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Hepatitis, Chronic clinical trials

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NCT ID: NCT03439488 Completed - Chronic Hepatitis B Clinical Trials

A Study of Orally Administered JNJ-440 to Evaluate the Safety, Tolerability, and Pharmacokinetics After Single Ascending Doses Including Food Effect Evaluation; After Multi-Day Dosing in Healthy Participants; and After Multiple (Ascending) Doses in Participants With Chronic Hepatitis B

Start date: March 26, 2018
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety and tolerability of JNJ-440 in healthy and Chronic Hepatitis B (CHB) participants after single and multiple doses; and to evaluate the pharmacokinetic (PK) of JNJ-440 in healthy participants and in CHB participants following single and multiple dose regimens, administered alone (healthy participants and CHB participants).

NCT ID: NCT03430830 Completed - Chronic Hepatitis c Clinical Trials

A Study to Evaluate the Pharmacokinetics and Safety of ASC16 Tablets in Healthy Volunteers in China

Start date: January 15, 2018
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the pharmacokinetics and safety of ASC16 after 3-single dose(50mg、100mg、200mg) or fixed continuous dose(200mg) in healthy volunteers.

NCT ID: NCT03426618 Completed - Hepatitis B Clinical Trials

A Real-World Observational Study for the Safety and Efficacy of Baraclude in Korean Pediatric Patients With Chronic Hepatitis B

Start date: January 12, 2018
Phase:
Study type: Observational

This is a local, prospective observational study (regulatory post marketing surveillance) to access the safety and effectiveness of Baraclude in Korean pediatric patients with chronic HBV infection who are between the ages of 2 and less than 16 years.

NCT ID: NCT03373396 Completed - Fibrosis, Liver Clinical Trials

Impact of Chlordecone on Active Chronic Hepatitis

HEPATOCHLORD
Start date: November 8, 2011
Phase: N/A
Study type: Interventional

Chlordecone is known to induce liver damage in rat and mice but no data exists in human being. However chlordecone was used until 1993 in French West Indies for banana fields, it is important to test what damage can be induced now, for patients exposed. We should consider chlordecone as a potential cofactor of liver fibrosis. So we have chosen to compare two populations of chronic hepatitis B, C or alcoholic, with cirrhosis or without fibrosis due to active hepatitis, who had been exposed to chlordecone.

NCT ID: NCT03348059 Completed - Chronic Hepatitis c Clinical Trials

Anti-E1E2 (D32.10 Epitope-binding) Antibodies Status Prior Therapy Favors Direct-acting Antiviral Treatment Efficacy

Start date: October 1, 2015
Phase: N/A
Study type: Observational

The hypothesis was to check whether baseline anti-E1E2 antibodies could predict virological outcome in Hepatitis C virus (HCV)-infected patients receiving direct-acting antiviral treatment

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: NCT03329820 Completed - Clinical trials for Chronic Hepatitis B Infection

Quality of Life and Health Utility of Patients With CHB Infections

Start date: November 2006
Phase: N/A
Study type: Observational

The aim of the study is to assess the health-related quality of life (HRQOL) and preference-based health utilities of chronic hepatitis B (CHB) carriers in different stages of illness. It will also estimate the cost-effectiveness of anti-viral treatments resulting from the prevention of the progression of disease from uncomplicated CHB carriers to cirrhosis and hepatocellular carcinoma (HCC). The following hypotheses will be tested: 1. Patients with chronic hepatitis B virus (HBV) have poorer health-related quality of life (HRQOL) than the general population; 2. Patients with more severe stages of chronic HB infections have lower health related quality of life and health utility values; 3. Anti-viral treatment can improve the HRQOL and health utility for patients with CHB infections; 4. The cost-effectiveness of different treatments for chronic HBV infections can be directly compared in terms of cost/QALY gained.

NCT ID: NCT03320616 Completed - Clinical trials for Hepatitis B, Chronic

EYP001a Food Effect Study in Subjects With Chronic Hepatitis B Virus (HBV) Infection

Start date: February 10, 2017
Phase: Phase 1
Study type: Interventional

The farnesoid X receptor (FXR) regulates hepatitis B virus replication through the bile acids pathway. EYP001a is a selective, synthetic FXR agonist under development for the treatment of hepatitis B. This Phase 1 study is designed primarily to assess Pharmacokinetics (PK) under fed and fasted conditions, and to assess the safety, tolerability and Pharmacodynamics (PD) of single oral doses of EYP001a in subjects with chronic HBV infection.

NCT ID: NCT03313154 Completed - Clinical trials for Cognitive Impairment

Impact on QoL and Cognitive Functioning of New Antiviral Therapies in Subjects With Chronic Hepatitis HCV-related

Start date: November 2015
Phase:
Study type: Observational

Chronic hepatitis HCV-related is the most common cause of chronic liver disease in Italy. Patients with chronic hepatitis C present a prevalence of depressive disorders higher than that of the general population; moreover, it has been repeatedly demonstrated the presence of cognitive deficits and poor quality of life. Chronic hepatitis C therapy was based on the combined use of pegylated alpha-interferons (PEG-INF), and ribavirin. Recently, new therapeutic protocols have been introduced, and while some antiviral drugs, including the first-generation ones, were used only in combination with PEG-IFN and ribavirin, the second and third generation antiviral drugs protocols are interferon-free. However, because of the high cost, the access to interferon-free protocols is only for patients with advanced fibrous stages, or with concomitant extra-hepatic HCV-related diseases, or for transplanted patients. Many side effects, such as flu-like symptoms, and psychiatric symptoms (depression, anxiety, irritability, insomnia) are common during antiviral therapy with IFN. However, in patients with chronic hepatitis C, a high lifetime prevalence of major depressive disorder, panic disorder, and brief recurrent depression have been observed, irrespective of IFN treatment and the use of alcohol and narcotics; such associations between mood and anxiety disorders and chronic hepatitis C may reflect a high prevalence of bipolar spectrum disorders. The presence of severe psychopathological symptoms requires the reduction of posology and causes high rates of discontinuation of antiviral therapy. This project represents an innovative psychiatric and neuropsychological screening program for patients with chronic hepatitis C, eligible for antiviral therapy. 1. Primary objectives: 1. to verify the medium-term impact of new antiviral therapies on quality of life, psychological well-being and cognitive function in subjects with chronic hepatitis C; 2. to verify the predictability of specific psychopathological components and specific determinants on compliance with new antiviral therapies. 2. Main secondary objectives: 1. to verify the evidence of association between various psychiatric disorders and cognitive deficits and chronic hepatitis C; 2. to evaluate the relative weight of psychopathological and/or cognitive disorders on the efficacy of antiviral therapy and on quality of life.

NCT ID: NCT03303599 Completed - Hepatitis C Clinical Trials

Study of the Effectiveness and Clinical Practice Use of Glecaprevir Plus Pibrentasvir in Patients With Chronic Hepatitis C Genotypes 1 to 6

Start date: November 13, 2017
Phase:
Study type: Observational

The interferon- and ribavirin- (RBV) free combination regimen of glecaprevir plus pibrentasvir (GLE/PIB) for the treatment of genotypes 1 to 6 of chronic hepatitis C (CHC) viral infection has been shown to be safe and effective in randomized controlled clinical trials. This observational study is an effectiveness research examining the regimen of GLE/PIB, used according to local label, under real world conditions in a clinical practice patient population.