Hepatitis C clinical trials at UC Health
24 in progress, 7 open to eligible people
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
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 study observes the effects of newly developed direct-acting antiviral (DAA) treatments on the central nervous system (CNS) of individuals with chronic Hepatitis C (HCV). The goals of this study are to determine the CNS impact of curing chronic HCV disease with newly established DAA therapies and how HIV alters this relationship.
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
Prevention Support for People Leaving Jail
open to eligible males ages 18-49
This study will provide HIV prevention and related support services to men who have sex with men and transgender women who have substance use disorders and are either leaving jail or recently released from jail, living in a residential facility providing substance use services or supportive housing . The researchers will compare the utilization of HIV prevention and other support services between individuals who receive routine case management provided following enrollment to those who have access to GeoPassport, a global position service (GPS)-based mobile app, incentives, and peer mentor support.
at UCLA
Testing of a Navigation Intervention for Hepatitis C and HIV
open to eligible males ages 18 years and up
This study will evaluate the efficacy of navigation for hepatitis C treatment in people living with both HIV and HCV with criminal justice involvement.
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 participants with cirrhosis 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 UC Davis UCSF
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
Sorry, in progress, not accepting new patients
An open-label study to assess the pharmacokinetics (PK), safety, and efficacy of glecaprevir (GLE)/pibrentasvir (PIB) in Hepatitis C virus (HCV)-infected 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 HCV genotype, cirrhosis, and prior treatment experience status.
at 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
Development of a Community-based HCV Treatment Completion Intervention Among HCV Positive Homeless Adults
Sorry, not yet accepting patients
This randomized controlled trial (RCT) will test the efficacy of a Community Health Worker/Registered Nurse (CHW-RN) HCV intervention for homeless individuals, many who are also drug users. The intervention will be designed during Phase I of the proposal using an iterative process between a Community Advisory Board (CAB) and focus groups. The CHW/RN intervention will occur over a 2 month (8 weeks) period. Homeless adults assigned to the CHW/RN HCV treatment group will receive culturally-sensitive education, case management, and daily DOT delivery of Mavyret™ (pibrentasvir/glecaprevir) by an RN-guided CHW. The CHW will run a brief (20 min) weekly 1:1 education and 20 min case management session over the 8 weeks and will deliver all components of the program (which will be developed and refined during Phase I). The CHW-RN HCV intervention will be compared to a clinic-based standard of care group (cbSOC). Primary outcomes are the completion of the Direct-Acting Agent (DAA) treatment (month 2) and SVR12 Cure (month 5). Secondary outcomes are improved mental health status, decrease in substance use, and improved access to health care, and shelter stability at month 5.
at UC Irvine UCLA
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
Direct Acting Antiviral-Post Authorization Safety Study
Sorry, in progress, not accepting new patients
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 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
Enhancing Electronic Health Systems to Decrease the Burden of Colon Cancer, Lung Cancer, Obesity, Vaccine-Preventable Illness, and LivER Cancer
Sorry, not yet accepting patients
The purpose of CLOVER is to utilize Epic Healthy Planet to increase adherence to United States Preventive Services Task Force (USPSTF) and Centers for Disease Control and Prevention (CDC) recommendations in adults age 50 and older.
at UC Davis UC Irvine
Glecaprevir/Pibrentasvir Fixed-dose Combination Treatment for Acute Hepatitis C Virus Infection
Sorry, in progress, not accepting new patients
The purpose of this study is to assess the efficacy of a fixed dose combination (FDC) of glecaprevir/pibrentasvir (G/P) given for 4 weeks in acute hepatitis C (HCV)-infected participants, with or without HIV-1 coinfection.
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
Monitoring SOF/VEL in Treatment Naïve, HCV Participants With Active Infection
Sorry, in progress, not accepting new patients
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
Natural History of Hepatitis C in Patients With Normal Liver Tests
Sorry, in progress, not accepting new patients
The Major goals of this project was to assess the natural history of disease in chronic hepatitis C patients with normal ALT and to determine the virologic and host factors associated with disease severity.
at UCSF
Navitoclax and Sorafenib Tosylate in Treating Patients With Relapsed or Refractory Solid Tumors
Sorry, in progress, not accepting new patients
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
Prevention of De Novo HCV With Antiviral HCV Therapy Post-Liver and Post-Kidney Transplant
Sorry, in progress, not accepting new patients
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
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 UCSD UCSF
The No One Waits Study: Acceptability and Feasibility of Community-based Point-of-diagnosis HCV Treatment Study
Sorry, not yet accepting patients
Direct-acting antiviral (DAA) therapy for hepatitis C virus (HCV) offers a cure to those with chronic HCV infection. For marginalized communities, linkage to care services often aren't enough to overcome barriers to accessing the medical system. For difficult to link populations, offering treatment at the same non-clinical community space may improve uptake and reduce loss-to-follow-up. The purpose of this 2 year study is to assess the feasibility, acceptability and effectiveness of accelerated initiation of commercially available DAA therapy targeting socially marginalized communities (e.g., medically underserved, homeless, people actively injecting drugs). The study will be carried out at two community sites that perform HCV testing: (a) fixed community site and (b) community mobile site via clinical research van. Participants (n=150) who test anti-HCV positive and HCV RNA positive (chronic infection) are invited to enroll into the no one waits (NOW) Study and begin HCV treatment at point of diagnosis. All evaluation, medication dissemination, and follow-up care will take place at the project site. The investigators will estimate the effect of on-site point-of-diagnosis (POD) treatment on (1) time from HCV testing to treatment initiation, (2) completing treatment, and (3) attaining (sustained virologic response) SVR-12; overall and by study site. A secondary product will be a lesson learned guide of recommendations for implementing a POD on-site test and treat program for dissemination beyond San Francisco.
at UCSF
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