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Hepatitis B, Chronic clinical trials

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NCT ID: NCT02387463 Completed - Chronic Hepatitis B Clinical Trials

Efficacy of Extended Peginterferon Alpha 2a Treatment in HBeAg Positive Chronic Hepatitis B Patients

Start date: March 2012
Phase: N/A
Study type: Observational

The most important method to slow down and stop the liver disease progression in patients with chronic hepatitis B is antiviral therapy, by which to achieve maintaining viral response during treatment or obtain sustained viral response after treatment. The aim of the therapy with interferon is make patients obtain immune control to HBV, in clinical practice, it was expressed as HBeAg seroconversion, HBsAg loss and sustained viral response in HBeAg positive patients. However, those targets can't be get in most patients by 48 weeks of interferon treatment, and some patients need extended treatment to enhance the rate of HBeAg seroconversion and HBsAg loss. In this cohort study, the efficacies of extended therapy of interferon in HBeAg positive chronic hepatitis B patients will be evaluated.

NCT ID: NCT02368288 Recruiting - Chronic Hepatitis B Clinical Trials

Efficacies of Entecavir Add on HBeAg Positive Patients With HBV DNA Positive During Peginterferon Alpha 2a Treatment

Start date: January 2013
Phase: Phase 4
Study type: Interventional

The aim of interferon therapy in HBeAg positive chronic hepatitis B was to make patients obtain immune control to hepatitis B virus defined as occurred HBeAg seroconversion and HBsAg loss with sustained viral response after treatment. However this target could not be get if patients keep HBV DNA positive during interferon treatment and offend relapse after withdraw of treatment. In this trail, Nucleoside(acid) analogues(NA) will add on patients with HBV DNA load ≥1000copies/ml after 6 months of interferon treatment, and the efficacies of the combine therapy were evaluated by the rates of HBeAg seroconversion and HBsAg loss after 48 weeks of combined therapy, compared with control group.

NCT ID: NCT02366247 Active, not recruiting - Clinical trials for Hepatitis B, Chronic

Phase Ⅲ Trial for Combination Treatment of PEG-Tα1 and Adefovir for HBeAg-positive Chronic Hepatitis B

PEG-Ta1
Start date: August 2013
Phase: Phase 3
Study type: Interventional

This trial is to assess the efficacy and safety of Polyethylene Glycol thymosin alpha1 (PEG-Tα1), a new long immunomodulator (Category 1.1 of Chemical Drugs) being developed from Hansoh Pharmaceutical of China, in combination with adefovir in HBeAg-positive patients with chronic hepatitis B.

NCT ID: NCT02366208 Completed - Clinical trials for Hepatitis B, Chronic

Phase II Trial for Combination Treatment of PEG-Tα1 and Adefovir for HBeAg Positive Chronic Hepatitis B

PEG-Ta1
Start date: May 2011
Phase: Phase 2
Study type: Interventional

This trial is to assess the efficacy and safety of Polyethylene Glycol thymosin alpha1 (PEG-Tα1), a new long immunomodulator (Category 1.1 of Chemical Drugs) being developed from Hansoh Pharmaceutical of China, in combination with adefovir in HBeAg-positive patients with chronic hepatitis B.

NCT ID: NCT02365402 Recruiting - Chronic Hepatitis B Clinical Trials

Efficacies of Entecavir Add on HBeAg Negative Patients With HBV DNA Positive During Peginterferon Alpha 2a Treatment

Start date: January 2013
Phase: Phase 4
Study type: Interventional

The aim of interferon therapy in HBeAg negative chronic hepatitis B was to make patients obtain immune control to hepatitis B virus defined as sustained viral response after treatment. However this target could not be get if patients keep HBV DNA positive during interferon treatment and offend relapse after treatment withdraw. In this trail, entecavir will add on patients with HBV DNA load ≥1000copies/ml after 3 months of peginterferon alpha 2a treatment, and the efficacies of the combine treatment will be evaluated by the rate of sustained viral response after 48 weeks of treatment and 24 week follow up.

NCT ID: NCT02364336 Completed - Chronic Hepatitis B Clinical Trials

Add-on Peginterferon Following Nucleos(t)Ide Analogue Treatment

Start date: February 14, 2015
Phase: Phase 2
Study type: Interventional

Background: - Chronic hepatitis B is caused by a virus that infects the liver. Cure is not possible but the virus can be controlled with the use of antiviral medicines,. Researchers think that adding a second antiviral medicine might help. Objective: - To understand how peginterferon might help treat people with chronic hepatitis B. Also, to see if peginterferon is safe to use with other antiviral medications. Eligibility: - Adults age 18 and older who have chronic hepatitis B and had therapy with 1 or more oral medicines for hepatitis B for at least 4 years. Design: - Participants will be screened with physical exam and medical history. They will complete health questionnaires about their levels of fatigue and pain. They will have blood and urine tests. They may have an eye exam. - Participants also will have a Fibroscan. A test to measure how stiff your liver is. - Eligible participants will have a liver biopsy. Blood will be drawn. - Participants will be admitted to the NIH Clinical Center. They will be injected with the study drug. Then they will have a second liver biopsy. They will be discharged 24 hours later. - Participants will give themselves study drug injections under the skin weekly for 24 weeks. - Participants will have 5 clinic visits during the 24-week treatment period. Then they will have follow-up visits every 12 weeks for 48 weeks. - During visits, participants may have a physical exam and medical history. They may have blood and urine tests. They may have a Fibroscan and complete questionnaires. At the final visit, they will also have a Fibroscan.

NCT ID: NCT02362490 Recruiting - Chronic Hepatitis B Clinical Trials

Efficacy of Peginterferon Alpha 2a Therapy in Chronic Hepatitis B Patients Being Treated With Nucleoside(Acid) Analogues

Start date: January 2013
Phase: Phase 4
Study type: Interventional

Antiviral therapy is the most important method to slow and stop the progress of the disease in patients with chronic hepatitis B (CHB). Nucleoside (acid) analogues (NA) can Effectively suppress HBV replication, but it should be continue used and relapse would happen in most patients after withdrawal of therapy. However, long-term use of NA could induce viral resistance mutation lead to loss of efficacy. Interferon treatment can enhance specific and non-specific immune function in chronic hepatitis B patients, make patients get immune control to HBV infection and obtain sustained response after treatment. Thus the CHB patients on the treatment of NA should be stop NA treatment after interferon treatment. In this study, the effects of interferon treatment in CHB patients who were on the NA treatment and obtained HBsAg level≤250 IU/ml.

NCT ID: NCT02360592 Completed - Clinical trials for Hepatitis B, Chronic

Combination Therapy With Interferon Plus Interleukin 2 and Hepatitis B Vaccine in Chronic Hepatitis B Patients

Start date: June 2013
Phase: Phase 4
Study type: Interventional

This study is a multi-center, randomized, prospective, open-label Phase IV Clinical trial to evaluate efficacy and safety of interferon alfa-2b therapy combinated with interleukin 2 and hepatitis B therapeutic vaccine versus interferon alfa-2b alone in chronic hepatitis B patients with entecavir achieving HBeAg seroclearance. Patients were randomized to one of 3 groups to receive different antiviral treatment.

NCT ID: NCT02355951 Completed - Chronic Hepatitis B Clinical Trials

Non-investigational Study to Evaluate Adenovirus Serotype 5 (Ad5) Neutralizing Antibodies (nAb) in Patients With Chronic Hepatitis B Virus (HBV) Mono-infection

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

Objectives: Primary Objective: To identify and preselect patients with chronic HBV mono infection, who are undetectable for anti-Ad5 nAb, currently being treated with nucleo(t)sides, for participation in the TG1050.02 Phase1/1b First in Man (FIM) study. Secondary Objectives: To assess the prevalence of undetectable anti-Ad5 nAb in chronic HBV mono-infected patients. Methodology: Patients with chronic HBV mono-infection, who are currently being treated with nucleo(t)sides for their HBV infection, will be enrolled in this study to measure Ad5 nAb levels. A single peripheral blood collection (4 mL) will be obtained and Ad5 nAb titers will be measured by a central laboratory using a newly validated assay.

NCT ID: NCT02349126 Withdrawn - Chronic Hepatitis B Clinical Trials

Study of ARC-520 in Patient With Chronic Hepatitis B Virus

Start date: February 2015
Phase: Phase 2
Study type: Interventional

Patients with chronic HBV infection will receive ARC-520 in combination with entecavir or tenofovir and be evaluated for safety and efficacy.