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  3. Liver

Liver

Recruiting

Safety, Tolerability, and Efficacy of GS-9674 in Adults With Primary Sclerosing Cholangitis Without Cirrhosis (PSC-Phase 2)

The primary objective of this study is to evaluate the safety and tolerability of GS-9674 in adults with primary sclerosing cholangitis (PSC).

Status
Recruiting
Principal Investigator
Eric Yoshida
Body Locations and Systems
Liver Diseases
Area
Vancouver
Age
18-70 years

Safety, Tolerability, and Efficacy of GS 9674 in Adults With Primary Biliary Cholangitis Without Cirrhosis (PBC-Phase 2

The primary objective of this study is to evaluate the safety and tolerability of GS-9674 in adults with primary biliary cholangitis (PBC).

Status
Recruiting
Principal Investigator
Eric Yoshida
Body Locations and Systems
Liver Diseases
Area
Vancouver
Age
18-70 years

Sofosbuvir/Velpatasvir in Adults With Chronic Hepatitis C Virus Infection Who Are on Dialysis for End Stage Renal Disease (SOF/VEL ESRD)

The primary objectives of this study are to evaluate safety, efficacy and tolerability of treatment with sofosbuvir (Sovaldi®)/velpatasvir (Epclusa®; SOF/VEL) for 12 weeks in adults with chronic hepatitis C virus (HCV) infection who are on dialysis for End Stage Renal Disease (ESRD).

Status
Recruiting
Principal Investigator
Eric Yoshida
Body Locations and Systems
Hepatitis C
Area
Vancouver
Age
18 years and above

Randomized Global Phase 3 Study to Evaluate the Impact on NASH With Fibrosis of Obeticholic Acid Treatment (REGENERATE)

The primary objectives of this study are to evaluate the effect of Obeticholic Acid treatment compared to placebo on 1) histological improvement and 2) liver-related clinical outcomes in patients with non-cirrhotic nonalcoholic steatohepatitis (NASH) with liver fibrosis.

Status
Recruiting
Principal Investigator
Eric Yoshida
Body Locations and Systems
Liver Diseases
Area
Vancouver
Age
18-85

A Study Evaluating the Safety, Pharmacokinetics, and Antiviral Efficacy of SB 9200 in Subjects Infected With Chronic HBV (ACHEIVE)

This is a Phase 2, open-label,randomized, multiple dose, varied administration regimen study with 2 parts (Parts A and B) in Subjects Infected with Chronic Hepatitis B Virus

Status
Recruiting
Principal Investigator
Eric Yoshida
Body Locations and Systems
Hepatitis B
Area
Vancouver
Age
18-70

Durability of Virologic Response and/or Viral Resistance Patterns in Participants With Chronic Hepatitis C Who Have Been Previously Treated With Grazoprevir (MK-5172) (MK-5172-017)

This three-year study (participants with chronic kidney disease [CKD] or cirrhosis will be followed for five years) multicenter study is being done to follow participants who received at least one dose of grazoprevir (MK-5172) in a previous study to determine if they remain hepatitis C virus (HCV)-RNA negative over time, and to determine if they have developed antiviral resistance. The study will also evaluate long-term adverse events in this population.

Status
Recruiting
Principal Investigator
Eric Yoshida
Body Locations and Systems
Hepatitis C
Area
Vancouver
Age
18 and above

Collection of Samples for the Clinical Evaluation of the Aptima HBV (Hepatitis B Virus) Quant (Quantification) Assay (HBVQuant)

This non-interventional clinical study will be conducted to prospectively collect serial plasma samples from subjects with chronic HBV infection who are initiating antiviral therapy. These samples will be used to estimate clinical utility endpoints for the Aptima HBV Quant assay, which is used as an aid in the management of HBV-infected patients undergoing HBV antiviral therapy.

Status
Recruiting
Principal Investigator
Peter W.C. Kwan
Body Locations and Systems
Hepatitis B
Area
Vancouver
Age
18 and above

Gilead Sustained Virologic Response (SVR) Registry

This Registry is designed to provide long term clinical and virologic follow up in subjects who have achieved sustained virologic response (SVR) while participating in a previous Gilead sponsored Hepatitis C Virus (HCV) study. This long term follow up study is observational and no treatment is provided for HCV.

Status
Recruiting
Principal Investigator
Eric Yoshida
Body Locations and Systems
Hepatitis C
Area
Vancouver
Age
18 and above

Closed for Recruitment

Phase 3 Study to Evaluate the Efficacy and Safety of Elafibranor Versus Placebo in Patients With Nonalcoholic Steatohepatitis (NASH) (RESOLVE-IT)

The primary objectives of this study are to evaluate the effect of Elafibranor treatment compared to placebo on 1) histological improvement and 2) all-cause mortality and liver-related outcomes in patients with nonalcoholic steatohepatitis (NASH) and fibrosis.

Status
Closed for Recruitment
Principal Investigator
Eric Yoshida
Body Locations and Systems
Liver Diseases
Area
Vancouver
Age
18-75

Study of Pembrolizumab (MK-3475) as Monotherapy in Adults With Previously Systemically Treated Advanced Hepatocellular Carcinoma (MK-3475-224/KEYNOTE-224)

This is a efficacy and safety study of pembrolizumab (MK-3475, KEYTRUDA®) as monotherapy in participants with previously systemically treated hepatocellular carcinoma (HCC). Study participants may receive pembrolizumab once every 3 weeks for up to 35 administrations (up to approximately 2 years).

The primary objective of this study is to determine the Objective Response Rate (ORR) of pembrolizumab given as monotherapy in participants with previously systemically treated HCC. 

Status
Closed for Recruitment
Principal Investigator
Eric Yoshida
Body Locations and Systems
Cancer
Area
Vancouver
Age
18 and above

Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C in Canada (AMBER)

This study seeks to provide evidence of the effectiveness and obtain patient reported outcome (PRO) data for the interferon-free ABBVIE REGIMEN ± RBV in participants with chronic hepatitis C (CHC) in a real life setting across clinical practice patient populations in Canada.
 

Status
Closed for Recruitment
Principal Investigator
Eric Yoshida
Body Locations and Systems
Hepatitis C
Area
Vancouver
Age
18-99

Efficacy Evaluation of TheraSphere in Patients With Inoperable Liver Cancer (STOP-HCC)

The safety and effectiveness of TheraSphere will be evaluated in patients with unresectable hepatocellular carcinoma in whom treatment with standard-of-care sorafenib is planned. All patients receive the standard-of-care sorafenib with or without the addition of TheraSphere.


 

Status
Closed for Recruitment
Principal Investigator
David Ming-Teh Liu
Body Locations and Systems
Liver
Area
Vancouver
Age
18 and above

Study of Tivantinib in Subjects With Inoperable Hepatocellular Carcinoma Who Have Been Treated With One Prior Therapy (METIV-HCC)

The purpose of this study is to determine if tivantinib (ARQ 197) is effective in treating patients with MET diagnostic-high hepatocellular carcinoma (liver cancer) who have already been treated once with another therapy.

Status
Closed for Recruitment
Principal Investigator
Alan Weiss
Body Locations and Systems
Cancer
Hepatitis C
Area
Vancouver
Age
18 and above

A Gilead Sequence Registry of Subjects Who Did Not Achieve Sustained Virologic Response

This Registry is designed to obtain long term data on participants who have failed to achieve sustained virologic response (SVR) while receiving at least one Gilead oral antiviral agent (OAV) in a previous Gilead-sponsored hepatitis C virus (HCV) study.

Status
Closed for Recruitment
Principal Investigator
Eric Yoshida
Body Locations and Systems
Hepatitis C
Area
Vancouver
Age
18 and above

Tenofovir Alafenamide Versus Tenofovir Disoproxil Fumarate for Treatment of Hepatitis B e Antigen-Positive Hepatitis B

The purpose of this study is to evaluate the safety and efficacy of tenofovir alafenamide (TAF) compared to that of tenofovir disoproxil fumarate (TDF) in treatment naive and experienced adult subjects with chronic hepatitis B virus (HBV) infection, as determined by the achievement of HBV DNA < 29 IU/mL at Week 48.

Status
Closed for Recruitment
Principal Investigator
Peter W.C. Kwan
Body Locations and Systems
Hepatitis B
Area
Vancouver
Age
18 and above

Tenofovir Alafenamide Versus Tenofovir Disoproxil Fumarate for Treatment of Hepatitis B e Antigen-Negative Hepatitis B

The purpose of this study is to evaluate the safety and efficacy of tenofovir alafenamide (TAF) compared to that of tenofovir disoproxil fumarate (TDF) in treatment naive and experienced adult subjects with chronic hepatitis B virus (HBV) infection, as determined by the achievement of HBV DNA < 29 IU/mL at Week 48.

Status
Closed for Recruitment
Principal Investigator
Peter W.C. Kwan
Body Locations and Systems
Hepatitis B
Area
Vancouver
Age
18 and above
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