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Hepatitis clinical trials

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NCT ID: NCT03682549 Completed - Hepatitis C Viral Clinical Trials

Oral Microbiome of Patients With Hepatitis C Virus Infection

Start date: December 1, 2019
Phase:
Study type: Observational

Hepatitis C virus (HCV) infection is very common in Egypt and the middle east. The disease affects multiple body organs and may proceed to hepatocellular carcinoma. The viral disease causes changes in the microbial symbiosis in the human body. Thus, the analysis of the microbiome may provide a means of diagnosis for HCV infection. Thus, this study will be held to detect if the microbiome of patients having HCV differ from that of normal individuals.

NCT ID: NCT03681132 Completed - Clinical trials for Hepatitis B, Chronic

The Norwegian Nucleoside Analogue Stop Study

Nuc-Stop
Start date: September 20, 2018
Phase: Phase 4
Study type: Interventional

Globally, an estimated 257 million individuals have chronic hepatitis B-virus infection (CHB). In the absence of treatment 15-40% of these will progress to liver cirrhosis and/or hepatocellular carcinoma. Oral antiviral treatment suppresses the virus and improves prognosis, but less than 0.5% per year achieve a "functional cure" (i.e. HBsAg loss). One remaining controversy, therefore, is whether antiviral treatment must continue life-long. Observational studies have assessed stopping antiviral treatment after years of viral suppression; however, HBsAg loss has rarely been seen. But interestingly, a few small trials that chose watchful waiting instead of re-initiation of treatment when reactivation occurred, achieved 40% HBsAg loss during 6 years follow-up. The present proposal is a randomized controlled trial that will assess the safety, efficacy, and cost-effectiveness of treatment discontinuation - and delayed restart - in HBeAg negative CHB. The study is sufficiently powered to address the hypotheses, and a pilot study that demonstrates feasibility has been performed. Patients will be enrolled at 12 Norwegian hospitals, in addition to our collaborating institution in Ethiopia - the largest CHB treatment center in sub-Saharan Africa. If the study shows that discontinuation is safe and effective, it will directly impact both national and international treatment guidelines. Main objective: -To study whether stopping nucleoside analogue (NA) therapy - and delaying re-start - can trigger an immune response and set off a functional cure (viz HBsAg loss) Secondary objectives: - Assess whether stopping NA therapy - and delaying re-start - leads to a higher chance of HBsAg loss - Assess the safety of stopping NA therapy - and delaying re-start - in terms of hepatic decompensation, fibrosis progression, and/or adverse events - Study whether stopping NA therapy - and delaying re-start - leads to a higher chance of sustained off-therapy immune control (low viral load and normal ALT) - Assess the quality of life and cost-effectiveness of stopping NA therapy - and delaying re-start - Identify predictors of HBsAg loss

NCT ID: NCT03674125 Completed - HCV Infection Clinical Trials

Evaluation of Safety, Tolerability, and Immunogenicity Study of GLS-6150 in Healthy Volunteers and in Persons Previously Treated for Hepatitis C Virus Infection

Start date: September 4, 2018
Phase: Phase 1
Study type: Interventional

Hepatitis C virus (HCV) is an enveloped, single strand, positive sense RNA flavivirus. Infection by HCV is typically chronic, although an estimated ~10-20% may spontaneously clear the virus. HCV affects between 1.3 - 2 billion individuals, or 2-3% of the global population. HCV has a seroprevalence of approximately 1% in developed countries such as the US and Korea. Chronic HCV infection leads to hepatic fibrosis and cirrhosis. This Phase I study will evaluate the safety, tolerability and immunogenicity of GLS-6150 administered intradermally (ID) followed by electroporation at 1.0 mg and 2.0 mg/dose assessing 3 and 4-dose regimens.

NCT ID: NCT03672188 Completed - Chronic Hepatitis B Clinical Trials

Study of VIR-2218 in Healthy Subjects and Patients With Chronic Hepatitis B

Start date: November 14, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

This is a phase 1/2 study in which healthy adult subjects and subjects with chronic hepatitis B virus (HBV) infection will receive VIR-2218 or placebo and will be assessed for safety, tolerability, pharmacokinetics, and antiviral activity (only in subjects with chronic HBV). In the single ascending dose (SAD) part, Part A, healthy adult subjects will receive one dose of VIR-2218 or placebo, administered subcutaneously (SC). In the multiple ascending dose (MAD) parts, Part B & Part C, subjects with chronic HBV infection will receive two doses of VIR-2218 or placebo every 4 weeks administered SC.

NCT ID: NCT03670251 Completed - Hepatitis C Clinical Trials

Evaluation of Hepatitis C Viral Load Quantification on DBS in Vietnam

MOVIDA-Hep
Start date: May 9, 2019
Phase: N/A
Study type: Interventional

In Vietnam, the prevalence of hepatitis C virus (HCV) infection is estimated between 0.4% and 5%, which is much higher than the prevalence in Europe or in the USA. After HCV diagnosis, HCV viral load quantification is crucial in order to distinguish recovered from active (on-going) HCV infection and hence identify those who need antiviral treatment to cure HCV infection. HCV viral load quantification is also important to assess treatment efficacy. Currently, anti-HCV antibodies detection is available around the country. However, access to confirmation of HCV viremia remains scarce particularly in decentralized areas. One of the reason is the limited number of laboratories able to perform this complex biological measurement; moreover, these laboratories are situated only in large urban centres. Blood sampling using DBS could help overcome this difficulty of access to a laboratory, and widen access to HCV viral load monitoring. The present MOVIDA Hep study aims at validating the use of DBS to measure HCV viral load as compared to plasma (gold standard). A secondary objective is to evaluate the measurement of HCV core antigen on DBS. For this, 315 patients need to be enrolled form outpatient clinics in Hanoi. The laboratory in charge of these measurements would be the virology laboratory of the National Institute of Hygiene and Epidemiology (NIHE) in Hanoi (Vietnam).

NCT ID: NCT03669835 Completed - Hepatitis C Clinical Trials

The Sublimated Mare Milk Supplement in Hepatitis C

Start date: March 28, 2018
Phase: N/A
Study type: Interventional

This clinical trial studies the effect of sublimated mare milk supplement on patients with hepatitis C.

NCT ID: NCT03654677 Completed - Hepatitis A Vaccine Clinical Trials

To Evaluate the Immunogenicity and Safety of Inactivated Hepatitis A Vaccine (VITHA-A)

Start date: September 19, 2017
Phase: Phase 3
Study type: Interventional

The objective of this study is to evaluate the safety and immunogenicity after one primary dose and one additional dose (administered twice at an interval of 6 months) of inactivated hepatitis A vaccine are administered in adolescents (16 years of age or older) or adults.

NCT ID: NCT03654664 Completed - Hepatitis A Vaccine Clinical Trials

To Evaluate the Immunogenicity and Safety of Inactivated Hepatitis A Vaccine

VITHA-C
Start date: June 20, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the immunogenicity and safety after one primary dose and one additional dose of inactivated hepatitis A vaccine are administered in Korean healthy children aged 12-23 months.

NCT ID: NCT03654365 Completed - Hepatitis C Clinical Trials

Advanced Electronic Population Health and Personal Health Record Tools to Improve Once Lifetime Hepatitis C Screening

Start date: November 17, 2016
Phase: N/A
Study type: Interventional

This study involves randomizing patients due for once in a lifetime Hepatitis C screening based on Center for Disease Control and Prevention and United States Preventative Services Task Force guidelines in one of three primary care clinics within the MetroHealth System to bulk messaging and bulk ordering for HCV antibody vs usual care (routine alerting).

NCT ID: NCT03652675 Completed - Hepatitis C Clinical Trials

Understanding and Intervening With Heavy Drinking Among Patients With HIV and HCV

Start date: November 1, 2018
Phase: N/A
Study type: Interventional

Among patients with HIV, especially those also infected with HCV, heavy drinking is associated with significant risks to health. However, little is known about how to best intervene with co-infected heavy drinkers, a particularly high risk group for whom targeted intervention has not been developed. Therefore, this study proposes to test a newly developed drinking-reduction intervention for patients with both HIV and HCV, which combines components of successful interventions developed for HIV and for liver disease patients. 60 HIV/HCV co-infected drinkers from HIV primary care will be recruited in order to ensure an adequate final sample size of 45 participants completing the study. A clinic recruiter will identify and refer potential participants based on their medical record, who will then be screened for eligibility by the research coordinator. Potential participants from outside of this clinic will also be recruited through self-referrals via flyers and through RecruitMe, an online based recruitment tool. Participants will be randomly assigned to an intervention or control condition, while ensuring that equal numbers of individuals with alcohol use disorder are assigned to each condition. The intervention condition will receive brief in-person sessions with a counselor and will be asked to use a smartphone app daily to keep track of drinking and other health behaviors for two months. The intervention sessions will include information about HIV, HCV and alcohol, and the counselor will give the participant information about their liver function and alcohol use to try to motivate them to drink less. The control condition will simply be asked to drink less and will be given pamphlets with general information on HIV, Hepatitis C, and drinking from educational websites on HIV/HCV co-infection. The intervention condition will then be evaluated to see if it was more effective at reducing drinking than the control condition.