Clinical Trials

The purpose of this study is to utilize liver allografts from HCV seropositive donors into 10 HCV seronegative recipients. 

The purpose of this study is to evaluate the safety and efficacy of ABT-493 and ABT-530 (or ABT-493/ABT-530) coadministered with and without ribavirin in adults with chronic HCV genotypes 2, 3, 4, 5 or 6 infection. In part 4, the primary objectives also include to assess the efficacy (SVR12) of treatment with ABT-493/ABT-530 combination regimen in GT2-infected DAA-naive subjects without cirrhosis compared to historical SVR12 rate of treatment with sofosbuvir plus RBV in GT2-infected DAA-naive subjects without cirrhosis.

This is an efficacy and safety study of grazoprevir (MK-5172) in combination with elbasvir (MK-8742) with or without ribavirin (RBV) in participants with chronic hepatitis C virus (HCV) genotype (GT) 1, 4, or 6 infections who have failed prior therapy with pegylated interferon and RBV. The primary study hypothesis is that in at least one of the study arms, the percentage of participants achieving sustained viral response 12 weeks after the end of all study treatment (SVR12) will be superior to 58%.

The purpose of this study is to determine whether INO-8000 alone or in combination with INO-9012 (IL-12) is safe and induces a Hepatitis C virus-specific immune response.

The purpose of this study, is to open expanded access at specific clinical sites at the request of an investigator for the treatment of individual subjects for whom there are no other treatment options. Patients who have an aggressive, recurring hepatitis C infection following liver transplant, will be given sofosbuvir combined with ribavirin, and pegylated interferon may or may not be added at the discretion of the investigator.

The purpose of this study is to evaluate ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in participants with chronic genotype 1 or 4 hepatitis C virus (HCV) infection. Participants will be randomized to receive 12 or 24 weeks of dosing with the LDV/SOF FDC tablet+ribavirin (RBV).

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.

The primary purpose of the HCV-TARGET study is to establish a nationwide registry of patients undergoing treatment with antiviral therapies for chronic hepatitis C (HCV) at both academic and community practices.

The purpose of this study is to compare the safety and effectiveness of using ABT-493/ABT-530, to the combination of sofosbuvir and daclatasvir in treating adults with genotype 3 chronic hepatitis C virus infection.

The purpose of this study is to:

1. To determine the prevalence of MBL in patients with chronic hepatitis C who are to begin therapy with DAA, and compare with clinic controls who are seen in the general medicine clinic at Mayo Clinic

2. To determine the correlation between the specific subtype of MBL (CD5- MBL, atypical CLL-phenotype MBL and CLL-phenotype MBL) relative to the HCV genotype

3. To assess the proportion of individuals with MBL who have an improvement in the circulating monoclonal B-cell population following therapy ...

The purpose of this study is to better understand the role of HIV and/or HCV infection and/or SARS-CoV-2 on the immune system and potential ways to eliminate the virus(es).

The purpose of this registry is to enroll patients who have cirrhosis with a sustained viral response after receiving a sofosbuvir-based treatment without interferon, either while participating in a Gilead-sponsored hepatitis C virus study or commercially at selected sites. Once enrolled, the patients will be followed for up to 5 years.

The primary purpose of the study is to establish a long-term nationwide registry of patients undergoing treatment with antiviral therapies for chronic hepatitis C  at academic and community practices.

The primary objective of this program is to provide Daclatasvir (DCV) for 24 weeks to be given in combination with Sofosbuvir (SOF) to post-liver transplant subjects with chronic hepatitis C recurrence and who have a serious or immediately life-threatening condition or experienced an event that has decreased their life expectancy to < 12 months, including advanced fibrosis or fibrosing cholestatic hepatitis.This protocol will be opened at specific clinical sites for the treatment of individual subjects for whom there are no other treatment options and will allow for the collection of safety and efficacy data.

This study will evaluate the efficacy, safety, and tolerability of sofosbuvir (SOF)/GS-5816 fixed dose combination (FDC) with and without ribavirin (RBV) for 12 weeks and SOF/GS-5816 FDC for 24 weeks in adults with hepatitis C virus (HCV) infection and Child-Pugh (CPT) class B cirrhosis.

The purpose of this study is to determine the effectiveness of using a combination of two different drugs in preventing the transmission of HCV from a HCV positive donor to a HCV negative solid organ recipient. Both drugs are FDA-approved. Mavyret™ is currently used commercially to treat Hepatitis C and Zetia® is used commercially to treat high cholesterol.

The purpose of this study is to develop an advanced multiparametric liver magnetic resonance elastography (MRE) imaging technology for monitoring hepatic inflammation during direct acting antiviral (DAA) treatment, evaluation risks of severe liver injury, and HCC development.

A Phase 3b, single arm, open-label, multicenter study to evaluate the safety and to demonstrate the non-inferiority of the sustained virologic response 12 weeks post dosing (SVR12) rates of 8 weeks of treatment with the glecaprevir (GLE)/pibrentasvir (PIB) combination regimen to the historical SVR12 rate of 12 weeks of treatment with the GLE/PIB in treatment-naïve adults with chronic HCV GT 1, 2, 4, 5, or 6 infection and compensated cirrhosis.

A Study to Evaluate the Safety and Efficacy of Ombitasvir/ABT-450/Ritonavir and Dasabuvir in Adults with Genotype 1b Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis.

The purpose of this study is to find the rate of Hepatitis B, Hepatitis C, and Hepatocellular Carcinoma in individual populations of African descendants living in Minnesota, and to see what the current knowledge, attitudes and practices of these immigrants are towards screening, vaccination, and disease management.

This open-label study will evaluate safety, pharmacokinetics and efficacy of a 12 or 24 week regimen of ombitasvir/ABT-450/ritonavir and dasabuvir with or without ribavirin in HCV-genotype 1-infected subjects with an Estimated Glomerular Filtration Rate (eGFR) <30, including those on hemodialysis.

The purpose of this study is to establish the Maximum Tolerated Dose (MTD), assess the safety, tolerability, and pharmacokinetics of subcutaneous PHIN-214 in participants with compensated and decompensated cirrhosis. In addition, various exploratory markers of effectiveness will be analyzed. 

The purose of this study is to assess the effectiveness, safety, and tolerability of LPCN 1148 in men with cirrhosis of the liver and sarcopenia.

We purpose of this study is to evaluate the diagnosis accuracy of the Controlled Attenuation Parameter (CAP) measured by FibroScan® (both with M and XL probes) in all patients who are undergoing liver biopsy for any liver disease.