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Hepatitis, Chronic clinical trials

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NCT ID: NCT03604016 Not yet recruiting - Hepatitis B Clinical Trials

Study to Assess Efficacy of Besifovir and L-carnitine in Chronic Hepatitis B Patients With Nonalcoholic Fatty Liver

Start date: September 23, 2018
Phase: Phase 4
Study type: Interventional

Pilot study to assess the antiviral activity and safety of Besifovir dipivoxil 150mg and L-carnitine 660mg compared to Tenofovir Alafenamide 25mg in chronic hepatitis B patients with Nonalcoholic fatty liver

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: NCT03587467 Recruiting - Healthy Clinical Trials

Study on Gut Microbiota in Chronic HBV Infected Patients

HBV
Start date: December 1, 2017
Phase:
Study type: Observational

Hepatitis B Virus(HBV) infection 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 nomal 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. Recently, the relationship between immune response and intestinal microbiota has been claimed. In a previous study using IMT to treat HBeAg positive chronic hepatits B patients combined with antiviral theraopy, 80% of them has reached HBeAg clearance. Increasing evidence suggests that the gut microbiota has evolved as a new important player in the pathogenesis of hepatitis B virus-induced chronic liver disease. However, the composition and structure alteration of the gut microbiota associated with the stage and progression of HBV infection remains unknown. Hence, we proposed a trial to detected gut microbiota of chronic HBV infected patients high-throughput 16S rRNA gene sequencing to elucidate the microbial influence which contribute to the microbial shift of patient in different stage.

NCT ID: NCT03585322 Completed - Chronic Hepatitis B Clinical Trials

APG-1387 Study of Safety, Tolerability ,PK/PD in Patients With Chronic Hepatitis B

Start date: July 4, 2018
Phase: Phase 1
Study type: Interventional

This study is a Multiple Ascending Dose study to Explore the Tolerability, Safety and Pharmacokinetics/Pharmacodynamics of APG-1387 in Chronic Hepatitis B Patients.

NCT ID: NCT03577171 Completed - Chronic Hepatitis B Clinical Trials

A Study Evaluating ABI-H0731+ Entecavir vs Entecavir Alone for the Treatment of Viremic HBeAg-positive Participants With Chronic Hepatitis B Virus Infection (cHBV)

Start date: June 19, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine if ABI-H0731 given in combination with a standard of care (SOC) entecavir (ETV) is safe and effective in participants with chronic hepatitis B infection (cHBV)

NCT ID: NCT03576066 Completed - Chronic Hepatitis B Clinical Trials

A Study Evaluating ABI-H0731 as Adjunctive Therapy in Participants With Chronic Hepatitis B Infection

Start date: June 11, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine if ABI-H0731 given in combination with a standard of care (SOC) hepatitis B virus (HBV) nucleos(t)ide reverse transcriptase inhibitor (NUC) medication is safe and effective in participants with chronic hepatitis B virus infection (cHBV).

NCT ID: NCT03575208 Withdrawn - Chronic Hepatitis B Clinical Trials

Hepatitis B Immune Globulin (HBIg) to Restore Immune Control in People With Chronic Hepatitis B

Start date: February 13, 2019
Phase: Phase 2
Study type: Interventional

Background: Hepatitis B is a viral infection of the liver. When the immune system tries to clear hepatitis B, it damages the liver. Eventually, the immune system gets exhausted fighting the virus. Researchers want to see if giving large doses of an antibody (HBIg) with the drug peginterferon will boost the immune system in people with this disease. Objectives: To observe the effect of large doses of antibody against the hepatitis B surface antigen on the immune response to the virus. To see if removing hepatitis B surface antigen from the blood enhances the action of peginterferon. Eligibility: Adults ages 18 and older with hepatitis B Design: Participants will be screened twice with a medical history, physical exam, and blood and urine tests. Participants will be randomly put in one of two groups. All participants will get peginterferon for 24 weeks. One group will first get HBIg for 12 weeks. Participants in the combination group will have a 4-day clinic stay. They will have: Repeats of screening tests Eye exam Liver ultrasound The first dose of HBIg by IV over 2 hours These participants will get HBIg at the clinic up to 8 times over 12 weeks then start the peginterferon. All participants will get peginterferon for 24 weeks. They will get it by injection under the skin once a week. They may do this themselves. They will keep a drug diary. They will have 5 visits to assess response and monitoring for safety.. After stopping the study drug, participants will have 4 follow-up visits over 36 weeks. They will repeat screening tests and have 1 liver ultrasound.

NCT ID: NCT03566030 Not yet recruiting - Hepatitis B Clinical Trials

Switching From Tenofovir Disoproxi Fumarate to Tenofovir Alafenamide in Chronic Hepatitis B Patients With Antiviral Resistance

Start date: September 1, 2018
Phase:
Study type: Observational

- To evaluate the efficacy of switching to tenofovir alafenamide (TAF) 25 mg QD versus continued tenofovir disoproxil fumarate (TDF) 300 mg QD in CHB patients with antiviral resistance, as determined by the proportion of virologically suppressed patients at week 48 - To evaluate the safety and tolerability of switching to TAF 25 mg QD versus continuing TDF 300 mg QD in antiviral-resistant subjects with chronic HBV at week 48

NCT ID: NCT03559790 Recruiting - Chronic Hepatitis b Clinical Trials

Treatment Efficacy and Safety of TDF-TAF Switch Study in South Korea

Start date: July 18, 2018
Phase:
Study type: Observational

Recent TAF has introduced to have more safe profiles than TDF in clinical trials. Especially, TDF has the renal safety issue in high risk group including HIV, decompensated cirrhosis (ascites), uncontrolled DM etc. However, there is no available cohort data for treatment efficacy and safety in TDF-TAF switch therapy in treatment-naïve chronic hepatitis B. The aim of this study is to evaluate safety and efficacy of TAF switch therapy in patients with chronic hepatitis B who have been treated with TDF.

NCT ID: NCT03546621 Completed - Clinical trials for Chronic Hepatitis D Infection With Hepatitis B

A Multicenter, Open-label, Randomized Clinical Study to Assess Efficacy and Safety of 3 Doses of Myrcludex B for 24 Weeks in Combination With Tenofovir Compared to Tenofovir Alone to Suppress HBV Replication in Patients With Chronic Hepatitis D

Start date: February 16, 2016
Phase: Phase 2
Study type: Interventional

This is a multicenter, open-label, randomized clinical trial to Assess Efficacy and Safety of 3 Doses of Myrcludex B for 24 Weeks in Combination with Tenofovir Compared to Tenofovir Alone to Suppress HBV Replication in Patients with Chronic Hepatitis D