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Hepatitis, Chronic clinical trials

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NCT ID: NCT02300688 Completed - Chronic Hepatitis B Clinical Trials

Bioequivalence Study to Compare the Pharmacokinetics of Besifovir in Healthy Adult Volunteers

Start date: December 2014
Phase: Phase 1
Study type: Interventional

After administration of besifovir preparations different from each other to healthy subjects, the investigators evaluate equivalence of bioavailability of LB80331.

NCT ID: NCT02292719 Completed - Clinical trials for Chronic Hepatitis C Virus Infection

A Study to Evaluate the Safety and Efficacy of Ombitasvir/ABT-450/Ritonavir With Sofosbuvir With or Without Ribavirin in Adults With Chronic Hepatitis C Virus Infection

Quartz II/III
Start date: December 19, 2014
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of Ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) with sofosbuvir (SOF) with or without ribavirin (RBV) in adults with Genotype 2 Chronic Hepatitis C Virus (HCV) infection or Genotype 3 HCV infection with or without Cirrhosis.

NCT ID: NCT02288208 Terminated - Hepatitis B Clinical Trials

Phase I Safety and Tolerability Study of Birinapant in Chronic Hepatitis B

Start date: November 2014
Phase: Phase 1
Study type: Interventional

This study evaluates the addition of birinapant in subjects with chronic Hepatitis B who are currently receiving anti-viral therapy with either tenofovir or entecavir. Patients will receive either birinapant or placebo in addition to their anti-viral therapy.

NCT ID: NCT02287857 Recruiting - Chronic Hepatitis B Clinical Trials

Efficacy and Safety of Domestic Tenofovir Tablets in Chinese Patients With Chronic Hepatitis B

Start date: September 2014
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of Domestic Tenofovir Disoproxil Fumarate Tablets in Chinese patients with hepatitis B ,compared with Tenofovir Disoproxil Fumarate Tablets of Gilead.

NCT ID: NCT02282709 Completed - Chronic Hepatitis C Clinical Trials

Effect of ASV and DCV Therapy on the Quality of Immune Status in Chronic HCV Patients

ImmunoDual
Start date: February 2014
Phase: Phase 3
Study type: Interventional

Rationale: Chronic HCV infection is characterised by a weak HCV specific CD8+ T cell response, due to continuous pressure of high viral load. Treatment of chronic HCV patients with ASV and DCV will result in a significant drop in HCV viral load. At present, no information is available on the immunological effects of treatment with ASV and DCV, nor on the early effects of viral load reduction caused by a compound that is thought not to possess direct immunomodulatory effects. This information will be crucial for a better understanding of the mechanisms that may limit the effectiveness of treatment, occurrence of viral rebound or relapses during, at the end of treatment or during the follow up period. Objective: To evaluate in detail the functionality of immune cells in blood in chronic HCV patients before, during and after treatment with ASV and DCV, in an IFN-free regimen. Study design: This is an investigator-initiated single center open label study with one arm of 12 patients. Study population: Adult chronic HCV patients with genotype 1b, who are previous non-responders to the treatment. Intervention (if applicable): All patients will be treated with twice daily a 200 mg oASV and once daily a 60 mg DCV for 24 weeks. Main study parameters/endpoints: 1. Phenotype and function of blood leukocytes during treatment; frequency of HCV-specific T cells, NK cells and monocytes 2. Gene expression levels of leukocyte populations before, during and after treatment 3. Gene expression levels of the type I IFN signaling pathway on whole blood samples 4. Serum cytokines levels using multiplex platforms

NCT ID: NCT02268864 Completed - Clinical trials for Hepatitis C, Chronic

A Study to Assess the Efficacy and Safety of the Combination of Simeprevir and Daclatasvir in Chronic Hepatitis C Genotype 1b-Infected Participants

COMMIT
Start date: January 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the efficacy of a 12- or 24-week treatment regimen of simeprevir in combination with daclatasvir, as measured by sustain virologic response 12 (SVR12), in treatment-naive, chronic hepatitis C virus (HCV) genotype 1b-infected participants who have advanced fibrosis or compensated cirrhosis (METAVIR F3/F4).

NCT ID: NCT02265237 Completed - Hepatitis C Virus Clinical Trials

A Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Ombitasvir/ABT-450/Ritonavir Co-administered With Ribavirin (RBV) in Adults With Genotype 4 Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis (AGATE-1)

AGATE-1
Start date: October 28, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study in HCV genotype 4-infected subjects with compensated cirrhosis is to assess the safety and to compare the percentage of subjects achieving a 12-week sustained virologic response (SVR12), [HCV ribonucleic acid (RNA) < lower limit of quantification (LLOQ) 12 weeks following treatment], to a clinically relevant threshold [based on SVR rates for HCV genotype 4-infected subjects treated with pegylated interferon (pegIFN)/RBV]. The 12 and 16-week arms have been fully enrolled. As of 19 May 2015, they were closed and the two 24-week arms were opened for enrollment.

NCT ID: NCT02263755 Completed - Chronic Hepatitis B Clinical Trials

Establishment of Retrospective and Prospective Multicenter Cohort for Chronic Hepatitis B

Start date: September 2, 2014
Phase: N/A
Study type: Observational [Patient Registry]

According to the World Health Organization about 1,400,000 deaths reported annually, are related to chronic liver disease. Chronic liver disease is very prevalent in South Korea, placing a large economic burden nationwide. Subsequently, an effective and systematized approach to managing chronic hepatitis is imperative in Korea. The natural history of chronic liver disease differs greatly according to race and ethnicity. However, there is scarcity of epidemic data on chronic hepatitis based on Korean patients. Therefore, the investigators plan to establish a retrospective and prospective multicenter cohort for chronic hepatitis B based on Korean patients that may be utilized for various future clinical studies on chronic hepatitis B in Korea, and thereby serve as a basis for the establishment and distribution of clinical guidelines for Korean patients with chronic hepatitis B, as part of a nationwide project supported by the Centers for Disease Control (CDC), Korea. The investigators plan to collect 500 cases as have been advised by the CDC during the study period (September, 2014-March, 2015) from 4 tertiary hospitals located in Korea. In the past 5 years, there have been about 800 subjects with chronic hepatitis B who have undergone liver fibroscan and liver biopsy from these 4 institutions. The investigators plan to register available cases retrospectively from those who are available to agree to give written informed consent to participate in this study, and to register the remaining numbers of cases prospectively, according to the inclusion and exclusion criteria.

NCT ID: NCT02263079 Completed - Clinical trials for Pediatric Immuno-Tolerant Chronic Hepatitis B

A Study of Pegylated Interferon Alfa-2A in Combination With Lamivudine or Entecavir Compared With Untreated Control Group in Children With Hepatitis B Envelope Antigen (HBeAg)-Positive Chronic Hepatitis B (CHB) in the Immune-Tolerant Phase

Start date: June 16, 2014
Phase: Phase 3
Study type: Interventional

This randomized, controlled, parallel group, open-label multicenter study will evaluate the efficacy and safety of a combination of pegylated interferon alfa-2A (Pegasys) plus lamivudine or entecavir compared with an untreated control group in participants with HBeAg positive CHB in the immune tolerant phase. NOTE: STUDY RECRUITMENT HAS BEEN TERMINATED

NCT ID: NCT02262728 Completed - Clinical trials for Hepatitis C, Chronic

An Efficacy, Safety and Pharmacokinetics Study of Simeprevir, Daclatasvir and Sofosbuvir in Participants With Chronic Hepatitis C Virus Genotype 1 or 4 Infection and Decompensated Liver Disease

Start date: September 30, 2014
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the efficacy of a 12-week regimen containing simeprevir, daclatasvir and sofosbuvir in participants with decompensated liver disease (the liver function is insufficient) due to genotype 1 or 4 Hepatitis (inflammation of the liver) C virus (HCV) infection by assessing sustained virologic response 12-weeks after the end of study drug treatment (SVR12).