelle-Thomas@pennmedicine.upenn.edu   215-349-8507

 

Zydus

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

Contact: Gracekim.lee@pennmedicine.upenn.edu   215-360-0836

 

SHIP

A randomized, placebo-controlled pilot study of sulfasalazine for the treatment of Primary Sclerosing Cholangitis

Contact: Alexandra.Reilly@pennmedicine.upenn.edu  215-360-0948

 

HepQuant

The HepQuant SHUNT Liver Diagnostic Kit for Likelihood of Large Esphageal Varices: The SHUNT-V Study

Contact: Emily.Toal@pennmedicine.upenn.edu   215-349-8548

 

GRIFOLS APACHE- APHERESIS+ ALBUMIN FOR DECOMPENSATED CIRRHOSIS

Prevention of Mortality with Long-Term Administration of Human Albumin in subjects with decompensated Cirrhosis and Ascites.

Contact: Sarah.Dwyer@pennmedicine.upenn.edu  215-349-2563

 

GRIFOLS APACHE-APHERESIS+ALBUMIN FOR ACLF

Effects of Plasma Exchange with Human Serum Albumin 5% (PE-A 5%) on Short term survival in subjects with ‘Acute-On-Chronic Liver Failure” (ACLF) at High Risk of Hospital Mortality.

Contact: Sarah.Dwyer@pennmedicine.upenn.edu  215-349-2563

 

VALEANT/SALIX- RIFAXIMIN SSD+ LACTULOSE FOR OHE

A randomized, double-blind, placebo-controlled, dose-ranging, multicenter study to assess the efficacy and safety of rifaximin soluble dispersion (SSD) tablets plus lactulose for the treatment of overt hepatic encephalopathy (OHE)

Contact: Sarah.Dwyer@pennmedicine.upenn.edu  215-349-2563

 

ACCLIMATE

Gut Microbiota-Targeted Assessment and Treatment of Acute-On-Chronic Liver Failure

Contact: Kaylin.Lemelle-Thomas@pennmedicine.upenn.edu  215-349-8507 or Emily.Toal@pennmedicine.upenn.edu   215-349-8548

 

A single-center, open label, cross-over study on the effects of ursodeoxycholic acid (UDCA) in patients with hepatic sarcoidosis.

Contact: Emily.Toal@pennmedicine.upenn.edu    215-349-8548

 

TARGET-HCC

A 5-year longitudinal observational study of the natural history and management of patients with Hepotocellular Carcinoma.

Contact: Alexandra.Reilly@pennmedicine.upenn.edu   215-360-0948

 

TARGET-NASH

A 5-year longitudinal observational study of patients with nonalcoholic fatty liver or nonalcoholic steatohepatitis.

Contact: Alexandra.Reilly@pennmedicine.upenn.edu   215-360-0948

 

TARGET-PBC

A 5-year longitudinal observational study of patients with primary biliary cholangitis.

Contact: Alexandra.Reilly@pennmedicine.upenn.edu   215-360-0948

 

Trio Health Retrospective and Prospective Observational Study

Real world utilization of oral antivirals for HBV in clinical practice

Contact: Sarah.Dwyer@pennmedicine.upenn.edu   215-349-8548

 

Gilead 337-1431

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.

Contact: Emily.Toal@pennmedicine.upenn.edu   215-349-8548

 

Early Detection Research Network (EDRN) Hepatocellular Carcinoma Early Detection Strategy

Contact: Alexandra.Reilly@pennmedicine.upenn.edu   215-360-0948

 

HEPATIC ADENOMA

Hepatic Adenomas: Building a biorepository to examine genetic and environmental contributions to disease (multi-center).

Contact: Emily.Toal@pennmedicine.upenn.edu   215-349-8548

 

EXACT SCIENCES

Blood sample collection to evaluate biomarkers for hepatocellular carcinoma.

Contact: Alexandra.Reilly@pennmedicine.upenn.edu  215-360-0948

 

LAM-2018-01

Prospective clinical trial to detect liver cancer through quantification of cfDNA Methylation in Blood Samples (CLiMB)

Contact: Alexandra.Reilly@pennmedicine.upenn.edu  215-360-0948

 

GRACE

Dissecting the genetic and environmental contributions of autoimmune liver disease: Genetic Respiratory of Autoimmune liver disease and Contributing Exposures (GRACE).

Contact: Emily.Toal@pennmedicine.upenn.edu   215-349-8548

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