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Hepatitis clinical trials

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NCT ID: NCT03365921 Completed - Hepatitis E Clinical Trials

A Phase Ⅳ Clinical Trial of the Recombinant Hepatitis E Vaccine (Escherichia Coli)(the Lot Consistency Trial)

Start date: October 27, 2018
Phase: Phase 4
Study type: Interventional

This study is to evaluate lot-lot consistency of Recombinant Hepatitis E Vaccine (Escherichia Coli) Hecolin®.

NCT ID: NCT03365635 Completed - Hepatitis C Clinical Trials

Administration of Zepatier (Grazoprevir Plus Elbasvir) in Chronic Hemodialysis (HD) Patients With Hepatitis C

HD
Start date: September 22, 2019
Phase: Phase 4
Study type: Interventional

This is a study to define strategies for Nephrologists to directly supervise and apply direct acting antivirals to cure hepatitis C in hemodialysis patients. Strategies will include identification of candidate patients, application for insurance approval, specifics of direct acting antiviral therapy (Zepatier with or without ribavirin) and laboratory monitoring during and after therapy.

NCT ID: NCT03362476 Completed - Hepatitis C Clinical Trials

Computer-based Intervention for Alcohol-using HIV/HCV+ Women

Start date: January 3, 2018
Phase: N/A
Study type: Interventional

The study harnessed the multidisciplinary expertise of our research team to develop a brief, computer-based, alcohol reduction intervention tailored for HIV/HCV co-infected women and evaluate its efficacy. The intervention, if effective, may be an efficient and cost-effective alcohol reduction strategy, that is scalable and can be readily disseminated and integrated in clinical care at other AIDS Centres in Russia to enhance women's health and reduce HIV/HCV transmission risk.

NCT ID: NCT03361956 Completed - Hepatitis B Clinical Trials

An Efficacy, Safety, and Pharmacokinetics Study of JNJ-56136379 in Participants With Chronic Hepatitis B Virus Infection

Start date: February 13, 2018
Phase: Phase 2
Study type: Interventional

The main purpose of this study is to evaluate efficacy of 24 weeks of study treatment, in terms of changes in hepatitis B surface antigen (HBsAg) levels.

NCT ID: NCT03351933 Completed - Clinical trials for Anti-Hepatitis A Antibody Levels in Heathy Subjects

Anti-Hepatitis A Virus, Pharmacokinetics, and Safety of Immune Globulin (Human)

GamaSTAN
Start date: October 31, 2017
Phase: Phase 4
Study type: Interventional

This was a single center, open-label, single-arm study in which approximately 28 Hepatitis A virus (HAV)-seronegative healthy subjects were enrolled. There was a screening period of up to 28 days during which subjects were screened for enrollment in the study. Healthy subjects received a single intramuscular (IM) dose of GamaSTAN (0.2 mL/kg), followed by a pharmacokinetic (PK) sampling period of 150 days (approximately 5 half-lives). The protective levels of anti-HAV antibodies were assessed up to 60 days after the administration of GamaSTAN. A PK curve was obtained during the PK sampling period.

NCT ID: NCT03350074 Completed - Clinical trials for Hepatitis B, Chronic

HBV Envelope Proteins Variability on HBs Antigen Clearance Under Nucleos(t)Ide Analogue Therapy

Start date: November 5, 2013
Phase: N/A
Study type: Observational

Hepatitis B virus (HBV) infection remains difficult to eradicate with about 240 million people living with HBV chronic infection. HBsAg clearance, correlated with a good clinical prognosis, is difficult to achieve even with antiviral treatments (3-14 %). HBV envelope proteins are essential for entry into hepatocyte and are targeted by the immune system. Molecular characteristics of HBV envelope proteins may favour better viral fitness at the entry step into hepatocytes and/or HBV escape from host immunity. Here we investigated whether variability of HBV envelope proteins can contribute to the differential responses to anti-HBV treatment in patients with HBsAg clearance or persistence.

NCT ID: NCT03346941 Completed - Chronic Hepatitis c Clinical Trials

Side Effects After Direct-acting Antiviral Treatment

EFINO-C
Start date: May 1, 2016
Phase: N/A
Study type: Observational

The objective of this study was to assess the incidence of side effects after direct-acting antiviral therapy in patients with chronic hepatitis C virus infection.

NCT ID: NCT03345498 Completed - Hepatitis B Clinical Trials

Entecavir for Decompensated HBV Cirrhosis

Start date: January 1, 2017
Phase:
Study type: Observational

Entecavir (ETV) and tenofovir (TDF) are the first-line drugs for treatment of chronic hepatitis B virus (HBV) infection. Chronic HBV infection gradually progress to liver cirrhosis. Over time, as liver damage and cirrhosis advance, the illness progress to a stage termed as decompensated cirrhosis, characterized by development of one or more of serious, life-threatening complications (ascites, hepatic encephalopathy, variceal bleeding or jaundice). In HBV related decompensated cirrhosis, antiviral treatment is shown to provide benefit. For HBV related decompensated cirrhosis, EVT is the drug of choice as it has been shown to be effective and safe. The usual dose of ETV for chronic HBV infection is 0.5 mg orally once daily. Somehow, the recommended dose of ETV for decompensated cirrhosis has been 1.0 mg/d. The literature provides no justification for using this double dose of ETV. Since 0.5 mg daily works well in other stages of disease, there is little reason why it should not work well even in treatment-naïve decompensated cirrhosis. Considering the limitations of available literature, physicians' are divided in their opinion about the drug dose and are prescribing either of the two doses of ETV for this group. Hence, there is a need to assess whether the usual 0.5 mg/d of ETV would work as well as the 1.0 mg/d dose of ETV in decompensated cirrhosis due to HBV infection. Investigators planned this open-labeled observational study with objective to compare the efficacy of HBV suppression achieved using 0.5 mg daily and 1.0 mg daily of ETV in HBV-related decompensated cirrhosis by comparing the mean reduction in HBV DNA level from baseline after 24 weeks of treatment. In present study investigators propose to enroll 15 participants in each group who has been started on either doses (0.5 mg and 1.0 mg) of entecavir and measure serum HBV DNA levels in blood specimens (5 ml) will be collected at different time points, i.e. at baseline, 2, 4, 8, 12 and 24 weeks after starting entecavir.

NCT ID: NCT03343925 Completed - Clinical trials for Hepatitis C, Chronic

Direct-acting Antiviral Therapy and Reinfection Among PWID With Chronic HCV in Community-based Settings

SHARP-C
Start date: August 17, 2018
Phase:
Study type: Observational

SHARP-C is an observational cohort study investigating the effect of direct-acting antiviral (DAA) therapy and reinfection in people with chronic hepatitis C virus (HCV) and recent injecting drug use. A prospective, observational cohort design will be used to enrol patients attending tertiary drug and alcohol and primary health care services. Participants will be prescribed a direct-acting HCV medication as per the standard of care. The on treatment phase will vary dependent on the type of a direct-acting antiviral prescribed as per the standard of care. Once patients have completed their treatment course they will be followed up every 3 months for up to 3 years following the end of treatment phase. The study will aim to evaluate the incidence of HCV reinfection following successful DAA treatment over the three years of follow up. The study will also evaluate the proportion of patients with undetectable HCV RNA at 12 weeks post end of treatment (SVR12) with direct-acting anti-viral HCV therapy.

NCT ID: NCT03342261 Completed - Clinical trials for Hepatitis C, Chronic

Benefit of DAA Therapy in HCV Monoinfected and HIV-HCV Coinfected Patients With Mixed Cryoglobulinemia

Start date: March 1, 2017
Phase: N/A
Study type: Observational

Mixed cryoglobulinemia (MC) is common in patients with chronic hepatitis C virus (HCV) infection. Direct-acting antiviral (DAA) regimens are today very effective with sustained virological response rates (SVR12) above 90%. The objective of this study was to investigate the impact of DAA therapy on cryoglobulin clearance in patients with HCV-associated MC.