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Clinical trials for Hepatitis B Viral Infection

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   44352   clinical trials with a EudraCT protocol, of which   7379   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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    464 result(s) found for: Hepatitis B Viral Infection. Displaying page 18 of 24.
    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: 2010-021569-58 Sponsor Protocol Number: 113948 Start Date*: 2010-11-17
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase I/II, double-blind, randomized, multicentre study to evaluate the safety and immunogenicity of new formulations of GlaxoSmithKline Biologicals’ DTPa-HBV-IPV/Hib vaccine when administered to...
    Medical condition: Primary immunization of healthy infants in the first year of life against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b (Hib) diseases.
    Disease: Version SOC Term Classification Code Term Level
    13.1 10021881 - Infections and infestations 10043376 Tetanus PT
    13.1 10021881 - Infections and infestations 10018952 Haemophilus influenzae infection LLT
    13.1 10021881 - Infections and infestations 10034738 Pertussis PT
    13.1 10021881 - Infections and infestations 10019731 Hepatitis B PT
    13.1 10021881 - Infections and infestations 10013023 Diphtheria PT
    13.1 10021881 - Infections and infestations 10036012 Poliomyelitis PT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: FI (Completed)
    Trial results: View results
    EudraCT Number: 2011-005929-49 Sponsor Protocol Number: VX11-787-101 Start Date*: 2012-02-20
    Sponsor Name:Vertex Pharmaceuticals Incorporated
    Full Title: A Phase 2a, Randomized, Double Blind, Placebo Controlled Study to Investigate the Effects of VX 787 Administered to Adult Volunteers Experimentally Inoculated with Live Influenza Virus
    Medical condition: Influenza A
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10022002 Influenza A virus infection LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2011-004724-35 Sponsor Protocol Number: VX-950HPC3006 Start Date*: Information not available in EudraCT
    Sponsor Name:Janssen-Cilag International NV
    Full Title: Open-Label, Phase 3b Study To Determine Efficacy and Safety of Telaprevir, Pegylated-Interferon-alfa-2a and Ribavirin in Hepatitis C Genotype 1 Infected, Stable Liver Transplant Subjects
    Medical condition: Chronic hepatitis C infection
    Disease: Version SOC Term Classification Code Term Level
    16.0 100000004848 10019752 Hepatitis C virus (HCV) LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) ES (Completed) GB (Completed) IT (Completed) AT (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2021-003665-35 Sponsor Protocol Number: EIG-LMD-002 Start Date*: 2022-06-10
    Sponsor Name:Eiger BioPharmaceuticals, Inc.
    Full Title: A Phase 3, Randomized, Open-Label, Parallel Arm Study to Evaluate the Efficacy and Safety of 180 mcg Peginterferon Lambda-1a (Lambda) Subcutaneous Injection for 48 Weeks in Patients with Chronic He...
    Medical condition: Chronic Hepatitis Delta Virus (HDV) Infection
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021881 - Infections and infestations 10019762 Hepatitis D PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Prematurely Ended) DE (Prematurely Ended) ES (Prematurely Ended) IT (Prematurely Ended) BG (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2014-002121-35 Sponsor Protocol Number: GS-US-337-1406 Start Date*: 2014-10-29
    Sponsor Name:Gilead Sciences, Inc.
    Full Title: A Phase 2, Open Label Study to Evaluate The Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed Dose Combination (FDC) Tablet for 12 or 24 Weeks in Kidney Transplant Recipients with Chroni...
    Medical condition: Chronic Genotype 1 and Genotype 4 Hepatitis C Virus Infection
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004848 10019751 Hepatitis C virus LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed) DE (Completed) AT (Completed)
    Trial results: View results
    EudraCT Number: 2014-000343-32 Sponsor Protocol Number: 5172-062 Start Date*: 2014-05-27
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.,
    Full Title: A Phase III Randomized Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172/MK-8742 in Treatment-Naïve Subjects with Chronic HCV GT1, GT4, and GT6 Infection who are...
    Medical condition: Hepatitis C
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004848 10019751 Hepatitis C virus LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) ES (Completed) NL (Completed) GB (Completed) RO (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2013-004586-13 Sponsor Protocol Number: 117307 Start Date*: 2014-04-28
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: Long-term hepatitis A and B antibody persistence in healthy adult subjects, primed 16 to 20 years earlier with GSK Biologicals’ combined hepatitis A and B vaccine, Twinrix® (SB208127) in study HAB-...
    Medical condition: Healthy volunteers (Vaccination against hepatitis A and hepatitis B in healthy adults)
    Disease: Version SOC Term Classification Code Term Level
    16.1 10021881 - Infections and infestations 10021881 Infections and infestations SOC
    Population Age: Adults Gender: Male, Female
    Trial protocol: BE (Completed) CZ (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2013-002802-30 Sponsor Protocol Number: GS-US-337-0124 Start Date*: 2014-03-12
    Sponsor Name:Gilead Sciences, Inc.
    Full Title: A Phase 2, Multicenter, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/Ledipasvir Fixed-Dose Combination + Ribavirin Administered in Subjects Infected with Chronic HCV who ha...
    Medical condition: Chronic Genotype 1 and Genotype 4 Hepatitis C Virus Infection
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004848 10019751 Hepatitis C virus LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) GB (Completed) DE (Completed) IT (Completed) AT (Completed) NL (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2009-015121-37 Sponsor Protocol Number: ANRS HC 23 Start Date*: 2009-12-10
    Sponsor Name:ANRS
    Full Title: Etude multicentrique randomisée ouverte comparant la réduction virale et la tolérance de l’association IFN alpha-2b XL + ribavirine versus IFN peg alpha-2b + ribavirine chez des patients atteints d...
    Medical condition: Evaluation de l’activité antivirale d’injections hebdomadaires d’un nouvel interféron α-2b à libération prolongée formulé avec Medusa® (IFNα-2bXL) chez des patients atteints d’hépatite chronique v...
    Disease: Version SOC Term Classification Code Term Level
    12.0 10008912 Chronic hepatitis C LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: View results
    EudraCT Number: 2015-004830-81 Sponsor Protocol Number: FIL_BArT Start Date*: 2015-12-24
    Sponsor Name:FONDAZIONE ITALIANA LINFOMI ONLUS
    Full Title: A multicenter study to evaluate the anti-viral activity of an interferon-free treatment with ledipasvir/sofosbuvir (G1 and G4) and sofosbuvir/velpatasvir (G2 and G3) for patients with hepatitis C v...
    Medical condition: Patients with hepatitis C virus-associated indolent B-cell lymphomas
    Disease: Version SOC Term Classification Code Term Level
    23.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10065856 Non-Hodgkin's lymphoma unspecified histology indolent PT
    20.1 10021881 - Infections and infestations 10065051 Acute hepatitis C PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2009-013652-69 Sponsor Protocol Number: AI447-016 Start Date*: 2010-01-19
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: A Phase 2a/2b study of BMS-650032 in Combination With Peginterferon Alfa-2a (Pegasys) and Ribavirin (Copegus) in Treatment-Naive Subjects with Genotypes 1 and 4 Chronic Hepatitis C Infection.
    Medical condition: Chronic Hepatitis C Virus Infection (Genotypes 1 and 4) in Treatment-Naive Subjects
    Disease: Version SOC Term Classification Code Term Level
    9.1 10008912 Chronic hepatitis C LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) GB (Completed) DE (Completed) ES (Completed) IE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2016-004102-34 Sponsor Protocol Number: M16-123 Start Date*: 2017-08-25
    Sponsor Name:AbbVie Deutschland GmbH & Co.KG
    Full Title: An Open-Label, Multicenter Study to Evaluate the Pharmacokinetics, Safety, and Efficacy of Glecaprevir/Pibrentasvir in Pediatric Subjects with Genotypes 1-6 Chronic Hepatitis C Virus (HCV) Infection
    Medical condition: Chronic Hepatitis C Infection
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004848 10019752 Hepatitis C virus (HCV) LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: ES (Completed) BE (Completed) DE (Completed) GB (GB - no longer in EU/EEA)
    Trial results: View results
    EudraCT Number: 2014-001245-24 Sponsor Protocol Number: GS-US-337-1118 Start Date*: 2014-10-01
    Sponsor Name:Gilead Sciences, Inc.
    Full Title: An open-Label, multicenter study to evaluate the efficacy and safety of sofosbuvir/ledipasvir fixed-dose combination ± ribavirin for 12 or 24 weeks in chronic genotype 1 HCV infected subjects who p...
    Medical condition: Chronic Genotype 1 Hepatitis C Virus Infection
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004848 10019751 Hepatitis C virus LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: View results
    EudraCT Number: 2006-003409-18 Sponsor Protocol Number: RRC-2/3-2006 Start Date*: 2006-11-20
    Sponsor Name:Sahlgrenska University Hospital, Östra
    Full Title: An Open-label, Multicenter Study Evaluating the Efficacy and Safety of 24 or 48 weeks pegylated interferon alfa-2a 40 kD (PEGASYS®) Combination Therapy with Ribavirin (Copegus®) in Patients with Ch...
    Medical condition: chronic hepatitis C (CHC) virus infection genotype 2 or 3 who responded during (i.e. had HCV-RNA < 50 IU/mL at the end of previous therapy), but relapsed after (i.e. had detectable HCV-RNA after th...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) DK (Completed) FI (Completed)
    Trial results: (No results available)
    EudraCT Number: 2013-003858-25 Sponsor Protocol Number: MK-5172-052 Start Date*: 2014-03-10
    Sponsor Name:Merck Sharp & Dohme Corp. a subsidiary of Merck & Co., Inc.
    Full Title: A Phase II/III Randomized Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172 and MK-8742 in Subjects with Chronic Hepatitis C Virus Infection and Chronic Kidney D...
    Medical condition: Hepatitis C
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004848 10019183 HCV LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: LT (Completed) ES (Completed) SE (Completed) EE (Completed) NL (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: 2010-020387-38 Sponsor Protocol Number: AI452-005 Start Date*: 2010-12-17
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: LIRA-B - Dose-Ranging Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Pegylated Interferon Lambda (BMS-914143) Monotherapy in Interferon-Naive Patients with Chronic Hepatitis B Virus...
    Medical condition: Chronic Hepatitis B
    Disease: Version SOC Term Classification Code Term Level
    16.0 10022891 - Investigations 10052329 Hepatitis B e antigen positive PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) IT (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2008-003538-11 Sponsor Protocol Number: 1220.5 Start Date*: 2008-10-01
    Sponsor Name:Boehringer Ingelheim Pharma GmbH & Co. KG
    Full Title: Antiviral effect, safety and pharmacokinetics of BI 201335 NA in hepatitis C virus genotype 1 infected treatment-naïve and treatment-experienced patients for 24 weeks as combination therapy with pe...
    Medical condition: chronic hepatitis C infection of genotype 1
    Disease: Version SOC Term Classification Code Term Level
    14.0 10021881 - Infections and infestations 10047457 Viral hepatitis C LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) ES (Completed) FR (Completed) NL (Completed) PT (Completed) GB (Completed) AT (Completed) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2015-001956-31 Sponsor Protocol Number: 2015-001956-31 Start Date*: 2015-06-09
    Sponsor Name:Department of Infectious Diseases, Copenhagen University Hospital, Hvidovre.
    Full Title: Direct acting antiviral therapy of hepatitis C in Denmark: treatment response, adverse events and resistance associated variants
    Medical condition: Patients with chronic hepatitis C
    Disease: Version SOC Term Classification Code Term Level
    19.1 100000004862 10074391 Chronic hepatitis C virus genotype 1 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (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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