Hepatitis B
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CLINICAL_TRIALS trial_result · 2025-01-27Clinical Trial Update: A Phase II Study of Hepalatide in Subjects With Chronic Hepatitis B [Phase 2]
The document reports the completion status of a Phase II study evaluating Hepalatide in adults with chronic hepatitis B.
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CLINICAL_TRIALS trial_result · 2025-01-22Clinical Trial Update: Pharmacokinetics (PK) of Tipranavir/Ritonavir, Ribavirin, Pegylated Interferon (Peg INF) in Hepatitis C (HCV) Subjects With Mild Hepatic Impairment and in HCV, Hepatitis B (HBV), Hepatitis D Infected Subjects or Alcoholic Cirrhosis With Moderate Hepatic Impairment [Phase 1]
Phase 1 pharmacokinetic study evaluating tipranavir/ritonavir, ribavirin, and pegylated interferon in subjects with mild hepatic impairment …
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CLINICAL_TRIALS trial_result · 2025-01-20Clinical Trial Update: Cameroon Baptist Convention Health Board Chronic Hepatitis B Cohort Study
Clinical trial update indicating that the Cameroon Baptist Convention Health Board Chronic Hepatitis B Cohort Study sponsored by Mayo Clinic…
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CLINICAL_TRIALS research · 2025-01-17Clinical Trial Update: Molecular Characteristics of Hepatitis B Virus Integration, Mutation, and Drug Resistance
This clinical trial update examines the molecular characteristics of hepatitis B virus integration, mutation, and drug resistance in chronic…
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CLINICAL_TRIALS research · 2025-01-15Clinical Trial Update: Clinical Study of Antiviral Therapy Combined With Novel Immunotherapy for CHB in Adults [NA]
This clinical trial update describes an ongoing study evaluating a combination of antiviral therapy with a novel immunotherapy for chronic h…
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EMA withdrawal · 2025-01-10EMA Withdrawn: PreHevbri (hepatitis B surface antigen) — VBI Vaccines B.V.
The EMA has withdrawn the marketing authorization for PreHevbri (hepatitis B surface antigen) from VBI Vaccines B.V.
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CLINICAL_TRIALS trial_result · 2025-01-09Clinical Trial Update: Tenofovir Alafenamide Switching Therapy in Kidney or Liver Transplant Recipients With Chronic HBV Infection [Phase 4]
Phase 4 clinical trial update evaluating switching kidney or liver transplant recipients with chronic hepatitis B to Tenofovir alafenamide t…
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CLINICAL_TRIALS research · 2025-01-09Clinical Trial Update: Tenofovir Alafenamide Versus Entecavir for the Treatment of Chronic Hepatitis B [Phase 4]
Phase 4 clinical trial comparing Tenofovir alafenamide versus Entecavir for chronic hepatitis B is currently recruiting.
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CLINICAL_TRIALS research · 2025-01-09Clinical Trial Update: Tenofovir Alafenamide Switch Therapy in Chronic Hepatitis B
A recruiting clinical trial is evaluating switching patients with chronic hepatitis B to Tenofovir Alafenamide, focusing on adherence, satis…
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CLINICAL_TRIALS research · 2024-12-30Clinical Trial Update: Study to Investigate the Efficacy and Safety of Regimens Containing BRII-179, BRII-835, and PEG-IFNα Treating Chronic Hepatitis B Virus (HBV) Infection (ENRICH) [Phase 2]
Phase 2 ENRICH trial evaluating regimens containing BRII-179, BRII-835, and PEG-IFNα for chronic hepatitis B; the study is currently active …
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CLINICAL_TRIALS trial_result · 2024-12-24Clinical Trial Update: This is a Phase 1 Study in Which Healthy Volunteers and Participants with Chronic HBV Infection Will Receive HT-101 or Placebo and Will Be Assessed for Safety, Tolerability, Pharmacokinetics (PK), and Antiviral Activity [Phase 1]
A Phase 1 trial comparing HT-101 to placebo in healthy volunteers and adults with chronic hepatitis B to evaluate safety, tolerability, phar…
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CLINICAL_TRIALS research · 2024-12-24Clinical Trial Update: Study on the Treatment of Hepatitis B Virus(HBV) Infected Individuals With Peginterferon α-2b Combined With NA.
This document describes an ongoing clinical trial assessing peginterferon alfa-2b in combination with a nucleos(t)ide analog to treat hepati…
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CLINICAL_TRIALS research · 2024-12-24Clinical Trial Update: An Exploratory Clinical Study Evaluating EPI-003 Injection for the Treatment of Chronic Hepatitis B [EARLY_Phase 1]
An exploratory early-phase clinical study is evaluating EPI-003 Injection for chronic hepatitis B, with the trial status listed as not yet r…
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FDA approval · 2024-12-23FDA Approved: ENTECAVIR — Supplemental Application (Carlsbad Technology, Inc.)
FDA approved a supplemental application for entecavir (ENTECAVIR) submitted by Carlsbad Technology, Inc.
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FDA approval · 2024-12-23FDA Approved: ENTECAVIR — Original Application (Epic Pharma, LLC)
FDA approved Epic Pharma, LLC's original application for entecavir, a generic version of Baraclude, for the treatment of chronic hepatitis B…
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CLINICAL_TRIALS trial_result · 2024-12-20Clinical Trial Update: Hydronidone for the Treatment of Liver Fibrosis Associated with Chronic Viral Hepatitis B Phase 3 Trial. [Phase 3]
A Phase 3 trial evaluating Hydronidone for liver fibrosis associated with chronic hepatitis B has completed.
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CLINICAL_TRIALS trial_result · 2024-12-20Clinical Trial Update: Phase 1 Study of HT-102 Administered Subcustaneously in Healthy Participants and Patients with Chronic Hepatitis B for Safety, Tolerability, Pharmacokinetics (PK), and Antiviral Activity (only in Participants with Chronic HBV Infection) [Phase 1]
Phase 1 study of HT-102 administered subcutaneously in healthy participants and chronic hepatitis B patients to evaluate safety, tolerabilit…
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FDA approval · 2024-12-19FDA Approved: ENTECAVIR — Supplemental Application (Solco Healthcare LLC)
FDA approved a Supplemental Application for ENTECAVIR from Solco Healthcare LLC, enabling continuation of marketing and manufacturing of the…
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CLINICAL_TRIALS trial_result · 2024-12-19Clinical Trial Update: A Mechanistic Study of GSK3228836 With Fine Needle Aspiration (FNA) in Participants With Chronic Hepatitis B [Phase 2]
Phase 2 mechanistic study evaluating GSK3228836 with fine-needle aspiration in participants with chronic hepatitis B; the trial has complete…
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CLINICAL_TRIALS trial_result · 2024-12-19Clinical Trial Update: Long-term Safety and Efficacy of Tenofovir Amibufenamide in Patients With CHB [Phase 4]
Long-term safety and efficacy data for Tenofovir Amibufenamide in chronic hepatitis B from a Phase 4 trial, currently active but not recruit…
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CLINICAL_TRIALS trial_result · 2024-12-17Clinical Trial Update: Study of the Efficacy and Safety of HS-10234 in Patients With Chronic Hepatitis B Virus Infection [Phase 3]
This clinical trial update reports the completion of a Phase 3 study evaluating the efficacy and safety of HS-10234 in patients with chronic…
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CLINICAL_TRIALS trial_result · 2024-12-17Clinical Trial Update: Effectiveness of TAF in Reducing Clinical Events in CHB Patients Beyond Treatment Indications by Current Guidelines [Phase 4]
Phase 4 trial update evaluating whether tenofovir alafenamide reduces clinical events in chronic hepatitis B patients beyond current guideli…
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CLINICAL_TRIALS research · 2024-12-12Clinical Trial Update: Real World Assessment of People Living With Chronic Hepatitis B in Australia
Real-world observational study update assessing people living with chronic hepatitis B in Australia; the study is currently recruiting.
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CLINICAL_TRIALS research · 2024-12-11Clinical Trial Update: Occult Hepatitis B Virus Infection and HBV Reactivation After Switching to Long Acting Therapy in Patients With HIV-1
A clinical trial evaluating occult hepatitis B infection and HBV reactivation after switching to long-acting therapy in people with HIV-1; t…
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CLINICAL_TRIALS research · 2024-12-06Clinical Trial Update: A Single and Repeated Dose Escalation of RBD1016 in Subjects with Chronic Hepatitis B Virus (HBV) Infection [Phase 1]
This document provides a Phase 1 trial update on the single and repeated dose escalation of RBD1016 in subjects with chronic hepatitis B. Th…