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Hepatitis B, Chronic clinical trials

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NCT ID: NCT03042481 Recruiting - Chronic Hepatitis b Clinical Trials

Off-therapy Response After Stopping Entecavir or Tenofovir

Start date: April 2016
Phase: N/A
Study type: Observational

Pegylated-interferon (Peg-IFN) α-2a, entecavir (ETV) and tenofovir disoproxil fumarate (TDF) are current recommended first-line antiviral therapies for chronic hepatitis B (CHB). Compared with Peg-IFN therapy, nucleot(s)ide analogue (NUC) therapy has the advantages of having a potent antiviral effect, and good tolerance without side effect. The long-term safety and efficacy of ETV and TDF therapy had also been identified. However, poor durability of the effectiveness after stopping NUC therapy are encountered in the majority of patients. Previous study identified a high HBV relapse rate of over 50% in HBeAg- positive CHB patients treated with lamivudine. A recent study investigating the post-treatment durability of ETV showed that higher to 45.3% of the HBeAg-negative CHB patients happened a clinical relapse within 1-year after stopping ETV therapy. TDF is another recommended first line NUC with high potency and high genetic barrier. Although the efficacy of long-term TDF therapy had been identified, there is lack of data regarding the off-therapy response in CHB patients with TDF therapy currently. Only a small scale of patients treated with TDF were included in a recent study investigating off-therapy relapse in non-cirrhotic HBeAg-negative CHB patients after greater than 4 years of NUC therapy. In addition, the factors associated with off-therapy response are also still uncertain. The investigators plan to enrolled 400 CHB patients who had received oral antiviral therapy ETV or TDF and achieved the Asia Pacific association of the study of liver (APASL) criteria of stopping NUC therapy. The aims of the study are to investigate the rate of HBV relapse including virological and clinical relapse in all and between patients with ETV and TDF therapy, and to identify the predictive factors of relapse.

NCT ID: NCT03018821 Recruiting - Clinical trials for Hepatitis B, Chronic

The Study of Two Different Chinese Traditional Medicine Treatment on Chronic Hepatitis B

Start date: January 2017
Phase: N/A
Study type: Interventional

Although the incidence of Hepatitis B has been decreased a lot recently years, there are still quite a few chronic hepatitis B patients in China. The anti-virus drugs of western medicine such as Entecavir and Tenofovir have been proved effective on decreasing the serum hepatitis B virus (HBV) level, on the other hand, Chinese materia medica showed effective on TCM syndromes of chronic hepatitis B (CHB) such as hypochondriac pain, jaundice and abdominal mass. Besides, the hepatic fibrosis could be delayed after the appropriate treatment of TCM. This study is a multicenter, randomized, open label, parallel group clinical trial to evaluate the efficacy of two different traditional Chinese medicine (TCM) herbal treatment on chronic hepatitis B.

NCT ID: NCT03013556 Recruiting - Chronic Hepatitis Clinical Trials

Study on an Optimal Antiviral Treatment in HBeAg Positive Chronic Hepatitis B Patients

Start date: November 2016
Phase: Phase 4
Study type: Interventional

The current study is a prospective, randomized, open, multi-center investigation. The aim of the study is to investigate whether the HBeAg seroconversion rate can be improved if applying combination therapy in HBeAg positive CHB patients who has achieved HBVDNA<105copies/ml,HBsAg≤5000IU/ml, ALT≥ 2ULN or Liver histology G2S2.

NCT ID: NCT02995252 Recruiting - Hepatitis C Clinical Trials

The HOPE Study: Characterizing Patients With Hepatitis B and C

Start date: December 2014
Phase:
Study type: Observational

This is an observational, longitudinal, prospective study for sample collection and evaluation for future therapy or disease progression of chronic hepatitis B and C. Participants will be seen on an annual basis with optional additional visits for up to 10 years and provide samples for research and evaluation of disease progression. In addition, there is a longitudinal sub-study for treatment of hepatitis B that will involve 2 years of treatment with tenofovir alafenamide and blood collections with optional liver biopsies.

NCT ID: NCT02991638 Recruiting - Clinical trials for Chronic Lymphocytic Leukemia

Efficacy and Safety of Ibrutinib in Patients With CLL and Other Indolent B-cell Lymphomas Who Are Chronic Hepatitis B Virus Carriers or Occult Hepatitis B Virus Carriers

Start date: November 1, 2016
Phase: Phase 3
Study type: Interventional

Efficacy and Safety of ibrutinib in patients with chronic lymphocytic leukemia and other indolent B-cell lymphomas who are chronic hepatitis B virus carriers or occult hepatitis B virus carriers

NCT ID: NCT02982837 Recruiting - Hepatitis B Clinical Trials

To Study the Effect of Adding on Pegylated Interferon (PEG-INF) Therapy for Patients Diagnosed With Chronic Hepatitis B

RC14/055
Start date: March 2015
Phase: Phase 4
Study type: Interventional

To assess whether PEG-INF (Peglyated - interferon) Add-on therapy in patients of CHB who have achieved a maintained viral suppression (HBV DNA PCR( polymerase chain reaction) <200 for last 3-6 month) with NA's can result in increased rate of HBV infection eradication (HbsAg is undetectable by serological blood testing with or without seroconversion to HBs antibody).

NCT ID: NCT02974829 Recruiting - Clinical trials for Hepatitis B, Chronic

REALM China Extension Study

Start date: May 2016
Phase: N/A
Study type: Observational

The purpose of this study is to conduct an investigator initiated observational study to continue to follow up the China subset of study participants for another 5 years after they complete participation in the REALM Study

NCT ID: NCT02973646 Recruiting - Chronic Hepatitis b Clinical Trials

Peginterferon Alfa-2b Treatment in HBeAg(+) Chronic Hepatitis b Patients Based on Interferon Gene Mutation and Receptor Detection

Start date: January 2016
Phase: Phase 4
Study type: Interventional

The study is to observe the anti-HBV therapeutic effects of peginterferon alfa-2b in chronic hepatitis b patients with e antigen positive based on the detection of interferon gene mutation (IFNA2 p.Ala120Thr) and interferon receptor (IFNAR2) detection.

NCT ID: NCT02966964 Recruiting - Clinical trials for Hepatitis; Virus, Chronic, Type B

A Clinical Trials to Evaluate the Efficacy and Safety of Tenofovir With and Without DWPUR001 in Patients With HBV

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

The patient who meets the inclusion/exclusion criteria is assigned to Test1 group or Test 2 group or control group randomly. All subjects take one pill of Viread® Tab. (Tenofovir Disoproxil Fumarate 300mg) once a day for 48 weeks. At the same time, all randomized subjects take two pills of DWPUR001 or Placebo of DWPUR001 twice a day for 48 weeks.

NCT ID: NCT02965859 Recruiting - Chronic Hepatitis B Clinical Trials

The Safety and Dose-range Study of Metacavir Enteric-coated Capsules in Patients With Chronic Hepatitis B

Start date: December 2012
Phase: Phase 2
Study type: Interventional

The study objective is to evaluate the safety and effectiveness of different doses of Metacavir Enteric-coated Capsules in treatment of chronic hepatitis B,as well as to find an appropriate clinical dosage by comparing the effect of different doses of treatment,in order to provide references of clinical trial of the next phase.