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Hepatitis B, Chronic clinical trials

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NCT ID: NCT01597934 Active, not recruiting - Chronic Hepatitis B Clinical Trials

Antiviral Efficacy of Switching to ETV Plus TDF

Start date: August 2012
Phase: Phase 4
Study type: Interventional

Switching to Entecavir(ETV) plus Tenofovir Disoproxil Fumarate(TDF) combination will result in faster and greater antiviral activity and lower rates of resistance emergence over maintaining Lamivudine(LAM)/Telbivudine(LdT)+Adefovir(ADV) combination in partial responders to LAM/LdT+ADV rescue therapy. Earlier switching to combination with the most potent regimen will be more effective to achieve virologic response(VR) and prevent further resistance emergence. All subjects will orally take assigned drugs once daily for 48 weeks. All subjects will be assessed at baseline and every three months thereafter. Evaluations at each visit will include vital signs, physical examinations, laboratory tests, HBV DNA levels and adverse events. At baseline and every six months thereafter, serum will be assayed for HBV serology. Genotypic analysis will be performed at baseline and 48 weeks.

NCT ID: NCT01594905 Active, not recruiting - Chronic Hepatitis B Clinical Trials

Entecavir Plus Tenofovir Combination in Subjects With Multi-drug Resistant Chronic Hepatitis B Virus Infection

Start date: August 2012
Phase: Phase 4
Study type: Interventional

Entecavir(ETV) plus Tenofovir Disoproxil Fumarate(TDF) combination will show effective antiviral activity and prevent further development of antiviral resistance in hepatitis B e antigen(HBeAg)-positive or -negative Chronic Hepatitis B(CHB) patients who experienced multidrug resistance All subjects will orally take investigational drugs once daily for 48 weeks. All subjects will be assessed at baseline, Week 4, 12, 24, 36 and 48. Evaluations at each visit will include vital signs, physical examinations, laboratory tests and HBV DNA levels. They were also questioned about adverse events and concomitant medications. At baseline and every six months thereafter, serum will be assayed for HBV serology. Genotypic analysis will be performed at baseline and 48 weeks.

NCT ID: NCT01529255 Active, not recruiting - Clinical trials for Hepatitis B, Chronic

EFFORT Extension Study

EFFORT-Ex
Start date: August 2011
Phase: Phase 4
Study type: Interventional

- The purpose of this study is to to prove that the long-term efficacy of strategy of treatment adjustment at W24 according to virological response based on ROADMAP concept is better than standard of care strategy. - To evaluate the off-treatment durability of HBeAg seroconversion in patients who discontinued treatment due to sustained HBeAg seroconversion and HBV DNA<300copies/ml with over 12 months consolidation treatment

NCT ID: NCT01464281 Active, not recruiting - Chronic Hepatitis B Clinical Trials

A Study of Switch From Nucleotide to Peginterferon Alfa-2a in CHB Patients Achieving HBeAg Loss and HBV DNA <200IU/ml

New Switch
Start date: October 2011
Phase: N/A
Study type: Interventional

A Randomized, open-label, multicenter study. The patients after 1-3 years NAs treatment and having achieved HBeAg loss and HBV DNA <200IU/ml will be switched to Pegasys for 48 or 96 weeks (with a 12 weeks period of overlap with the NA for safety reasons). The subjects will be randomized into 2 groups: Group 1 : 48-week standard treatment by Peginterferon alfa 2a 180µg/week Group 2 : 96-week prolonged treatment by Peginterferon alfa 2a 180µg/week. All the patients will be followed up for 48 weeks after discontinuation of the study medication. Note: NAs will be stratified LAM, ETV and ADV, with the ratio 1:1:1.

NCT ID: NCT01374308 Active, not recruiting - Chronic Hepatitis B Clinical Trials

NASVAC Phase-III Trial in Chronic Hepatitis B (CHB) Patients

NASVAC
Start date: June 2011
Phase: Phase 3
Study type: Interventional

The general objective of the present clinical trial is to compare the therapeutic efficacy of a combination therapeutic vaccine containing hepatitis B surface antigen (HBsAg) and hepatitis B core antigen (HBcAg) [later called NASVAC] with a commonly used antiviral drug, pegylated interferon in patients with chronic hepatitis B (CHB).

NCT ID: NCT01341743 Active, not recruiting - Hepatitis B Clinical Trials

Efficacy Optimizing Research of Chronic Hepatitis B Patients With Inadequate Response to NUC Therapy

Start date: December 2010
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of generic entecavir monotherapy or in combination with adefovir for chronic hepatitis B patients with inadequate response to NUC therapy

NCT ID: NCT01298037 Active, not recruiting - Hepatitis B Clinical Trials

HBRN: Immune Regulation and Costimulation in Natural History of Chronic Hepatitis B

Start date: February 1, 2011
Phase:
Study type: Observational

This is an ancillary to the NIDDK-sponsored Hepatitis B Research Network (HBRN) Study Cohort Study NCT01263587. This study will examine the balance between immune regulatory and effector responses in hepatitis B-infected participants enrolled in the HBRN study (NCT01263587).

NCT ID: NCT01242787 Active, not recruiting - Chronic Hepatitis B Clinical Trials

Long-term Safety and Efficacy Study of LB80380 in the Treatment-naive Patients of Chronic Hepatitis B

LB80380
Start date: August 2010
Phase: Phase 2
Study type: Interventional

The purpose of the study is to investigate the long-term safety and the antiviral activity of the optimal doses of LB80380 for additional 48 weeks in treatment-naive patients with chronic hepatitis B infection compared to entecavir 0.5 mg.

NCT ID: NCT01172392 Active, not recruiting - Chronic Hepatitis B Clinical Trials

A Randomized Study to Assess the Loss of HbsAg After a 48-week Treatment Period With Pegylated Interferon Alpha 2a in Patients With Chronic Hepatitis B

PEGAN
Start date: January 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the loss of HbsAg after a 48-week pegylated interferon alpha 2a in patients with chronic hepatitis B (HBeAg negativation)

NCT ID: NCT01090531 Active, not recruiting - Clinical trials for Hepatitis B, Chronic

Patients With Chronic Hepatitis B and Low Viremia Not Receiving Antiviral Therapy

Start date: August 2009
Phase:
Study type: Observational

This observational long-term follow-up study will evaluate demographic, clinical, histological, biochemical, and virological parameters of patients with chronic hepatitis B and low viremia who do not require antiviral therapy according to current guidelines. Liver stiffness values as detected by FibroScan and ARFI will also be collected if available. All data will be collected at yearly intervals (minimum). Patients included in the study are followed for up to 10 years. The target sample size is <1000.