Hepatitis B
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CLINICAL_TRIALS trial_result · 2023-11-18Clinical Trial Update: A Study to Evaluate the Safety and Efficacy of Therapeutic Hepatitis B Vaccine [Phase 1, Phase 2]
A clinical trial evaluating the safety and efficacy of a therapeutic hepatitis B vaccine in chronic hepatitis B patients has completed Phase…
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CLINICAL_TRIALS trial_result · 2023-11-18Clinical Trial Update: A Study to Provide a Better Understanding of Baraclude's Pharmacokinetic Properties in a Real World Clinical Setting [Phase 1]
Phase 1 pharmacokinetic study of Baraclude (entecavir) in real-world setting to understand PK properties in hepatitis B patients.
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CLINICAL_TRIALS trial_result · 2023-11-14Clinical Trial Update: A Study Evaluating Treatment Regimens Containing Vebicorvir (ABI-H0731) in Participants With Chronic Hepatitis B Infection [Phase 2]
Phase 2 trial investigating regimens containing Vebicorvir (ABI-H0731) in chronic hepatitis B; the study status is terminated with results p…
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CLINICAL_TRIALS trial_result · 2023-11-08Clinical Trial Update: A Phase Ic/IIb Study to Evaluate the Efficacy，Safety and Pharmacokinetics of HST in Patients With CHB [Phase 1, Phase 2]
Clinical trial update for a Phase Ic/IIb study evaluating HST in patients with chronic hepatitis B; details on efficacy, safety, and pharmac…
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CLINICAL_TRIALS trial_result · 2023-11-07Clinical Trial Update: Study of Nitazoxanide Compared to Placebo in Subjects With HBeAG-Negative Chronic Hepatitis B [Phase 2]
Phase 2 trial evaluating nitazoxanide vs placebo in HBeAg-negative chronic hepatitis B completed with results posted.
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CLINICAL_TRIALS trial_result · 2023-10-06Clinical Trial Update: A Study Evaluating ABI-H0731-containing Regimens in Chinese Participants With Chronic Hepatitis B Virus Infection [Phase 2]
A Phase 2 trial evaluating regimens containing ABI-H0731 in Chinese participants with chronic hepatitis B was terminated, with results poste…
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FDA approval · 2023-10-05FDA Approved: LAMIVUDINE — Supplemental Application (Lupin Pharmaceuticals, Inc.)
FDA approved Lupin Pharmaceuticals' supplemental application for lamivudine, resulting in an approved generic lamivudine product. Lamivudine…
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CLINICAL_TRIALS trial_result · 2023-09-28Clinical Trial Update: A Study to Evaluate the Antiviral Activity and Safety of HH-003 Injection in Subjects With HBeAg-Negative Chronic Hepatitis B Treated With Nucleos(t)Ide Reverse Transcriptase Inhibitors [Phase 2]
Phase 2 trial evaluating HH-003 injection for antiviral activity and safety in HBeAg-negative chronic hepatitis B patients already treated w…
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CLINICAL_TRIALS trial_result · 2023-09-13Clinical Trial Update: A Randomized, Double-Blind Trial of Antroquinonol in Patients With Chronic Hepatitis B [Phase 2]
Phase 2 randomized, double-blind trial evaluating antroquinonol in chronic hepatitis B has completed.
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CLINICAL_TRIALS trial_result · 2023-07-18Clinical Trial Update: B/F/TAF Switch Study for HIV-HBV Coinfection [Phase 4]
Phase 4 trial update on switching to B/F/TAF for HIV-HBV coinfection; study completed with posted results.
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CLINICAL_TRIALS trial_result · 2023-07-03Clinical Trial Update: Treatment Outcomes in Chronic Hepatitis B Patients on Sequential Therapy With Tenofovir Alafenamide (TAF) [Phase 4]
A Phase 4 clinical trial report on sequential therapy with Tenofovir Alafenamide (TAF) for patients with chronic hepatitis B, including trea…
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CLINICAL_TRIALS trial_result · 2023-06-22Clinical Trial Update: Chronic HBV Management for Asian American [NA]
A completed clinical trial update on chronic hepatitis B management in Asian American populations; results posted in 2023.
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CLINICAL_TRIALS trial_result · 2023-06-15Clinical Trial Update: A Study to Assess the Efficacy and Safety of Burfiralimab(hzVSF-v13) and OAD (Oral Antiviral Drug) [Phase 2]
Phase 2 clinical trial evaluating Burfiralimab in combination with an Oral Antiviral Drug for chronic hepatitis B; current status is unknown…
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FDA approval · 2023-06-12FDA Approved: ADEFOVIR DIPIVOXIL — Supplemental Application (Apotex Corp.)
FDA approved a supplemental application for Adefovir Dipivoxil from Apotex Corp., marking an approved change to the ANDA for this drug.
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EMA approval · 2023-05-24EMA Authorised: Fendrix (hepatitis B surface antigen) — GlaxoSmithKline Biologicals S.A.
Fendrix has been authorised for hepatitis B immunization in the European Union.
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CLINICAL_TRIALS trial_result · 2023-05-23Clinical Trial Update: Regression of Liver Fibrosis by Tenofovir Alafenamide (TAF) [Phase 4]
Phase 4 clinical trial investigating regression of liver fibrosis with Tenofovir Alafenamide (TAF) in chronic hepatitis B patients.
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CLINICAL_TRIALS trial_result · 2023-05-16Clinical Trial Update: A Study of GSK3228836 in Participants With Chronic Hepatitis B (CHB) [Phase 2]
Phase 2 trial update for GSK3228836 in chronic hepatitis B has completed with results posted.
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CLINICAL_TRIALS trial_result · 2023-05-12Clinical Trial Update: Use of TDF in Patients With Inactive Chronic Hepatitis B Infection [Phase 3]
A Phase 3 trial evaluating tenofovir disoproxil fumarate (TDF) in patients with inactive chronic hepatitis B; study completed.
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CLINICAL_TRIALS trial_result · 2023-05-08Clinical Trial Update: A Study to Evaluate the Efficacy and Safety of ZM-H1505R in Combination With ETV Compared With ETV Monotherapy in Patients With CHB [Phase 2]
Phase 2 trial evaluating ZM-H1505R plus entecavir versus entecavir alone in chronic hepatitis B patients; efficacy and safety results not ye…
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FDA approval · 2023-04-25FDA Approved: TENOFOVIR DISOPROXIL FUMARATE — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for Tenofovir disoproxil fumarate by Aurobindo Pharma Limited. This approval relates to a generic pr…
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CLINICAL_TRIALS trial_result · 2023-03-20Clinical Trial Update: The Norwegian Nucleoside Analogue Stop Study [Phase 4]
Phase 4 clinical trial update for a nucleoside analogue in chronic hepatitis B; study completed.
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CLINICAL_TRIALS trial_result · 2023-03-15Clinical Trial Update: Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Disoproxil Fumarate in Treatment Naive, HIV-1 and Hepatitis B Co-Infected Adults [Phase 3]
Phase 3 trial comparing Bictegravir/Emtricitabine/Tenofovir Alafenamide to a Dolutegravir-based regimen in treatment-naive adults co-infecte…
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CLINICAL_TRIALS trial_result · 2023-03-10Clinical Trial Update: Study to Evaluate the Immunogenicity and Safety of LBVD(Hexavalent Vaccine), Given to Healthy Infants at Primary Series [Phase 2, Phase 3]
Phase 2/3 clinical trial evaluating the immunogenicity and safety of LBVD(Hexavalent Vaccine) in healthy infants as part of the primary seri…
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EMA withdrawal · 2023-03-06EMA Withdrawn: Hepsera (adefovir dipivoxil) — Gilead Sciences Ireland UC
Hepsera (adefovir dipivoxil) has been withdrawn from the European market for chronic hepatitis B.
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CLINICAL_TRIALS trial_result · 2023-03-03Clinical Trial Update: Effect of Serum Vitamin D Level on the Efficacy of Peg-interferon Treatment in CHB [Phase 4]
A Phase 4 trial evaluating whether baseline serum vitamin D levels influence the efficacy of pegylated interferon in chronic hepatitis B.