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Hepatitis clinical trials

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NCT ID: NCT02601040 Completed - Hepatitis A Clinical Trials

Immunogenicity and Safety of Inactivated and Live Attenuated Hepatitis A Vaccines

Start date: November 2011
Phase: Phase 4
Study type: Interventional

The main purpose of this study was to evaluate the safety and immunogenicity of Immunogenicity of Inactivated and Live Attenuated Hepatitis A Vaccines for healthy Chinese people.

NCT ID: NCT02600325 Completed - Hepatitis C Clinical Trials

Dutch Acute HCV in HIV Study (DAHHS-2): Grazoprevir/Elbasvir for Acute HCV

DAHHS-2
Start date: February 2016
Phase: Phase 3
Study type: Interventional

New and recently EMA/FDA approved direct acting antiviral (DAA) combination therapies cure 95% or more of the patients chronically infected with HCV genotype 1 and 4. Grazoprevir (MK-5172) and elbasvir (MK-8742) combination therapy is such a, albeit not yet EMA/FDA approved combination DAA therapy. It is likely that the synergistic effect of the host's immune response and antiviral therapy when given during the first 6 months of HCV infection makes antiviral therapy during acute HCV infection more effective. In this study the investigators would like to document that treatment of acute HCV with grazoprevir (MK-5172), elbasvir (MK-8742) is effective and can ben shortened from 12 to 8 weeks for HCV genotype 1 and 4 infection without substantial loss in efficacy. Study design and intervention: Prospective open label interventional clinical trial in which 80 acute HCV genotype 1 or 4 patients co-infected with HIV will receive 8 weeks of grazoprevir and elbasvir (a once-daily combination tablet). Study population: 80 Adult HIV positive patients with an acute HCV genotype 1 or 4 infection from 10 HIV treatment centers in the Netherlands and Belgium will be included. Primary endpoint: Sustained viral response (SVR) 12 weeks after the end of therapy in ITT study population (=genotype 1 and 4).

NCT ID: NCT02600117 Completed - Clinical trials for Hepatitis B, Chronic

Use of TDF in Patients With Inactive Chronic Hepatitis B Infection

Start date: January 26, 2016
Phase: Phase 3
Study type: Interventional

Recent evidence suggests that patients with inactive chronic hepatitis B (CHB) may develop the same types of liver complications that patients in the active state of hepatitis B virus (HBV) infection experience. Treatment guidelines for patients in the active state of HBV infection indicate that HBsAg clearance is associated with definitive remission of the activity of chronic HBV & improved long-term outcome. Clinical data showed that HBsAg clearance is achievable, in a small population of patients on continuous treatment with potent oral antivirals (OAVs), such as tenofovir disoproxil fumarate (TDF). It is possible the same OAVs can have the same effect in patients with inactive CHB, but in a shorter treatment duration. The purpose of this study is to find out if TDF is effective in controlling HBV DNA & promoting seroconversion from HBsAg-positive to HBsAb-positive in patients with inactive CHB.

NCT ID: NCT02598063 Completed - Clinical trials for Hepatitis B, Chronic

A Study to Evaluate Efficacy and Safety of Peginterferon Alfa-2a (Pegasys) and Adeforvir Dipivoxil (ADV) in Participants With Lamivudine-Resistant Hepatitis B e Antigen (HBeAg)-Positive Chronic Hepatitis B

Start date: October 2005
Phase: Phase 4
Study type: Interventional

This study will evaluate the efficacy and safety of peginterferon alfa-2a or ADV, in participants with lamivudine-resistant HBeAg-positive chronic hepatitis B. Participants will be randomized to receive either peginterferon alfa-2a for 48 weeks in combination with oral lamivudine for the first 12 weeks, or ADV for 72 weeks in combination with oral lamivudine for the first 12 weeks. The anticipated time on study treatment is 72 weeks, and the target sample size is 255 individuals.

NCT ID: NCT02597790 Completed - HIV Clinical Trials

A Prospective, Longitudinal Study of Endothelial Function in HIV/HCV Coinfected Subjects

CTSI-PLACE
Start date: October 2013
Phase:
Study type: Observational

The CTSI-PLACE Study is a study for men and women with HIV/hepatitis C co-infection or HIV only. The study looks at the impact of having hepatitis C virus in addition to HIV on risk for cardiovascular disease. Participants will undergo non-invasive assessment of cardiovascular disease risk through measurements of endothelial function and blood biomarkers at baseline and 1 year (or 4 weeks and 24 weeks after end of HCV treatment for those that undergo HCV treatment during study follow-up).

NCT ID: NCT02597270 Completed - Hepatitis C Virus Clinical Trials

An Observational/Non-interventional, Study of NS3/4a Protease and NS5A Protein of Hepatitis C Virus in Brazilian Participants With Chronic HCV Infection

MAPPING
Start date: March 2016
Phase: N/A
Study type: Observational

The purpose of this study is to describe the genetic diversity of Hepatitis C virus (HCV) NS3/4a protease and NS5A protein of HCV in participants with chronic disease naive-drug or previously failed to double therapy (Peg-interferon and Ribavirin) and to identify the frequency of natural polymorphisms in HCV NS3/4a protease and NS5A protein that are associated with direct-acting antivirals (DAAs)-resistance.

NCT ID: NCT02597166 Completed - Clinical trials for Hepatitis C, Chronic

Effects of Harvoni in Patients With Decompensated Cirrhosis Due to Hepatitis C Genotype 1 Infection

Start date: January 2016
Phase: Phase 3
Study type: Interventional

There are now several licensed drug treatments for patients with HCV infection. These medications have been shown to be very effective in getting rid of the virus in patients with HCV infection including those with early stages of cirrhosis without complications known as compensated cirrhosis, with a greater than 90% cure rate. At present, there are very little data to show that treating patients with HCV infection and decompensated cirrhosis will give the same effects. However, patients with decompensated cirrhosis as a result of hepatitis B infection who received treatment to control their virus show improvement of their overall liver condition, and the liver complications of many of these patients disappeared. Also, patients with cirrhosis due to excess alcohol and who stopped drinking also showed improvement in liver function and their complications of cirrhosis coming under control. Therefore, treatment of patients with HCV infection and decompensated cirrhosis is expected to show the same positive effects, because the underlying cause of cirrhosis is coming under control. Harvoni is a combination of two direct-acting antivirals (ledipasvir and sofosbuvir) that prevents the hepatitis C virus from copying and multiplying themselves, allowing the body to clear the virus from their systems and be cured of HCV infection. This study is being conducted to find out if treatment with Harvoni will lead to clearance of HCV infection in patients with decompensated cirrhosis giving rise to improvement in liver function, together with improvement of quality of life and survival.

NCT ID: NCT02596880 Completed - Hepatitis C Clinical Trials

Sofosbuvir, Daclatasvir, Ribavirin for Hepatitis C Virus (HCV) Cirrhotics

SD100
Start date: September 2015
Phase: Phase 3
Study type: Interventional

The investigators will treat 100 patients with cirrhosis due to hepatitis C with sofosbuvir 400 mg daily, daclatasvir 60 mg daily and weight-based ribavirin (1000 mg/d if <75 kg, 1200 mg/d if >75 kg, divided in two daily doses) for 12 weeks and calculate the sustained viral response rate at 12 weeks.

NCT ID: NCT02595710 Completed - Clinical trials for Cryptogenic Cirrhosis

Bartonella in Liver Transplant Patients

Start date: December 2013
Phase:
Study type: Observational

Approximately 20 volunteers who have received a liver transplant and have been diagnosed with cryptogenic cirrhosis will be included in this study. Blood, skin and urine samples will be analyzed for Bartonella spp..

NCT ID: NCT02594293 Completed - Chronic Hepatitis B Clinical Trials

Pegylated Interferon(Peg-IFN) in Reducing Relapse Rate in Patients After Discontinuation of NUC Therapy

Start date: October 2015
Phase: Phase 4
Study type: Interventional

This study evaluates whether Peg-IFN alfa-2a can reduce the recurrence rate of hepatitis B in 96 weeks after nucleoside analogue (NUC) withdrawal. The HBV HBeAg-Negative patients who received NUC anti-virus treatment for 2.5 years and reached stopping rule in 《Chinese chronic hepatitis B prevention and treatment guidelines》(2010) were randomly assigned into three groups: One group discontinue the NUC treatment and follow up for 96 weeks,One discontinue the NUC treatment ,receive Peg-IFN alfa-2a 180 μg by week for 24 weeks and follow up for 72 weeks,The other discontinue the NUC treatment ,receive Peg-IFN alfa-2a 180 μg by week for 48 weeks and follow up for 48 weeks.