Hepatitis C clinical trials at UC Health
25 in progress, 13 open to new patients
A Study to Evaluate the Pharmacokinetics, Safety, and Efficacy of Glecaprevir/Pibrentasvir in Pediatric Subjects With Genotypes 1-6 Chronic Hepatitis C Virus (HCV) Infection
open to eligible people ages 3-17
An open-label study to assess the pharmacokinetics (PK), safety, and efficacy of glecaprevir (GLE)/pibrentasvir (PIB) in pediatric participants divided into 4 age groups: 3 to < 6, 6 to < 9, 9 to < 12, and 12 to < 18 years of age. Within each age group, some participants will be enrolled for intensive pharmacokinetics (IPK) to characterize the PK of a particular age group and the remainder of participants will be enrolled for the evaluation of safety and efficacy of each age group. Intensive PK sampling is designed to allow for dose adjustment, based on available PK and clinical data to achieve therapeutic exposures that have been safe and efficacious in adults. Part 1 of the study will enroll participants into Cohort 1; Cohort 1 will include participants who are in 12 to < 18 years of age who can swallow the adult formulation of GLE/PIB. Part 2 of the study will enroll participants in the remaining age groups into Cohorts 2, 3, and 4; participants in these cohorts will receive the pediatric formulation of GLE/PIB. All participants will receive GLE/PIB for 8, 12, or 16 weeks depending on their hepatitis C virus (HCV) genotype, cirrhosis, and prior treatment experience status.
at UCSF
Best dose of navitoclax with sorafenib tosylate to treat patients with tumors that have returned/not responded to treatment
“Can Navitoclax and sorafenib tosylate stop the growth of tumor cells by blocking some of the enzymes needed for cell growth?”
open to eligible people ages 18 years and up
This phase I trial studies the side effects and the best dose of navitoclax when given together with sorafenib tosylate in treating patients with solid tumors that have returned (relapsed) or do not respond to treatment (refractory). Navitoclax and sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
at UC Davis
Direct Acting Antiviral-Post Authorization Safety Study
open to eligible people ages 18 years and up
This is an independent optional sub-study parallel to TARGET-HCC (NCT02954094). The purpose of Direct-Acting Antiviral-Post Authorization Safety Study (DAA-PASS) is to investigate the impact of exposure to direct-acting antivirals (DAAs) on early recurrence of hepatocellular carcinoma (HCC) in hepatitis C virus (HCV)-infected patients following successful HCC treatment interventions.
at UC Davis
Elbasvir (EBR)/Grazoprevir (GZR) in Pediatric Participants With Chronic Hepatitis C Infection (MK-5172-079)
open to eligible people ages 3-17
The purpose of this study is to assess the pharmacokinetics (PK), safety, and efficacy of MK-5172, a fixed dose combination (FDC) of elbasvir (EBR) and grazoprevir (GZR) in pediatric hepatitis C virus (HCV)-infected participants aged 3 years up to 18 years.
at UCSF
Harvoni Treatment Porphyria Cutanea Tarda
open to eligible people ages 18 years and up
In the medical literature there case reports that Harvoni improves symptoms in patients with PCT. However, this has never been systematically tested. Therefore, the purpose of this study is to assess whether Harvoni alone is an effective therapy of active PCT in patients with Chronic Hepatitis C.
at UCSF
HCV-TARGET- Hepatitis C Therapeutic Registry and Research Network
open to eligible people ages 18 years and up
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.
at UCSD UCSF
Hepatitis C (HCV) Cure and Kidney Health
open to eligible people ages 18 years and up
The purpose of this study is to learn how 12 weeks of HCV treatment with elbasvir and grazoprevir (brand name Zepatier) impacts your kidney function.
at UCSF
Impact of DAA Uptake in Controlling HCV Epidemic and Modeling Interventions for HCV Elimination Among HIV-infected Persons in San Diego
open to eligible people ages 18 years and up
A retrospective and prospective study among people living with HIV (PLWH) that assesses hepatitis C (HCV) treatment uptake during periods before and after direct acting antivirals (DAA) introduction, and its impact on the HCV epidemic among PLWH.
at UCSD
Impact of Hepatitis C Virus Therapy on Central Nervous System Outcomes
open to eligible people ages 18 years and up
This partially blinded placebo-controlled trial will determine the impact of curing Hepatitis C Virus (HCV) with an oral direct-acting antiviral (DAA), ledipasvir and sofosbuvir in a single pill, on central nervous system (CNS) outcomes in mono- or Human Immunodeficiency Virus (HIV) co-infected individuals.
at UCSD
Mild Hypothermia and Acute Kidney Injury in Liver Transplantation
open to eligible people ages 18 years and up
Acute kidney injury (AKI), or worsening kidney function, is a common complication after liver transplantation (20-90% in published studies). Patients who experience AKI after liver transplantation have higher mortality, increased graft loss, longer hospital and intensive care unit stays, and more progression to chronic kidney disease compared with those who do not. In this study, half of the participants will have their body temperature cooled to slightly lower than normal (mild hypothermia) for a portion of the liver transplant operation, while the other half will have their body temperature maintained at normal. The study will evaluate if mild hypothermia protects from AKI during liver transplantation.
at UCSF
Monitoring SOF/VEL in Treatment Naïve, HCV Participants With Active Infection
open to eligible people ages 18 years and up
This study is being done to see if a minimal monitoring approach is effective and safe when providing HCV treatment. The minimal monitoring approach will require fewer study visits and lab tests with no medication refills. This study is trying to see whether taking an HCV treatment with fewer clinic visits and laboratory tests can cure just as many people as the standard approach that uses more visits and laboratory tests. The results of this study will be compared with what has been observed in other studies using a standard approach.
at UCLA UCSD UCSF
Prevention of De Novo HCV With Antiviral HCV Therapy Post-Liver and Post-Kidney Transplant
open to all eligible people
In this study, subjects that do not have Hepatitis C virus (HCV) will be transplanted with livers or kidneys from donors who do have HCV. Medications that are used to treat HCV will be given to the study subjects shortly after transplant to protect them from developing the problems HCV can cause to the liver.
at UCSF
Sofosbuvir/Velpatasvir in Adolescents and Children With Chronic HCV Infection
open to eligible people ages 3-17
This study will have 2 parts: Pharmacokinetics (PK) Lead-in Phase and the Treatment Phase. The primary objective of the PK Lead-in Phase is to evaluate the steady state PK and confirm the dose of sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) in pediatric participants with chronic hepatitis C virus (HCV) infection. The primary objective of the Treatment Phase is to evaluate the safety and tolerability of SOF/VEL for 12 weeks in pediatric participants with chronic HCV.
at UCSF
A Prospective, Longitudinal Study of Endothelial Function in HIV/HCV Coinfected Subjects
Sorry, in progress, not accepting new patients
The CTSI-PLACE Study is a study for men and women with HIV/hepatitis C co-infection or HIV only. The study looks at the impact of having hepatitis C virus in addition to HIV on risk for cardiovascular disease. Participants will undergo non-invasive assessment of cardiovascular disease risk through measurements of endothelial function and blood biomarkers at baseline and 1 year (or 4 weeks and 24 weeks after end of HCV treatment for those that undergo HCV treatment during study follow-up).
at UCLA
A Registry for Adolescent and Pediatric Participants Who Received a Gilead Hepatitis C Virus Direct Acting Antiviral (DAA) in Gilead-Sponsored Chronic Hepatitis C Infection Trials
Sorry, accepting new patients by invitation only
This Registry will enroll adolescent and pediatric participants who received at least one Gilead Hepatitis C Virus (HCV) direct acting antiviral (DAA) while participating in a Gilead-sponsored chronic hepatitis C clinical trial. The primary objective of this Registry is to determine the long-term safety of anti-HCV regimens in the pediatric population. Secondary objectives of this Registry are to determine whether subsequent detection of HCV RNA in participants who relapse following sustained virologic response (SVR) represents the re-emergence of pre-existing virus, the development of resistance mutations, or whether it is due to re-infection, and to characterize resistance mutations and the persistence of resistance mutations in pediatric participants who did not achieve SVR. Once enrolled, participants will be followed for up to 5 years.
at UCSF
A Registry for Participants With Cirrhosis Who Achieve a Sustained Virologic Response Following Treatment With a Sofosbuvir-Based Regimen Without Interferon for Chronic Hepatitis C Infection
Sorry, in progress, not accepting new patients
This Registry will enroll cirrhotic participants with or without decompensated liver disease who have achieved a sustained virologic response (SVR) after receiving a sofosbuvir (SOF)-based regimen without interferon (IFN) while participating in a Gilead-sponsored hepatitis C virus (HCV) study or commercially at selected sites. Once enrolled, participants will be followed for up to 5 years.
at UCSD UC Davis UCSF
A Study to Evaluate Treatment of Hepatitis C Virus Infection in Pediatric Subjects
Sorry, in progress, not accepting new patients
The purpose of this three part study is to evaluate the pharmacokinetics (Part 1), safety/efficacy (Part 2), and long-term follow-up (Part 3) of ombitasvir (OBV), paritaprevir (PTV), ritonavir (RTV) with or without dasabuvir (DSV) and with or without ribavirin (RBV) in pediatric subjects with genotype 1 or 4 chronic hepatitis C virus (HCV) infection.
at UCSF
Assessing Long-term CTN 0049 Outcomes, HCV Prevalence and Progression Along the HCV Care Continuum Among HIV/HCV Co-infected Substance Users in the U.S.
Sorry, in progress, not accepting new patients
Primary Objective: This study will evaluate the effectiveness of an HCV Care Facilitation intervention in moving HIV/HCV co-infected substance users forward along the HCV care continuum (compared with a Control group). Primary Hypothesis: The number of steps achieved along the HCV care continuum will differ between the two study groups over the 14-month follow-up period. Secondary Objectives: Component 1 (Long-term CTN 0049 follow-up): Using the CTN 0064 baseline data (self-report, medical record abstraction and biological data), the following CTN 0049 primary and secondary outcomes in participants who consented to the CTN 0064 protocol will be re-analyzed to evaluate latent and/or enduring effects of the CTN 0049 interventions: 1. HIV virological suppression 2. HIV primary care visit attendance 3. All-cause mortality
at UCSF UCLA
Curing HCV in Incarcerated Patients
Sorry, accepting new patients by invitation only
Curing HCV in Incarcerated Patients (CHIP) is a 1-year demonstration project that will assess the feasibility of a HCV treatment program in the San Francisco City & County Jail. The Jail Health Services will treat 100 patients using the FDA approved combination treatment, sofosbuvir/velpatasvir, Epclusa® and will continue their treatment during incarceration and after their release (if applicable).
at UCSF
Digimeds to Optimize Adherence in Patients With Hepatitis C and Increased Risk for Nonadherence
Sorry, in progress, not accepting new patients
This study evaluates the ability of digital medicines, Proteus Discover, to promote adherence and thus achieving a cure for hepatitis C in patients at high risk for not adhering to their hepatitis therapy. In this single-arm, prospective study, subjects at high risk for nonadherence will be prescribed hepatitis C therapy that will be co-encapsulated with ingestible sensors (creating the digital medicine) by a pharmacy. Both the subject and the providers will have access to the ingestion adherence.
at UCSF
Effects of Health Literacy and HCV Knowledge on HCV Treatment Willingness in HIV-coinfected Patients
Sorry, accepting new patients by invitation only
A clinical observational study for patients with HIV co-infected with hepatitis C that investigates the levels of their health literacy, hepatitis C and HIV knowledge. Participants will complete a one-time assessment of these studied domains and categorized in three groups defined by their hepatitis C treatment referral status: not-referred, referred-attended, referred and no-show.
at UCSD
Insulin Resistance in HCV Infection
Sorry, in progress, not accepting new patients
The study hypothesis is that the means by which HCV induces glucose intolerance is through impairment of B-cell function and compensatory hyperinsulinemia in predisposed Latinos with insulin resistance and that HCV eradication improves these abnormalities. It is also hypothesized that moderate alcohol consumption impact insulin sensitivity and secretion with Latinos with or without HCV infection.
at UCSF
Multi-Center, Randomized, Open-Label Study of G/P +/- RBV for NS5A + SOF Previously Treated GT1 HCV Subjects
Sorry, accepting new patients by invitation only
The study will enroll well-compensated cirrhotic as well as non-cirrhotic subjects treatment experienced with an NS5a Inhibitor + sofosbuvir and will include patients who did not complete the prescribed duration due to adverse event or any reason other than for non/poor compliance. Subjects will be randomized to 12 or 16 weeks of treatment.
at UCSF
Sofosbuvir Based DAA Therapy in HIV/HCV Coinfected Pre or Post Liver Transplant
Sorry, in progress, not accepting new patients
Retrospective/Prospective, open-label study using sofosbuvir based DAA therapy to treat HIV/HCV coinfected pre or post liver transplant participants
at UCSF
Study of Oral Treatments for Hepatitis C
Sorry, in progress, not accepting new patients
Phase 1 of this study will compare the effectiveness of 3 approved HCV treatment regimens to learn whether they work equally well under real-world conditions. Phase 2 of this study will begin early 2017 and will compare the effectiveness of 2 FDA approved HCV treatments. Patients receiving HCV therapy in community and academic clinics will be offered the opportunity to consent to be randomly assigned to one of three regimens and then observed for outcomes. Once randomized, all medical care, laboratory testing, and any disease or side effect management will be assumed by usual care conditions, and patient-reported outcomes will be collected outside clinic in keeping with pragmatic design principles.
at UCSF UCSD
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