Hepatitis B
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Sign up freeTop drugs studied for this disease
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FDA approval · 2014-03-20FDA Approved: BARACLUDE — Supplemental Application (E.R. Squibb & Sons, L.L.C.)
The FDA approved a supplemental application for Baraclude (entecavir) submitted by E.R. Squibb & Sons, L.L.C., resulting in an approved modi…
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CLINICAL_TRIALS trial_result · 2014-03-10Clinical Trial Update: Study to Evaluate the Safety and Immunogenicity of Combined Hepatitis A/B Vaccine With MenACWY-CRM Conjugate Vaccine [Phase 3]
A Phase 3 study evaluating the safety and immune response of a combined Hepatitis A/B vaccine with the MenACWY-CRM meningococcal conjugate v…
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CLINICAL_TRIALS research · 2014-03-10Clinical Trial Update: Innate Immunity in HIV Positive Patients Co-infected With Hepatitis C Virus (HCV) or Hepatitis B Virus (HBV)
Clinical trial update examining innate immunity in HIV-positive patients co-infected with hepatitis B or hepatitis C. The trial status is cu…
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CLINICAL_TRIALS trial_result · 2014-03-07Clinical Trial Update: A Single-arm Study Evaluating the Efficacy and Safety of Telbivudine With or Without add-on Tenofovir in Adults With HBeAg-positive Chronic Hepatitis B (CHB) [Phase 4]
A Phase 4, single-arm study assessing telbivudine with or without add-on tenofovir in adults with HBeAg-positive chronic hepatitis B has com…
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CLINICAL_TRIALS trial_result · 2014-03-04Clinical Trial Update: Immunogenicity and Safety of the Hepatitis B Vaccine Hepavax-Gene TF and a Comparator Hepatitis B Vaccine in Newborns [Phase 3]
Phase 3 trial update reporting immunogenicity and safety data for the Hepavax-Gene TF hepatitis B vaccine in newborns, compared with a compa…
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CLINICAL_TRIALS trial_result · 2014-03-04Clinical Trial Update: Rollover Protocol Continued Access to Tenofovir Disoproxil Fumarate (TDF) for Subjects in Taiwan [Phase 2]
This update confirms that the rollover/continued-access protocol for Tenofovir Disoproxil Fumarate in hepatitis B patients in Taiwan has com…
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CLINICAL_TRIALS trial_result · 2014-02-24Clinical Trial Update: Serum Hepatitis B Surface Antigen Levels to Guide the Stopping of Entecavir in HBeAg-negative Chronic Hepatitis B
A completed clinical trial evaluating whether Hepatitis B surface antigen levels can guide stopping entecavir in patients with HBeAg-negativ…
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CLINICAL_TRIALS trial_result · 2014-02-17Clinical Trial Update: Modified Process Hepatitis B Vaccine in Japanese Young Adults (V232-062) [Phase 3]
A Phase 3 clinical trial update reports results for a modified process Hepatitis B vaccine in Japanese young adults; results were posted in …
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CLINICAL_TRIALS trial_result · 2014-02-17Clinical Trial Update: Adefovir and Lamivudine for Entecavir Resistance (ALTER Study) [Phase 4]
Phase 4 ALTER study evaluating the use of adefovir and lamivudine for patients with entecavir-resistant chronic hepatitis B has completed.
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CLINICAL_TRIALS trial_result · 2014-02-13Clinical Trial Update: Efficacy and Safety Study of Entecavir Plus Tenofovir in Patients With Chronic Hepatitis B Who Failed Previous Treatment [Phase 3]
Phase 3 trial evaluating the efficacy and safety of combining entecavir with tenofovir in patients with chronic hepatitis B who failed prior…
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CLINICAL_TRIALS safety_alert · 2014-02-06Clinical Trial Update: Hepatitis B Virus Reactivation After Withdrawal of Preemptive Antiviral Therapy in Hematologic Malignancy
The update reports hepatitis B virus reactivation after withdrawal of preemptive antiviral therapy in patients with hematologic malignancies…
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CLINICAL_TRIALS trial_result · 2014-02-04Clinical Trial Update: Immunogenicity of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® at 2-3-4 Months Schedule [Phase 3]
Phase 3 trial assessing the immunogenicity of a combined DTaP-IPV-Hep B-PRP~T vaccine versus PENTAXIM and ENGERIX B in infants at 2- to 4-mo…
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CLINICAL_TRIALS trial_result · 2014-01-31Clinical Trial Update: Antiviral Efficacy of Switching to ETV Plus TDF [Phase 4]
Phase 4 clinical trial evaluating antiviral efficacy when switching chronic hepatitis B patients to a combination of entecavir and tenofovir…
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CLINICAL_TRIALS research · 2014-01-31Clinical Trial Update: Entecavir Plus Tenofovir Combination in Subjects With Multi-drug Resistant Chronic Hepatitis B Virus Infection [Phase 4]
Phase 4 trial evaluating the combination of entecavir and tenofovir for multi-drug resistant chronic hepatitis B; trial status is unknown.
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CLINICAL_TRIALS trial_result · 2014-01-24Clinical Trial Update: Hepatitis B Antigen Kidney Graft Into Protective Level Hepatitis B Antibody Recipients
The update describes a clinical trial evaluating kidney transplants from hepatitis B surface antigen-positive donors into recipients with pr…
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CLINICAL_TRIALS trial_result · 2014-01-14Clinical Trial Update: Study of PR5I, a Pediatric Combination Vaccine With Enhanced Hepatitis B Component Given Concomitantly With Prevnar® [Phase 2]
Phase 2 study evaluating PR5I, a pediatric combination vaccine with an enhanced Hepatitis B component, given concomitantly with Prevnar; the…
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CLINICAL_TRIALS safety_alert · 2014-01-13Clinical Trial Update: Post-marketing Safety Study of GSK Biological's Pediarix™ Vaccine
This is a completed post-marketing safety study of GlaxoSmithKline's Pediarix vaccine, a DTaP-HepB-IPV combination, evaluating safety for He…
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CLINICAL_TRIALS trial_result · 2014-01-13Clinical Trial Update: Entecavir Plus Adefovir in Lamivudine-Resistant Chronic Hepatitis B Patients Who Fail Lamivudine Plus Adefovir [Phase 4]
This Phase 4 trial assesses the combination of entecavir and adefovir in lamivudine-resistant chronic hepatitis B patients who fail lamivudi…
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CLINICAL_TRIALS research · 2014-01-13Clinical Trial Update: Antigen-specific Immune Response to Hepatitis B Virus in Utero
An update on a clinical trial studying antigen-specific immune responses to Hepatitis B virus in utero; current status is not provided.
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CLINICAL_TRIALS trial_result · 2014-01-08Clinical Trial Update: Incidence of Hepatitis B Virus (HBV) Reactivation in HBsAg Negative/HBcAb Positive Lymphoma Patients Treated With RCHOP [Phase 2, Phase 3]
This clinical trial update discusses the incidence of hepatitis B reactivation in lymphoma patients who are HBsAg negative and HBcAb positiv…
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CLINICAL_TRIALS approval · 2014-01-07Clinical Trial Update: An Open-Label Program of Adefovir Dipivoxil in the Treatment of Patients With Lamivudine-Resistant Chronic Hepatitis B With Limited Treatment Options
Regulatory approval for marketing of adefovir dipivoxil for lamivudine-resistant chronic hepatitis B, expanding treatment options for patien…
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EMA withdrawal · 2014-01-07EMA Lapsed: Tritanrix HepB (Diphtheria toxoid;hepatitis B surface antigen;Bordetella pertussis (inactivated);tetanus toxoid) — GlaxoSmithKline Biologicals S.A.
EMA status shows the Tritanrix HepB vaccine has lapsed and is no longer an active medicinal product in the EU.
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CLINICAL_TRIALS trial_result · 2014-01-07Clinical Trial Update: Observational Study of the Durability of Seroconversion Chronic HBV Patients Who Seroconverted in a Previous Gilead-Sponsored Study of ADV.
This clinical trial update reports on the durability of seroconversion in chronic hepatitis B patients who previously seroconverted in a Gil…
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CLINICAL_TRIALS trial_result · 2014-01-03Clinical Trial Update: Safety and Pharmacokinetics Study of Healthy Male Adults When Repeatedly Administered Through Intravenous Injection [Phase 1]
This is a Phase 1 safety and pharmacokinetics study in healthy male adults receiving repeated intravenous injections, sponsored by Green Cro…
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FDA approval · 2014-01-02FDA Approved: LAMIVUDINE — Original Application (Camber Pharmaceuticals, Inc.)
FDA approved Camber Pharmaceuticals' generic lamivudine tablet under an Original Application (ANDA). Lamivudine is used to treat HIV-1 infec…