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Hepatitis, Chronic clinical trials

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NCT ID: NCT04412863 Active, not recruiting - Chronic Hepatitis B Clinical Trials

Study of VIR-2218 With or Without Pegylated Interferon Alpha-2a for Treatment of Chronic Hepatitis B Virus Infection

Start date: July 3, 2020
Phase: Phase 2
Study type: Interventional

This is a phase 2 study in which subjects with chronic hepatitis B virus (HBV) infection will receive VIR-2218 alone or in combination with pegylated interferon alfa-2a and will be assessed for safety, tolerability, pharmacokinetics, and antiviral activity.

NCT ID: NCT04069858 Active, not recruiting - Chronic Hepatitis B Clinical Trials

Maintaining Antiviral Efficacy After Switching to Generic Entecavir 1 mg for Chronic Hepatitis B

Start date: December 1, 2016
Phase: Phase 4
Study type: Interventional

Entecavir 1 mg is commonly used in patients with chronic hepatitis B (CHB) patients with previous antiviral resistance. This study evaluates the efficacy and safety of switching to generic entecavir 1 mg (Baracle®, Dong-A Science Technology) in CHB patients taking brand name entecavir 1 mg (Baraclude®, Bristol-Myers Squibb) alone or in combination with other nucleos(t)ide analogues after the development of antiviral resistance. The primary aim is virological response (<20 IU/mL) at 12 months

NCT ID: NCT03993925 Active, not recruiting - Chronic Hepatitis C Clinical Trials

Enhancing Access to Care for Chronic Hepatitis C Infected Populations in Hong Kong

Start date: September 20, 2019
Phase:
Study type: Observational

In the current era of highly effective direct acting antiviral (DAA) therapy, the remaining obstacles to elimination of chronic HCV infection are identification of the high-risk groups, linkage to continued care and prevention of re-infection. It is estimated that 70-80% of patients with chronic HCV are unaware of their infection. Besides, public health education is limited and most patients are not aware that the current standard-of-care is highly effective, well tolerated and no longer require weekly subcutaneous injections. From a survey in Hong Kong in 2014, among 234 newly diagnosed HCV patients, only 20% agreed to undergo treatment. There is no universal screening programme for chronic hepatitis C infection in Hong Kong. and known high-risk patients include people who inject drugs (PWID), persons with certain medical conditions including those on hemodialysis, HIV infected, those with prior transfusion or organ transplantation. In this study, the investigators plan to reach out to PWIDs, people with substance abuse or prison inmates to provide rapid point-of-care screening for chronic hepatitis C infection, and to provide linkage to care for those diagnosed with chronic hepatitis C.

NCT ID: NCT03852719 Active, not recruiting - Clinical trials for Chronic Hepatitis Delta

Study to Assess Efficacy and Safety of Bulevirtide in Participants With Chronic Hepatitis Delta (CHD)

Start date: April 17, 2019
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate the efficacy of bulevirtide for treatment of chronic hepatitis delta (CHD) in comparison to delayed treatment.

NCT ID: NCT03801798 Active, not recruiting - Hepatitis B Clinical Trials

A Study of GC1102(Recombinant Hepatitis B Immunoglobulin) in Chronic Hepatitis B Patients

Start date: February 11, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of GC1102 in combination of Nucleo(t)ide analogues (NAs) in patients with chronic hepatitis B

NCT ID: NCT03801538 Active, not recruiting - Chronic Hepatitis B Clinical Trials

The Optimizing Treatment of Peginterferon Alpha in Chronic Hepatitis B Patients With Low Level HBsAg

Start date: January 1, 2019
Phase: Phase 4
Study type: Interventional

HBeAg-negative chronic hepatitis B (CHB) patients with low Level HBsAg were enrolled. After giving informed consent, patients were treated with nucleoside analog(s) (NAs) once a day and weekly subcutaneous injections of peginterferon alfa-2a 180 micrograms/week or peginterferon alfa-2b 180 micrograms/week for 12 weeks. At week 12, the decrease of HBsAg was evaluated. ①If the decrease of HBsAg is more than 50% compared to baseline level. NAs was stopped, patients were treated with weekly subcutaneous injections of alfa-2a 180 micrograms/week or peginterferon alfa-2b 180 micrograms/week. Treatment endpoint was HBsAg loss(<0.05 IU/ mL). Depending on the decline of HBsAg level, treatment was either continued for a prolonged period (no more than 96 weeks) until the endpoint was achieved, or terminated in week 96. After treatment, all patients were followed up for 48 weeks. ②If the decrease of HBsAg is less than 50% compared to baseline level. The combination therapy of NAs and peginterferon alfa was extended to week 24. Then, the decrease of HBsAg was evaluated again. If the decrease of HBsAg is more than 50% compared to baseline level. NAs was stopped, patients were treated with weekly subcutaneous injections of alfa-2a 180 micrograms/week or peginterferon alfa-2b 180 micrograms/week. Treatment endpoint was HBsAg loss(<0.05 IU/mL). Depending on the decline of HBsAg level, treatment was either continued for a prolonged period (no more than 96 weeks) until the endpoint was achieved, or terminated in week 96. After treatment, all patients were followed up for 48 weeks. If the decrease of HBsAg is less than 50% compared to baseline level. Peginterferon alfa was stopped, patients were treated with NAs once a day and then followed up for 48 weeks. Patients who maintained the original NAs treatment served as a control group.

NCT ID: NCT03777969 Active, not recruiting - Chronic Hepatitis b Clinical Trials

Prediction System of Clinical Endpoint Events for Chronic Hepatitis B Patients

Start date: June 29, 2018
Phase:
Study type: Observational

A total of 2000 chronic hepatitis B (CHB) patients with liver biopsy performed at least 1 year after antiviral therapy are enrolled. All the patients will receive original antiviral treatment for the following 10 years. Patients will be assessed at baseline and at every six months for blood count, liver function test, alpha fetoprotein (AFP), prothrombin time, liver ultrasonography, liver stiffness measurement (LSM), Hepatitis B virus (HBV) DNA and HBV serological markers. HBV-related endpoint events, including cirrhosis decompensations (ascites, esophageal variceal bleeding and hepatic encephalopathy), hepatocellular carcinoma (HCC), liver transplantation and liver-related death, will be collected during follow-up.

NCT ID: NCT03740789 Active, not recruiting - Chronic Hepatitis b Clinical Trials

Evaluation of Antiviral Indications on Chronic HBV Infection With Different Transaminase Levels

Start date: October 24, 2018
Phase:
Study type: Observational

It remains unknown whether antiviral therapy is beneficial for chronic hepatitis B (CHB) with normal or mild ALT.The investigators aim to evaluate the antiviral indications combining liver biopsy and clinical parameters,and further clarify the response indexes of clinical results such as virological, serological, biochemical and histological responses from a retrospective observational cohort study on antiviral therapy in HBeAg positive and negative patients with different ALT levels,especially when ALT lower 2 times upper limit of normal (ULN).

NCT ID: NCT03597633 Active, not recruiting - Clinical trials for Chronic Hepatitis b With Multidrug Resistance

Tenofovir Combination or Mono-therapy for MDR CHB

Start date: June 1, 2013
Phase:
Study type: Observational [Patient Registry]

Treatment of multidrug resistant (MDR) chronic hepatitis B (CHB) is still a challenging issue. Hence, the investigators will perform a multicenter prospective cohort study for the evaluation of tenofovir disoproxil fumarate (TDF)-based therapy for MDR CHB at real life settings.

NCT ID: NCT03539016 Active, not recruiting - Clinical trials for Hepatitis B, Chronic

Observational Study on Pregnant Women With Chronic Hepatitis B and Their Infants

Start date: July 2015
Phase:
Study type: Observational

The study was conducted to observe the clinical features during pregnancy in women with chronic hepatitis B virus infection and mother-to-child transmission of hepatitis B virus.