Hepatitis B
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CLINICAL_TRIALS withdrawal · 2015-06-16Clinical Trial Update: Randomized Controlled Study of Tenofovir Plus Telbivudine Versus Monotherapy With Either Drug in HBeAg Negative Chronic Hepatitis B Patients [NA]
A randomized trial comparing Tenofovir disoproxil fumarate plus telbivudine versus monotherapy with either drug in HBeAg-negative chronic he…
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CLINICAL_TRIALS withdrawal · 2015-03-09Clinical Trial Update: Trial of Telbivudine Combination Therapy vs. Continued Adefovir Monotherapy [Phase 4]
This Phase 4 trial comparing telbivudine in combination with adefovir versus continued adefovir monotherapy for chronic hepatitis B has been…
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CLINICAL_TRIALS withdrawal · 2015-01-28Clinical Trial Update: The Regression of Liver Fibrosis and Risk for Hepatocellular Carcinoma (ROLFH) Study
The ROLFH study investigating regression of liver fibrosis and risk for hepatocellular carcinoma in chronic hepatitis C and chronic hepatiti…
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CLINICAL_TRIALS withdrawal · 2014-12-18Clinical Trial Update: A Study With Clevudine Monotherapy or Adefovir and Clevudine Combination in Patients With Chronic Hepatitis B [Phase 4]
A Phase 4 trial evaluating clevudine as monotherapy or in combination with adefovir for chronic hepatitis B has been terminated.
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CLINICAL_TRIALS withdrawal · 2014-12-18Clinical Trial Update: A Study to Compare and Evaluate Intrahepatic cccDNA Reduction After Administrating Clevudine or Entecavir in the Chronic HBV Patients [Phase 4]
A Phase 4 clinical trial comparing clevudine versus entecavir in patients with chronic hepatitis B was terminated.
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CLINICAL_TRIALS withdrawal · 2014-06-18Clinical Trial Update: Prevalence of Hepatitis B Infection in the Galilee Region, Israel
A clinical trial evaluating the prevalence of Hepatitis B infection in the Galilee region of Israel (NCT01645007) has been withdrawn.
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EMA withdrawal · 2014-05-26EMA Application withdrawn: Heplisav — Dynavax International B.V.
The EMA withdrew the application for Heplisav by Dynavax International B.V. for hepatitis B indication.
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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 withdrawal · 2013-09-19Clinical Trial Update: A Study to Compare Efficacy and Safety of Tenofovir Used Alone or in Combination With Pegylated Interferon Alpha-2b in Participants With Chronic Hepatitis B and Elevated Alanine Aminotransferase (MK-4031-384) [Phase 4]
A Phase 4 trial comparing tenofovir alone versus in combination with pegylated interferon alfa-2b for chronic hepatitis B has been withdrawn…
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EMA withdrawal · 2013-08-23EMA Lapsed: Infanrix Penta (Diphtheria toxoid;tetanus toxoid;Bordetella pertussis antigens (pertussis toxoid, filamentous haemagglutinin, pertactin);poliovirus (inactivated) (type 1 (Mahoney strain), type 2 (MEF-1 strain), type 3 (Saukett strain));hepatitis B surface antigen) — GlaxoSmithKline Biologicals S.A.
EMA status indicates Infanrix Penta is lapsed, with the product no longer active in this market.
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CLINICAL_TRIALS withdrawal · 2012-08-28Clinical Trial Update: Follow Up of Patients Chronic Hepatitis B (CHB) Treated With Sebivo Using the 13C Methacetin Breath Test [Phase 2, Phase 3]
A Phase 2/3 clinical trial evaluating Sebivo (telbivudine) for chronic hepatitis B has been withdrawn.
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EMA withdrawal · 2012-08-16EMA Withdrawn: Hexavac (purified diphtheria toxoid;purified tetanus toxoid;purified pertussis toxoid;purified pertussis filamentous haemagglutinin;hepatitis B surface antigen;Inactivated Type 1 Poliovirus (Mahoney);Inactivated Type 3 Poliovirus (Saukett);Haemophilus influenzae type b polysaccharide) — Sanofi Pasteur MSD, SNC
The EMA has withdrawn Hexavac, a hexavalent combination vaccine, from the market. The decision was taken in 2012 and concerns multiple indic…
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CLINICAL_TRIALS withdrawal · 2012-05-02Clinical Trial Update: Efficacy and Safety of Telbivudine in Patients With Chronic Hepatitis B [Phase 4]
A Phase 4 trial of telbivudine for chronic hepatitis B has been withdrawn; the document provides no efficacy or safety data.
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CLINICAL_TRIALS withdrawal · 2012-04-20Clinical Trial Update: Efficacy Study of Prednisone Priming to Treat Asian Chronic Hepatitis B Patients [NA]
A clinical trial evaluating prednisone priming as a treatment for chronic hepatitis B in Asian patients has been withdrawn (NCT00715715).
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CLINICAL_TRIALS withdrawal · 2012-01-19Clinical Trial Update: Maraviroc Versus Etravirine In Combination With Antiretroviral Therapy In Drug Experienced HIV And Hepatitis Co-Infected Patients [Phase 4]
A Phase 4 trial comparing maraviroc versus etravirine in combination antiretroviral therapy for drug-experienced HIV patients co-infected wi…
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EMA withdrawal · 2011-01-26EMA Withdrawn: ImmunoGam (human hepatitis B immunoglobulin) — Cangene Europe Limited
EMA withdrew ImmunoGam, a human hepatitis B immunoglobulin product, from the market in 2010.
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EMA withdrawal · 2009-07-29EMA Expired: Procomvax (polyribosylribitol phosphate from Haemophilus influenzae type b as PRP-OMPC;outer membrane protein complex of Neisseria meningitidis (outer membrane protein complex of the B11 strain of Neisseria meningitidis subgroup B);adsorbed hepatitis B surface antigen produced in recombinant yeast cells (Saccharomyces cerevisiae)) — Sanofi Pasteur MSD, SNC
The EMA indicates that Procomvax, a combination vaccine for hepatitis B and meningitis Haemophilus influenzae type b, has expired (product s…
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CLINICAL_TRIALS withdrawal · 2009-04-20Clinical Trial Update: Comparison of Telbivudine Versus Lamivudine on the Early Dynamics and Kinetics of Viral Suppression in Chronic Hepatitis B [Phase 4]
A Phase 4 clinical trial comparing telbivudine to lamivudine for chronic hepatitis B was withdrawn from the study status.
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EMA withdrawal · 2008-11-19EMA Withdrawn: Viraferon (interferon alfa-2b) — Schering-Plough Europe
EMA withdrawal of Viraferon (interferon alfa-2b) by Schering-Plough Europe for chronic hepatitis B and C.
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EMA withdrawal · 2008-09-10EMA Withdrawn: Quintanrix (Diphtheria toxoid;tetanus toxoid;inactivated Bordetella pertussis;hepatitis B surface antigen (rDNA);Haemophilus influenzae type b polysaccharide) — GlaxoSmithKline Biologicals S.A.
Quintanrix has been withdrawn from the market by GlaxoSmithKline Biologicals S.A., with the status indicating withdrawal for its diphtheria,…