Hepatitis B
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CLINICAL_TRIALS trial_result · 2023-02-21Clinical Trial Update: 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 [Phase 3]
Phase 3 trial comparing besifovir 150mg to tenofovir 300mg in chronic hepatitis B patients with nucleoside analogue resistance has completed…
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CLINICAL_TRIALS trial_result · 2023-02-17Clinical Trial Update: A Study of ABI-H0731 + Nucleos(t)Ide as Finite Treatment for Chronic Hepatitis B Patients [Phase 2]
Phase 2 trial of ABI-H0731 plus nucleos(t)ide as finite treatment for chronic hepatitis B was terminated; results posted.
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CLINICAL_TRIALS trial_result · 2023-02-06Clinical Trial Update: Tenofovir in Early Pregnancy to Prevent Mother-to-child Transmission of Hepatitis B Virus [Phase 1, Phase 2]
Clinical trial update on using tenofovir in early pregnancy to prevent mother-to-child transmission of hepatitis B virus; phases completed.
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CLINICAL_TRIALS trial_result · 2023-01-31Clinical Trial Update: Study of the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics of PA1010 in HBV Patients [Phase 1, Phase 2]
Phase 1/2 trial update evaluating safety, tolerability, PK and PD of PA1010 in chronic HBV infection has completed.
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FDA approval · 2022-12-14FDA Approved: VEMLIDY — Supplemental Application (Gilead Sciences, Inc.)
The FDA approved a supplemental application for Vemlidy (tenofovir alafenamide) from Gilead Sciences. This action updates the regulatory sta…
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CLINICAL_TRIALS trial_result · 2022-11-17Clinical Trial Update: An Efficacy, Safety, and Pharmacokinetics Study of JNJ-56136379 in Participants With Chronic Hepatitis B Virus Infection [Phase 2]
Phase 2 trial evaluating efficacy, safety, and pharmacokinetics of JNJ-56136379 in chronic hepatitis B patients has completed with posted re…
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CLINICAL_TRIALS trial_result · 2022-11-10Clinical Trial Update: Efficacy and Safety of Avatrombopag for Treating TCP in HBV-ACLF Patients Receiving ALSS Treatment [Phase 4]
Phase 4 clinical trial investigating the efficacy and safety of avatrombopag for thrombocytopenia in patients with HBV-related acute-on-chro…
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CLINICAL_TRIALS trial_result · 2022-10-31Clinical Trial Update: Pegylated Interferon(Peg-IFN) in Reducing Relapse Rate in Patients After Discontinuation of NUC Therapy [Phase 4]
Phase 4 trial investigating pegylated interferon to reduce relapse after stopping nucleos(t)ide therapy in chronic hepatitis B patients.
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CLINICAL_TRIALS trial_result · 2022-10-20Clinical Trial Update: A Study Evaluating Treatment Intensification With ABI-H0731 in Participants With Chronic Hepatitis B Infection on Nucleos(t)Ide Reverse Transcriptase Inhibitors [Phase 2]
Phase 2 trial evaluating treatment intensification with ABI-H0731 in chronic hepatitis B patients on nucleos(t)ide reverse transcriptase inh…
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FDA approval · 2022-10-17FDA Approved: VEMLIDY — Supplemental Application (Gilead Sciences, Inc.)
FDA approved a supplemental application for Vemlidy (tenofovir alafenamide) from Gilead Sciences. The action pertains to updating the produc…
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CLINICAL_TRIALS trial_result · 2022-10-12Clinical Trial Update: Combination Therapy of Pegylated Interferon Alfa-2a and Tenofovir Versus Tenofovir Monotherapy in Chronic Hepatitis B [Phase 3]
Phase 3 trial comparing pegylated interferon alfa-2a plus tenofovir versus tenofovir alone in chronic hepatitis B has completed with results…
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CLINICAL_TRIALS trial_result · 2022-10-12Clinical Trial Update: Study of EYP001a to Assess Its Safety and Anti-viral Effect in CHB Patients in Combination With NA (ETV or TD) [Phase 2]
Phase 2 study evaluating EYP001a with nucleos(t)ide analogs in chronic hepatitis B; study terminated with posted results.
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CLINICAL_TRIALS trial_result · 2022-09-29Clinical Trial Update: A Pilot Study Comparing the Immunogenicity of Fendrix vs. Double-dose Engerix B in HIV-infected Non-responders to Standard Hepatitis B Vaccination Courses [Phase 2, Phase 3]
A pilot Phase 2/3 trial comparing immunogenicity of Fendrix versus double-dose Engerix B in HIV-infected non-responders to standard Hepatiti…
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CLINICAL_TRIALS trial_result · 2022-09-19Clinical Trial Update: Protectivity and Safety Following Recombinant Hepatitis B Vaccine [Phase 2, Phase 3]
Phase 2/3 clinical trial update on recombinant Hepatitis B vaccine focusing on immunogenicity and safety.
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CLINICAL_TRIALS trial_result · 2022-08-26Clinical Trial Update: A Study of ABI-H2158-containing Regimens in Participants With Chronic Hepatitis B Virus Infection [Phase 2]
Phase 2 trial update for regimens containing ABI-H2158 in chronic hepatitis B; study terminated with results posted.
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CLINICAL_TRIALS trial_result · 2022-08-25Clinical Trial Update: A Study of the Oral Farnesoid X Receptor Modulator EYP001a to Assess Its Safety and Anti-viral Effect in Chronic Hepatitis B Patients in Combination With Pegylated Interferon alpha2a Alone and With Entecavir [Phase 2]
Phase 2 study evaluating safety and antiviral effect of oral FXR modulator EYP001a in chronic hepatitis B, in combination with pegylated int…
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CLINICAL_TRIALS trial_result · 2022-08-03Clinical Trial Update: Safety and Efficacy of Celecoxib Plus Nucleos(t)Ide Analogues on the Hepatitis B Surface Antigen of Virally Suppressed Subjects With Chronic Hepatitis B [Phase 2]
Phase 2 trial updating safety and efficacy of combining celecoxib with nucleos(t)ide analogues in nucleoside-treated chronic hepatitis B pat…
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CLINICAL_TRIALS trial_result · 2022-08-02Clinical Trial Update: Atorvastatin Use and Portal Hypertension in Patients With Hepatitis B Virus-related Liver Cirrhosis: A Randomized Controlled Trial [Phase 2]
A Phase 2 randomized trial evaluating atorvastatin use in patients with hepatitis B virus-related liver cirrhosis and portal hypertension.
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CLINICAL_TRIALS trial_result · 2022-07-26Clinical Trial Update: Effects of Pioglitazone and Evogliptin on Hepatic Fibrosis in Patients With Chronic Hepatitis B With Type 2 Diabetes [Phase 4]
Phase 4 trial exploring the effects of pioglitazone and evogliptin on hepatic fibrosis in patients with chronic hepatitis B and type 2 diabe…
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CLINICAL_TRIALS trial_result · 2022-07-25Clinical Trial Update: Safety and Immunogenicity of Recombinant Hepatitis B Vaccine Sci-B-Vac® Compared to Engerix-B® [Phase 3]
Phase 3 trial comparing Sci-B-Vac to Engerix-B for safety and immunogenicity in Hepatitis B was completed with results posted in 2022.
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CLINICAL_TRIALS trial_result · 2022-07-20Clinical Trial Update: Demonstration Project on Health Care Worker Protection Against Hepatitis B in Kalulushi District [Phase 4]
Phase 4 demonstration project assessing health care worker protection against Hepatitis B in Kalulushi District has completed.
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CLINICAL_TRIALS trial_result · 2022-06-24Clinical Trial Update: A Bridging Study: Comparing Two Lots of Sci-B-Vac™ and Engerix-B in Healthy Adults [Phase 3]
Phase 3 bridging study comparing two lots of Sci-B-Vac and Engerix-B in healthy adults has completed with results posted.
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CLINICAL_TRIALS trial_result · 2022-06-24Clinical Trial Update: A Study to Qualify an In-house Reference Standard Batch of Sci-B-Vac™ [Phase 4]
Phase 4 trial updating qualification of an in-house reference standard batch for Sci-B-Vac, with Hepatitis B as the indication.
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CLINICAL_TRIALS trial_result · 2022-06-23Clinical Trial Update: A Phase II Clinical Trial of Hydronidone Capsules(F351) in Patients With Liver Fibrosis Induced by HBV Chronic Hepatitis [Phase 2]
Phase II trial completed evaluating Hydronidone capsules (F351) for liver fibrosis due to chronic Hepatitis B infection.
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CLINICAL_TRIALS trial_result · 2022-06-09Clinical Trial Update: Evaluate the Efficacy and Safety to Tenofovir Disoproxil in Chronic Hepatitis B Patients [Phase 4]
Phase 4 trial update evaluating the efficacy and safety of Tenofovir Disoproxil in adults with chronic hepatitis B.