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Clinical trials for HBsAg

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44339   clinical trials with a EudraCT protocol, of which   7369   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    442 result(s) found for: HBsAg. Displaying page 1 of 23.
    1  2  3  4  5  6  7  8  9  Next» Last»»
    EudraCT Number: 2012-000080-25 Sponsor Protocol Number: ML28262 Start Date*: 2012-09-18
    Sponsor Name:ROCHE
    Full Title: A Phase IIb, Open Label, Single Arm, Multicenter Study to Evaluate the Effect of 48-weeks Peginterferon alfa-2a (PEG-IFN) Administration on Serum HBsAg in Chronic Hepatitis B, HBeAg-Negative, Genot...
    Medical condition: Chronic Hepatitis B
    Disease: Version SOC Term Classification Code Term Level
    15.0 10021881 - Infections and infestations 10008910 Chronic hepatitis B LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2011-002629-23 Sponsor Protocol Number: 100449 Start Date*: 2015-05-22
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: Immunogenicity and protective efficacy of GlaxoSmithKline Biologicals’ rec-Hepatitis B vaccine (10 µg) in newborns of Hepa-titis B envelope antigen positive (HBeAg+) and Hepatitis B surface antigen...
    Medical condition: Hepatitis B vaccination in healthy newborns of HBeAg+ and HBsAg+ mothers
    Disease:
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2011-002010-37 Sponsor Protocol Number: HBV1101 Start Date*: 2012-02-17
    Sponsor Name:Foundation for Liver research
    Full Title: A Multi-center, Randomized, Open-label study for Induction of HBsAg decline using an add-on treatment of peginterferon alfa-2a in HBeAg-negative chronic hepatitis B patients treated with nucleos(t)...
    Medical condition: Chronic hepatitis B virus infection
    Disease: Version SOC Term Classification Code Term Level
    18.0 10021881 - Infections and infestations 10008910 Chronic hepatitis B PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2013-004882-15 Sponsor Protocol Number: STOP-NUC Start Date*: 2014-10-30
    Sponsor Name:Universität Leipzig
    Full Title: A multicentre randomized controlled trial evaluating the rate of sustained remission and the safety when stopping nucleos(t)ide analogue treatment in non-cirrhotic HBeAg-negative chronic Hepatitis ...
    Medical condition: HBeAg negative chronic Hepatitis B virus (HBV) infection
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021881 - Infections and infestations 10008910 Chronic hepatitis B PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2008-004455-29 Sponsor Protocol Number: 112115 Start Date*: 2008-12-05
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase II, randomized, multicentre, observer-blind study to compare and characterize the immunoginicity and safety parameters induced by various GSK Biologicals’ Adjuvant Systems in combination wi...
    Medical condition: Hepatitis B surface antigen (HBsAg) vaccine administred in HBV naïve adult subjects aged between 18 and 45 years old, inclusive, in good general health.
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: BE (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2011-004879-36 Sponsor Protocol Number: 100450 Start Date*: 2015-05-22
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: Comparative study of the immunogenicity and protective efficacy of GlaxoSmithKline Biologicals’ rec-DNA Hepatitis B vaccine (10µg) with or without Hepatitis B immunoglobulin (HBIG) in newborns of H...
    Medical condition: Vaccination of healthy newborns of HBsAg+ and/or HBeAg+ mothers against Hepatitis.
    Disease:
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2016-001010-17 Sponsor Protocol Number: 16SM3217 Start Date*: 2016-08-26
    Sponsor Name:Imperial College, London
    Full Title: Nucleos(t)ide withdrawal in HBeAg negative hepatitis B virus infection to promote HBsAg clearance. (NUC-B)
    Medical condition: Hepatitis B viral infection
    Disease: Version SOC Term Classification Code Term Level
    19.0 10021881 - Infections and infestations 10008910 Chronic hepatitis B PT
    19.0 10022891 - Investigations 10052297 Hepatitis B e antigen negative PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2019-001629-28 Sponsor Protocol Number: EYP001-201 Start Date*: 2019-11-06
    Sponsor Name:ENYO Pharma SA
    Full Title: A Phase 2a, randomized, double-blind, placebo-controlled study of oral FXR modulator EYP001a combined with nucleos(t)ide analogues (NA) in virologically suppressed chronic hepatitis B patients to i...
    Medical condition: Chronic Hepatitis B
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021881 - Infections and infestations 10008910 Chronic hepatitis B PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: PL (Ongoing)
    Trial results: View results
    EudraCT Number: 2015-005499-46 Sponsor Protocol Number: Heparc-2008 Start Date*: 2016-06-24
    Sponsor Name:Arrowhead Pharmaceuticals, Inc.
    Full Title: A Multicenter, Open-Label Study to Evaluate ARC-520 Administered Alone and in Combination with Other Therapeutics in Patients with Chronic Hepatitis B Virus (HBV) Infection (MONARCH)
    Medical condition: Chronic Hepatitis B Virus (HBV) Infection
    Disease: Version SOC Term Classification Code Term Level
    19.0 10021881 - Infections and infestations 10008910 Chronic hepatitis B PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BG (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2014-001011-39 Sponsor Protocol Number: GS-US-330-1401 Start Date*: 2015-03-26
    Sponsor Name:Gilead Sciences, Inc.
    Full Title: A Phase 2, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of GS-4774 in combination with Tenofovir Disoproxil Fumarate (TDF) for the Treatment of Subjects with Chronic Hepatitis B...
    Medical condition: Chronic Hepatitis B
    Disease: Version SOC Term Classification Code Term Level
    17.1 10021881 - Infections and infestations 10008910 Chronic hepatitis B PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2022-002014-16 Sponsor Protocol Number: VIR-MHB1-V200 Start Date*: 2023-05-17
    Sponsor Name:Vir Biotechnology, Inc.
    Full Title: A Platform Study Evaluating the Efficacy and Safety of Investigational Therapies in Participants with Chronic Hepatitis B Infection (PREVAIL)
    Medical condition: Chronic Hepatitis B Virus (HBV) Infection
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021881 - Infections and infestations 10008910 Chronic hepatitis B PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) BG (Prematurely Ended) RO (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-002000-39 Sponsor Protocol Number: 212602 Start Date*: 2020-09-29
    Sponsor Name:GlaxoSmithKline Research & Development Limited
    Full Title: B-Fine: An open label, single arm study to mechanistically interrogate the therapeutic effect of GSK3228836 in patients with Chronic Hepatitis B via intrahepatic immunophenotyping
    Medical condition: Chronic Hepatitis B
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021881 - Infections and infestations 10008910 Chronic hepatitis B PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) GB (GB - no longer in EU/EEA)
    Trial results: View results
    EudraCT Number: 2021-005362-18 Sponsor Protocol Number: HBIGforcure Start Date*: 2022-04-13
    Sponsor Name:Hannover Medical School
    Full Title: Hepatitis B immunoglobulins to induce HBsAg clearance in patients with chronic hepatitis B
    Medical condition: HBeAg negative patients with chronic HBV infection will be allocated into two different cohorts, cohort A and cohort B.
    Disease: Version SOC Term Classification Code Term Level
    21.0 10022891 - Investigations 10052297 Hepatitis B e antigen negative PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2019-000622-22 Sponsor Protocol Number: 73763989HPB2001 Start Date*: 2019-08-20
    Sponsor Name:Janssen Sciences Ireland UC
    Full Title: A Phase 2b, Multicenter, Double-blind, Active-controlled, Randomized Study to Investigate the Efficacy and Safety of Different Combination Regimens Including JNJ-73763989 and/or JNJ-56136379 for th...
    Medical condition: Chronic Hepatitis B Virus Infection
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021881 - Infections and infestations 10008910 Chronic hepatitis B PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) FR (Completed) DE (Completed) CZ (Completed) ES (Completed) BE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2012-002777-56 Sponsor Protocol Number: ML28470 Start Date*: 2012-08-20
    Sponsor Name:ROCHE
    Full Title: Cross-sectional multicenter study evaluating the IL28B polymorphism in patients with HBeAg-negative chronic hepatitis B treated with pegylated interferon alfa-2a in the course of Peg.Be.Liver study
    Medical condition: HBeAg-negative chronic hepatitis B
    Disease: Version SOC Term Classification Code Term Level
    15.0 10021881 - Infections and infestations 10008910 Chronic hepatitis B LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2015-001050-16 Sponsor Protocol Number: GS-US-330-1508 Start Date*: 2016-06-23
    Sponsor Name:GILEAD SCIENCES INCORPORATED
    Full Title: A Long Term Follow-up Registry of Subjects Treated in A Gilead-Sponsored Trial in Subjects with Chronic Hepatitis B Infection.
    Medical condition: Chronic Hepatitis B virus infection
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10019731 Hepatitis B PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2009-015877-11 Sponsor Protocol Number: DV2-HBV-17 Start Date*: 2010-07-09
    Sponsor Name:Dynavax Technologies Corporation
    Full Title: An Observer-Blinded, Randomized Study Comparing the Safety and Immunogenicity of HEPLISAV™ to Licensed Vaccine (Engerix-B®) among Adults (18 to 75 Years of Age) with Chronic Kidney Disease (CKD)
    Medical condition: Prevention of hepatitis B virus (HBV) infection
    Disease: Version SOC Term Classification Code Term Level
    14.0 10042613 - Surgical and medical procedures 10054181 Hepatitis B immunization LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2019-001139-30 Sponsor Protocol Number: YP39364 Start Date*: 2019-07-10
    Sponsor Name:F. Hoffman-La Roche Ltd.
    Full Title: A SAFETY, TOLERABILITY, PHARMACOKINETICS AND EFFICACY STUDY OF RO7049389 IN: (1) SINGLE- (WITH OR WITHOUT FOOD) AND MULTIPLE- (WITH MIDAZOLAM) ASCENDING DOSES IN HEALTHY VOLUNTEERS; (2) PATIENTS C...
    Medical condition: Chronic Hepatitis B
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021881 - Infections and infestations 10008910 Chronic hepatitis B PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: BG (Completed)
    Trial results: View results
    EudraCT Number: 2019-002674-31 Sponsor Protocol Number: 73763989PAHPB2002 Start Date*: 2019-12-16
    Sponsor Name:Janssen Sciences Ireland UC
    Full Title: A Randomized, Double blind, Placebo-controlled Phase 2b Study to Evaluate Efficacy, Pharmacokinetics, and Safety of 48-week Study Intervention With JNJ-73763989+JNJ-56136379+Nucleos(t)ide Analog (N...
    Medical condition: Chronic Hepatitis B Virus Infection
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021881 - Infections and infestations 10008910 Chronic hepatitis B PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: BE (Completed) DE (Completed) FR (Completed) PL (Completed) ES (Ongoing) IT (Completed)
    Trial results: View results
    EudraCT Number: 2017-001110-29 Sponsor Protocol Number: 56136379HPB2001 Start Date*: 2018-02-20
    Sponsor Name:Janssen Sciences Ireland UC
    Full Title: A Phase 2a, Randomized, Partially-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Pharmacokinetics of Treatment With Multiple Doses of JNJ-56136379 as Monotherapy and in Combina...
    Medical condition: Chronic Hepatitis B Virus Infection
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021881 - Infections and infestations 10008910 Chronic hepatitis B PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) BE (Completed) DE (Completed) ES (Completed) PL (Completed) IT (Completed)
    Trial results: View results
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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