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A Study for the Use of Hepatitis C Virus Seropositive Donors into Hepatitis C Seronegative Liver Transplant Recipients
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to utilize liver allografts from HCV seropositive donors into 10 HCV seronegative recipients.
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A Study To Evaluate The Efficacy, Safety, And Pharmacokinetics Of Co-Administration Of ABT-493 And ABT-530 With And Without RBV In Subjects With Chronic Hepatitis C Virus (HCV) Genotypes 2, 3, 4, 5 Or 6 Infection
Scottsdale/Phoenix, AZ
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.
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Study Of Efficacy And Safety Of Grazoprevir (MK-5172) + Elbasvir (MK-8742) With Or Without Ribavirin For Participants With Hepatitis C Genotype 1, 4, Or 6 Infections Who Have Failed Prior Treatment With Pegylated Interferon + Ribavirin (MK-5172-068)
Scottsdale/Phoenix, AZ
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%.
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A Study Comparing Measurements of Response to Antiviral Treatments for Liver Transplant Patients that have Recurrent Hepatitis C
Scottsdale/Phoenix, AZ
The purpose of this study is to measure the rates of continuing viral presence, following anti-viral therapy with combined Peg-Interferon and Ribavirin in patients that have had a liver transplant, are immune suppressed with Neoral or tacrolimus, and have a recurring infection with the Hepatitis C virus.
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A Study To Compare The Effectiveness And Safety Of ABT-493/ABT-530 To Sofosbuvir Given Together With Declatasvir In Adults With A Chronic Hepatitis C Virus Infection
Scottsdale/Phoenix, AZ
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.
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An Expanded Access Study Of Sofosbuvir Combined With Ribavirin And Either With Or Without Pegylated Interferon For Treating Aggressive Post-Transplant Hepatitis C
Jacksonville, FL
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.
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Ledipasvir/Sofosbuvir Fixed-Dose Combination + Ribavirin In Subjects With Chronic HCV With Advanced Liver Disease Or Post-Liver Transplant
Jacksonville, FL
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).
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Gilead Sustained Virologic Response (SVR) Registry
Jacksonville, FL
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.
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Hepatitis C Therapeutic Registry and Research Network
Scottsdale/Phoenix, AZ
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.
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Trial of Anakinra (Plus Zinc), or Prednisone in Patients With Severe Alcoholic Hepatitis
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
Severe AH continues to be associated with a high mortality and represents a significant public health burden. Prednisone is the standard of care but is associated with a modest and transient survival benefit at best and increased risk of severe bacterial and fungal infections. A recent large study indicated that pentoxifylline is not significantly superior to placebo. While several new targets are being evaluated, they are not sufficiently powered to provide definitive data.
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A Registry for Cirrhosis that has a Sustained Virologic Response Following Sofosbuvir-Based Treatment without Interferon, for Patients who have Chronic Hepatitis C Infection
Rochester, MN
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.
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A Study 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
Scottsdale/Phoenix, AZ; Rochester, MN
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.
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Laboratory Assay Optimization 2.0
Rochester, MN
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).
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A Study to Establish an Alcoholic Hepatitis Network
Rochester, MN
The purpose of this study is to create a clinical database and bio-repository by obtaining blood, urine, and stool samples (e.g., biological samples) and personal health information from patients to use in future research studies related to alcoholic hepatitis or other diseases.
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A Registry to Form a Long-Term Therapeutic and Research Network for Hepatitis C
Jacksonville, FL
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.
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A Phase 2b Study in Subjects With Alcoholic Hepatitis to Evaluate Safety and Efficacy of DUR-928 Treatment
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the safety and effectiveness, as determined by 90-day incidence of mortality or transplant, for intravenous (IV) DUR-928 (30 mg or 90 mg) in subjects with severe alcohol-associated hepatitis, also known as severe alcoholic hepatitis, (AH) with pre-treatment Maddrey Discriminant Function (MDF) score ≥ 32 and MELD scores 21-30. Additionally, to evaluate the effectiveness, as determined by 90-day mortality and 28-day mortality with or without transplant for IV DUR-928 (30 mg or 90 mg) in subjects with severe AH.
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A Study to Evaluate and Monitor Hepatitis Activity in Hepatitis C Virus Infection Patients Using Advanced Multiparametric MR Elastography (MRE)
Rochester, MN
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.
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A Study To Evaluate Preemptive Therapy In Hepatitis C Organ Transplant Recipients
Scottsdale/Phoenix, AZ; Jacksonville, FL
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.
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Use Of F-652 In Patients With Alcoholic Hepatitis
Scottsdale/Phoenix, AZ; Jacksonville, FL; Mankato, MN; Rochester, MN
Alcoholic hepatitis is a syndrome of progressive inflammatory liver injury associated with long-term heavy intake of ethanol. The pathogenesis is not completely understood. Patients who are severely affected present with subacute onset of fever, hepatomegaly, leukocytosis, marked impairment of liver function (e.g., jaundice, coagulopathy), and manifestations of portal hypertension (e.g., ascites, hepatic encephalopathy, variceal hemorrhage). However, milder forms of alcoholic hepatitis often do not cause any symptoms. Alcoholic hepatitis usually persists and progresses to cirrhosis if heavy alcohol use continues. If alcohol use ceases, alcoholic hepatitis resolves slowly over weeks to months, sometimes without permanent sequelae but often with residual ...
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A Study to Evaluate Dupilumab as a Treatment for Moderate-to-Severe, Chronic Hepatic Pruritus
Jacksonville, FL
The purpose of this study is to investigate the potential effectiveness of dupilumab in the treatment of moderate-to-severe, chronic hepatic pruritus.
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A Study to Assess the Efficacy, Safety, and Tolerability of Oral LPCN 1148 in Male Subjects With Cirrhosis of the Liver and Sarcopenia
Scottsdale/Phoenix, AZ
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.
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Single And Multiple Dose Escalation Of PHIN-214 In Child-Pugh A And B Liver Cirrhotics
Rochester, MN
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.
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A Study to Evaluate Diagnostic Accuracy of the Controlled Attenuation Parameter(CAP) Measured by FibroScan® in Patients Scheduled for a Liver Biopsy
Rochester, MN
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.