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Chronic Hepatitis B clinical trials

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NCT ID: NCT03448744 Recruiting - Chronic Hepatitis b Clinical Trials

Efficacy and Safety of Combination Therapy of Thymalfasin and Entecavir in HBeAg-positive ETV-experienced Patients

Start date: October 25, 2017
Phase: Phase 4
Study type: Interventional

This is a multicenter, randomized, open-label control trial of two arms conducted at 10 centres in China.The aim was to investigate whether sequential combination therapy with Thymosin alpha 1 and entecavir is superior to continuous ETV monotherapy in HBeAg-positive chronic hepatitis B patients with previous long-term entecavir therapy (≥ 2 years), and to select the optimal patients who may benefit from sequential combination therapy.

NCT ID: NCT03429439 Recruiting - Chronic Hepatitis b Clinical Trials

Study on Effect of Intestinal Microbiota Transplantation in Chronic Hepatitis B

CHB
Start date: December 29, 2017
Phase: N/A
Study type: Interventional

Chronic hepatitis B(CHB) is a common infectious disease affecting up to 2 billion people worldwide. Around 650 thousand people died of liver failure, cirrhosis and primary liver cancer caused by chronic hepatitis B every year. Age is the main factor affecting the chronicity of hepatitis B, while 90% and 25% to 30% of hepatitis b virus(HBV) infection in perinatal and infant period will develop into chronic infection respectively. Whereas the proportion in patients above 5 years old is only 5% to 10%. Intestinal microbiota plays an important role in maintaining normal physiological function of the intestine and the immune function of the body. It has been found that the disorder of intestinal microbiota is associated with numerous intestinal and parenteral diseases. Intestinal microbiota transplantation(IMT) is a significant method to reconstruct intestinal flora. Recently, the relationship between immune response and intestinal microbiota has been claimed. In a previous study using IMT to treat HBeAg positive chronic hepatitis B patients combined with antiviral therapy, 80% of them has reached HBeAg clearance. The investigators propose a randomised trial of IMT in patients with chronic hepatitis B combined with antiviral therapy. The investigators will assess the serum HBsAg, anti-HBs, HBeAg, anti-HBe, anti-hepatitis B core antigen, the relief of gastrointestinal symptoms, and the fecal microbiota before and after IMT. Patients will be randomized to either antiviral therapy or IMT combined antiviral therapy over a 26 weeks period.

NCT ID: NCT03405597 Recruiting - Clinical trials for Chronic Hepatitis B, HBsAg, Hepatitis B Vaccine

HBsAb Response After HBV Vaccination in Chronic Hepatitis B Patients Who Have Lost HBsAg

Start date: March 30, 2017
Phase: Phase 3
Study type: Interventional

Chronic HBV infection is major problem in Asian countries. Years after chronic infection, in some cases serum HBsAg level declines to unmeasurable level. Some of patients develop anti-HBsAb but there is no standard treatment to accelerate HBsAg seroconversion. There is a study to determine efficacy and safety of HBV vaccine in who is Chronic HBV infection and lost their HBsAg without seroconversion to anti-HBsAb.

NCT ID: NCT03357822 Recruiting - Chronic Hepatitis B Clinical Trials

A Real-World Study of Pegylated Interferon In Nucleoside-treated Patients With Chronic Hepatitis B

COST
Start date: January 25, 2018
Phase: Phase 4
Study type: Interventional

The aim of the prospective real-world study is to evaluate whether sequential combination therapy with pegylated interferon plus entecavir/tenofovir could induce higher rates of HBsAg loss in nucleoside-treated patients with chronic hepatitis B compared to continuous nucleoside treatment.

NCT ID: NCT03356834 Recruiting - Chronic Hepatitis B Clinical Trials

Change of Renal Function and Bone Mineral Density in CHB Patients Switch From TDF to TAF vs. Maintaining TDF

SWITAF
Start date: December 1, 2017
Phase: Phase 4
Study type: Interventional

In Chronic hepatitis B (CHB) patients receiving long-term sequential Neucleos(t)ides(NAs), majority of these CHB patients experienced drug resistance and switched to Tenofovir disoproxil fumaratate(TDF). However, some of patients on long term TDF experienced impairment of renal function and bone mineral density. After Tenofovir alafenamide(TAF) was in clinical practice, these group of patients got an clinical option to switch from TDF to TAF. The investigators designed a prospective cohort study to evaluate the real life effectiveness and safety in participants with chronic HBV infection switch from TDF to TAF vs. maintaining on TDF.

NCT ID: NCT03253250 Recruiting - Chronic Hepatitis b Clinical Trials

The Investigation of Peginterferon Alfa-2a on the RFS of the Subjects With HCC Who Have Been Treated by Resection

Start date: September 1, 2017
Phase: Phase 4
Study type: Interventional

The current study is a prospective, randomized, open, multi-center investigation. The aim of current study is to investigate whether the Recurrence-free Survival Rate (RFS)of the hepatitis B related -hepatocellular carcinoma subjects who have been treated by resection can be improved by peginterferon alfa-2a

NCT ID: NCT03244085 Recruiting - Chronic Hepatitis b Clinical Trials

A Study to Investigate the Safety, Efficacy and Pharmacokinetic Profile of Multiple Doses of QL-007 in Chronic Hepatitis B Patients

Start date: August 20, 2017
Phase: Phase 1
Study type: Interventional

This is a nonrandomized, open-label, no-control, dose-escalation Phase 1b trial in 18 patients with chronic HBV infection to determine the safety, preliminary efficacy, and pharmacokinetics (PK) of QL-007 after administration over 28 days of multiple oral doses in a fasted state at the following planned dose levels: 200 mg/day (100 mg two times a day (BID)), 400 mg/day (200 mg BID), then 600 mg once daily (QD), with 6 patients for each cohort.

NCT ID: NCT03214302 Recruiting - Chronic Hepatitis B Clinical Trials

The Incidence of Postpartum Hepatitis in Pregnant Women With Chronic Hepatitis B Virus Infection

Start date: January 1, 2017
Phase: N/A
Study type: Interventional

The majority of childbearing age women with hepatitis B virus infection were still in the immune tolerance period. Our recent research had shown that most puerperae after delivery had elevated ALT level. However, there is no withdrawal time recommendations after childbirth at present.Through the study of hepatitis occurrence after delivery and drug withdrawal, the investigators explore the withdrawal time of antiviral treatment during pregnancy.

NCT ID: NCT03209908 Recruiting - Chronic Hepatitis B Clinical Trials

The Study of Short-range Antiviral Treatment During Pregnancy to Block Mother-to-child Transmission of Hepatitis B Virus and Withdrawal Time

Start date: January 1, 2017
Phase: N/A
Study type: Observational

Pregnant women carry high HBV DNA loads before delivery, which is the most important factor leading to mother-to-child transmission of HBV. Nucleoside analogue antiviral treatment during late pregnancy can significantly reduce the incidence of HBV MTCT, but security problems of using NA treatment during pregnancy has not been eliminated, Therefore, the aim of our study is to explore the effect of starting to use Tenofovir Disoproxil Fumarate(TDF) antiviral treatment from the 32 weeks of gestation to block mother-to-child transmission of hepatitis B virus(HBV MTCT).

NCT ID: NCT03108794 Recruiting - Chronic Hepatitis B Clinical Trials

A Nation-wide Hospital-based Hepatitis B Registry:China Registry of Hepatitis B

Start date: June 30, 2012
Phase: N/A
Study type: Observational [Patient Registry]

CR-HepB registry started in June 30,2012 to collect HBV cases from general hospitals or specialized hospitals for infectious diseases in mainland China. Demographics, diagnosis, laboratory test results, family history and prescriptions were recorded. The main criteria for registration is HBsAg-positivity more than 6 months, and these patients will receive followed-up visits every three to six months.