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Hepatitis B, Chronic clinical trials

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NCT ID: NCT02862548 Completed - Chronic Hepatitis B Clinical Trials

Efficacy and Safety of Tenofovir Alafenamide (TAF) Versus Tenofovir Disoproxil Fumarate (TDF)-Containing Regimens in Participants With Chronic Hepatitis B Virus (HBV) Infection and Stage 2 or Greater Chronic Kidney Disease Who Have Received a Liver Transplant

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

The primary objectives of this study are to evaluate the safety, tolerability, and efficacy of tenofovir alafenamide (TAF) versus tenofovir disoproxil fumarate (TDF)-containing regimens at Week 24 in participants with chronic hepatitis B virus (HBV) infection and Stage 2 or greater chronic kidney disease who have received a liver transplant.

NCT ID: NCT02862106 Completed - Chronic Hepatitis B Clinical Trials

Second Stage:Open-label Study of Therapeutic Hepatitis B Vaccine (Mimogen-based) for Chronic Hepatitis B

Start date: September 2010
Phase: Phase 2
Study type: Interventional

The purpose is to evaluate efficacy and safety of therapeutic HBV vaccine (mimogen-based) treatment in chronic hepatitis B patients and to explore the most effective dosage and provide the rational for optimal dosing schedule.

NCT ID: NCT02792088 Completed - Chronic Hepatitis B Clinical Trials

Study to Assess the Antiviral Activity and Safety Endpoints for the Treatment of Besifovir 150mg Compared to Tenofovir 300mg in Chronic Hepatitis B Patients Who Have Resistance to Nucleoside Analogues

HBV
Start date: July 2015
Phase: Phase 3
Study type: Interventional

To prove that a study drug is noninferior to a control drug with a proportion of subjects who showed HBV DNA undetected (less than 400 copies/mL (69 IU/mL)) at the 48th week after 48-week administration of Besifovir 150 mg, or Tenofovir 300 mg as a control drug to chronic hepatitis B patients

NCT ID: NCT02791386 Completed - Hepatitis B Clinical Trials

Rescue Treatment Pattern, Drug Resistance Recurrence, and Direct Medical Costs Associated With Chinese Patients With Chronic Hepatitis B and Drug Resistance to Nucleot(s)Ide Analogue Therapy

NAs resistance
Start date: November 22, 2016
Phase: N/A
Study type: Observational

The purpose of this study is to describe current rescue treatment pattern for nucleot(s)ide analogue (NA) resistance and assess the real-world treatment outcomes and health resources utilization of rescue treatments for drug resistance in a clinical cohort of Chinese patients with chronic hepatitis B (CHB).

NCT ID: NCT02791269 Completed - Clinical trials for Hepatitis B, Chronic

A Study of Peginterferon Alfa-2a in Participants With Chronic Hepatitis B Virus (HBV) in an Expanded Access Program

Start date: January 2006
Phase: Phase 4
Study type: Interventional

This is an expanded access, multicenter, national, open-label, and non-randomized study to analyze the safety of peginterferon alfa-2a in participants with hepatitis B e antigen (HBeAg) positive and HBeAg negative chronic HBV. All participants will receive 48 weeks treatment of peginterferon alfa-2a monotherapy, followed by a 24 week treatment-free follow-up period. Total length of the study is anticipated to be approximately 72 weeks.

NCT ID: NCT02743182 Completed - Clinical trials for Chronic Hepatitis B (HBeAg-negative)

HBsAg Loss Adding Pegylated Interferon in HBeAg-negative Patients

Start date: January 2015
Phase: N/A
Study type: Interventional

Chronic hepatitis B (CHB) affects more than 350 million people worldwide. The most common form in Europe is CHB HBeAg-negative. Antiviral treatment of CHB HBeAg-negative patients includes chronic administration of nucleos(t)ide analogues (NUC) or pegylated interferon (PegIFN) during 12 months. Typically, PegIFN allows immune control of CHB and antigen "s" (HBsAg) loss in around 4% of patients compared to less than 0,1% using NUC. Recently, it has been described that HBsAg quantification (HBsAg-q) is useful to identify patients with high probability to lose HBsAg during follow-up. In addition, a proof-of-concept study with nine HBeAg-negative patients receiving NUC showed that adding PegIFN (16 weeks) achieved HBsAg loss in one patient (11%). The aim of our study is to evaluate the efficacy and safety adding PegIFN (48 weeks) in treated HBeAg-negative patients with NUC.

NCT ID: NCT02738554 Completed - Chronic Hepatitis B Clinical Trials

Off Treatment Durability in Chronic Hepatitis B With Good Immune Control

Start date: January 2016
Phase: N/A
Study type: Interventional

Treatment cessation in chronic hepatitis B is associated with high rates of disease relapse. However patients who achieve the seroclearance of hepatitis B surface antigen (HBsAg) (<0.05 IU/mL) show good off-treatment durability after treatment cessation. Through the quantification of HBsAg, the study aims to investigate how low should quantitative HBsAg be before once can achieve successful disease control after treatment cessation.

NCT ID: NCT02726789 Completed - Clinical trials for Hepatitis B, Chronic

Combination Treatment With REP 2139-Ca and Pegasys in Patients With Chronic Hepatitis B

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

The REP 201 protocol is a small exploratory study assessing the antiviral effects and tolerability of REP 2139-Ca when used with a full course of pegylated interferon (48 weeks) in treatment naive patients or in patients already receiving entecavir and continuing entecavir with treatment.

NCT ID: NCT02693652 Completed - Clinical trials for Hepatitis B, Chronic

A Study to Evaluate the Safety and Efficacy of Therapeutic Hepatitis B Vaccine

Start date: October 28, 2014
Phase: Phase 1/Phase 2
Study type: Interventional

A single center, open labeled phase I/IIa study to evaluate safety, tolerability and efficacy of a therapeutic hepatitis B vaccine in oral antiviral drug-treated chronic hepatitis B virus carriers

NCT ID: NCT02662712 Completed - Healthy Clinical Trials

A Study of Orally Administered JNJ-56136379 to Evaluate Safety, Tolerability and Pharmacokinetics After Single Ascending Doses and One Multiple Dose Regimen in Healthy Participants (Part I), and After Multiple Dose Regimens in Participants With Chronic Hepatitis B (Part II)

Start date: December 17, 2015
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate pharmacokinetics and safety data including serious and other adverse events, physical examinations, vital signs, 12-lead electrocardiograms (ECGs) and clinical laboratory results (including biochemistry, hematology, and urine).