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Clinical trials for HBeAg

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   44347   clinical trials with a EudraCT protocol, of which   7375   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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    117 result(s) found for: HBeAg. Displaying page 1 of 6.
    1  2  3  4  5  6  Next»
    EudraCT Number: 2007-001789-34 Sponsor Protocol Number: OptiB2007 Start Date*: 2007-10-05
    Sponsor Name:AZIENDA UNIVERSITARIA POLICLINICO UMBERTO I DI ROMA
    Full Title: A multicenter open label study to explore the efficacy and tolerability of Tenofovir DF (TDF) (300 mg) in chronic hepatitis B, HBeAg positive or negative, patients with suboptimal response to adefo...
    Medical condition: Chronic Hepatitis B HBV
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10019731 Hepatitis B PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2011-002732-70 Sponsor Protocol Number: YV25718 Start Date*: 2012-02-09
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: A Phase IIIb Parallel Group, Open Label Study of Pegylated Interferon alfa-2a Monotherapy (PEG-IFN, Ro 25-8310) Compared to Untreated Control in Children with HBeAg Positive Chronic Hepatitis B in ...
    Medical condition: Treatment of HBeAg positive chronic hepatitis B (CHB) in children.
    Disease: Version SOC Term Classification Code Term Level
    16.0 100000004848 10052552 Hepatitis B virus LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) BE (Completed) DE (Completed) PL (Completed) IT (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2006-000977-31 Sponsor Protocol Number: NV25361 Start Date*: 2006-05-05
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: PHASE IIIB, RANDOMIZED, OPEN LABEL STUDY OF PEGYLATED INTERFERON ALFA-2A IN COMBINATION WITH LAMIVUDINE OR ENTECAVIR COMPARED WITH UNTREATED CONTROL PATIENTS IN CHILDREN WITH HBEAG POSITIVE CHRONIC...
    Medical condition: Chronic Hepatitis B Virus infection
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004848 10019743 Hepatitis B virus (HBV) LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) BE (Completed) IT (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: 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: 2008-006239-11 Sponsor Protocol Number: HBV 09-01 Start Date*: 2009-05-15
    Sponsor Name:Stichting Lever Onderzoek
    Full Title: Augmenting response to entecavir using a temporary peginterferon alpha-2a add-on strategy for the treatment of HBeAg-positive chronic hepatitis B (ARES study)
    Medical condition: Chronic hepatitis B virus infection
    Disease: Version SOC Term Classification Code Term Level
    9.1 10008910 Chronic hepatitis B LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2007-000180-13 Sponsor Protocol Number: CLDT600A2409 Start Date*: 2011-02-03
    Sponsor Name:Novartis Pharma Services AG
    Full Title: OPTIMA: A Randomized, Open-label, 104-week Treatment Study to Evaluate the Efficacy and Safety of Telbivudine or Tenofovir Treatment in HBeAg-negative Chronic Hepatitis B Patients Based on the Road...
    Medical condition: Treatment in HBeAg-negative chronic hepatitis B patients
    Disease: Version SOC Term Classification Code Term Level
    16.0 10021881 - Infections and infestations 10008910 Chronic hepatitis B PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: AT (Completed) ES (Completed) DE (Completed) GR (Completed) BG (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2005-005849-19 Sponsor Protocol Number: RHM MED 0673 Start Date*: 2006-07-06
    Sponsor Name:Southampton University Hospitals NHS Trust
    Full Title: Finite duration treatment in pre-cirrhotic chronic hepatitis B virus (HBV) infection: Phase IV study of Lamivudine priming of Pegasys treatment in HBeAg positive patients
    Medical condition: pre-cirrhotic chronic hepatitis B virus (HBV) infection
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2015-004890-34 Sponsor Protocol Number: ADF105220 Start Date*: 2016-12-21
    Sponsor Name:GlaxoSmithKline K.K.
    Full Title: Phase III study of adefovir dipivoxil tablets in patients with compensated chronic hepatitis B (comparative study against lamivudine).
    Medical condition: Hepatitis B, Chronic
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2006-005370-49 Sponsor Protocol Number: ML20601 Start Date*: 2006-12-13
    Sponsor Name:Roche Latvia
    Full Title: Baltic Post-marketing Program of PEGASYS® (Peg interferon alpha-2a 40KD) in Patients with HBeAg-positive Chronic Hepatitis B
    Medical condition: HBeAg positive chronic Hepatitis B virus (ICD classification code: B18)
    Disease: Version SOC Term Classification Code Term Level
    8.1 10008910 Chronic hepatitis B LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: EE (Completed) LT (Completed) LV (Completed)
    Trial results: View results
    EudraCT Number: 2004-004736-30 Sponsor Protocol Number: HBV05-01 Start Date*: 2005-01-20
    Sponsor Name:Erasmus MC
    Full Title: Peginterferon alfa-2a and Ribavirin Combination Therapy in Patients with HBeAg-negative Chronic HBV Infection
    Medical condition: chronic HBV infection
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: AT (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2006-000421-62 Sponsor Protocol Number: AI463-110 Start Date*: 2007-06-06
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: A Comparative Study of Chronic Hepatitis B Subjects Treated with Entecavir Plus Tenofovir Combination Therapy vs Entecavir Monotherapy in Adults who are Treatment-Naïve to Nucleosides and Nucleotid...
    Medical condition: CHRONIC HEPATITIS B VIRUS,TREATMENT-NAIV
    Disease: Version SOC Term Classification Code Term Level
    8.1 10019743 Hepatitis B virus (HBV) LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) IT (Completed) GR (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: 2006-004003-18 Sponsor Protocol Number: CLDT600A2406 Start Date*: 2006-11-16
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A randomized, open-label, controlled, mutli-center two-year study comparing efficacy and safety of telbivudine 600mg PO in combination with peg alpha-2a 180 µg with peg alpha-2a montherapy, and wit...
    Medical condition: Treatment of naïve patients with HBeAg-positive compensated chronic hepatitis B
    Disease: Version SOC Term Classification Code Term Level
    8.1 10008910 Chronic hepatitis B LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Prematurely Ended) FR (Prematurely Ended) IT (Completed) DE (Prematurely Ended) BE (Completed) NL (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2018-000724-34 Sponsor Protocol Number: Nuc-STOP Start Date*: 2018-07-02
    Sponsor Name:Oslo University Hospital HF
    Full Title: Norwegian Nucleoside Analogue Stop Study (Nuc-STOP) - A randomized open-label trial in HBeAg negative chronic hepatitis B, aiming at achieving a functional Cure
    Medical condition: HBeAg negative chronic hepatitis B
    Disease: Version SOC Term Classification Code Term Level
    20.1 10022891 - Investigations 10052297 Hepatitis B e antigen negative PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NO (Completed) SE (Completed) DK (Completed)
    Trial results: View results
    EudraCT Number: 2006-000870-63 Sponsor Protocol Number: WV19432 Start Date*: 2007-03-01
    Sponsor Name:F.Hoffmann-La Roche Ltd
    Full Title: A phase IV, 2x2 factorial, double blind study of 24 versus 48 weeks and 90 versus 180 mcg doses of pegylated interferon alfa 2a 40KD (PEG IFN, Ro 25-8310) in adult patients with HBeAg positive chro...
    Medical condition: Chronic hepatitis B
    Disease: Version SOC Term Classification Code Term Level
    9.1 10008910 Chronic hepatitis B LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2015-005136-18 Sponsor Protocol Number: ARB-001467-002 Start Date*: 2016-04-13
    Sponsor Name:Arbutus Biopharma Corporation
    Full Title: A Phase 2a, Single-Blind, Randomized, Placebo-Controlled Study Evaluating the Safety, Anti-Viral Activity, and Pharmacokinetics of ARB-001467 in Non-Cirrhotic, HBeAg-Negative and Positive Subjects ...
    Medical condition: Hepatitis B virus e-antigen (HBeAg)-negative and HBeAg-positive subjects with chronic Hepatitis B virus (HBV)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004848 10054283 HBV DNA detectable LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: (No results available)
    EudraCT Number: 2008-007446-54 Sponsor Protocol Number: HBV99-03 Start Date*: 2009-03-26
    Sponsor Name:Department of Gastroenterology and Hepatology, Erasmus MC, Rotterdam
    Full Title: LOWERING VIRAL LOAD WITH NUCLEOS(T)IDE ANALOGUES PRIOR TO PEG-INTERFERON ALFA-2B TREATMENT TO INCREASE SUSTAINED RESPONSE IN HBEAG-POSITIVE CHRONIC HEPATITIS B (PADD-STUDY)
    Medical condition: Chronic hepatitis B virus infection
    Disease: Version SOC Term Classification Code Term Level
    9.1 10008910 Chronic hepatitis B LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    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: 2018-004019-34 Sponsor Protocol Number: ABI-H0731-211 Start Date*: 2019-02-20
    Sponsor Name:Assembly Biosciences
    Full Title: A Multi-center, Open-label, Long-term Extension Study of ABI-H0731 + Nucleos(t)ide as Finite Treatment for Chronic Hepatitis B Patients
    Medical condition: Chronic Hepatitis B
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    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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