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Clinical trials for Virus Diseases AND HBV AND Placebo

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   44398   clinical trials with a EudraCT protocol, of which   7410   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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    49 result(s) found for: Virus Diseases AND HBV AND Placebo. Displaying page 1 of 3.
    1  2  3  Next»
    EudraCT Number: 2015-004360-10 Sponsor Protocol Number: ALN-HBV-001 Start Date*: 2016-04-06
    Sponsor Name:Alnylam Pharmaceuticals, Inc
    Full Title: A Phase 1/2, Randomized, Single-Blind, Placebo-Controlled, Single-Ascending and Multiple-Ascending Dose, Safety, Tolerability, Pharmacokinetics, and Antiviral Efficacy Study of Subcutaneously Admin...
    Medical condition: Chronic Hepatitis B virus (HBV) Infection
    Disease: Version SOC Term Classification Code Term Level
    18.1 10021881 - Infections and infestations 10008910 Chronic hepatitis B PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (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: 2019-004902-85 Sponsor Protocol Number: ABI-H2158-201 Start Date*: 2020-10-30
    Sponsor Name:Assembly Biosciences
    Full Title: A Phase 2a, Multicenter, Single-Blind, Placebo-Controlled, Multiple Cohort Study Evaluating ABI-H2158-Containing Regimens in Chronic Hepatitis B Infection
    Medical condition: Chronic Hepatitis B Infection
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004862 10047450 Viral hepatitis B LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2022-002268-53 Sponsor Protocol Number: 219288 Start Date*: 2022-12-09
    Sponsor Name:GlaxoSmithKline Research & Development Limited
    Full Title: Phase 3 Multicenter, Randomized, Double-Blind, Study to Assess the Efficacy and Safety of Treatment with Bepirovirsen in HBeAg-negative Nucleos(t)ide Analogue-treated Participants with Chronic Hepa...
    Medical condition: Chronic Hepatitis B 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: ES (Ongoing) IT (Trial now transitioned) FR (Trial now transitioned) PL (Trial now transitioned) DE (Ongoing) GR (Trial now transitioned) HU (Trial now transitioned) BG (Trial now transitioned) RO (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2021-005139-22 Sponsor Protocol Number: 202009 Start Date*: 2022-12-09
    Sponsor Name:GlaxoSmithKline Research & Development Limited
    Full Title: Phase 3 Multicenter, Randomized, Double-Blind, Study to Assess the Efficacy and Safety of Treatment with Bepirovirsen in HBeAg-negative Nucleos(t)ide Analogue-treated Participants with Chronic Hepa...
    Medical condition: Chronic Hepatitis B 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: ES (Ongoing) IT (Trial now transitioned) FR (Trial now transitioned) PL (Trial now transitioned) DE (Ongoing) GR (Trial now transitioned) HU (Trial now transitioned) BG (Trial now transitioned) RO (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2010-021994-35 Sponsor Protocol Number: A4001098 Start Date*: 2011-06-30
    Sponsor Name:ViiV Healthcare UK Limited
    Full Title: A Multicenter, Randomized, Blinded, Placebo Controlled Study To Evaluate The Safety Of Maraviroc In Combination With Other Antiretroviral Agents In HIV-1 Infected Subjects Coinfected With Hepatitis...
    Medical condition: HIV infection
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004862 10020192 HIV-1 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) CZ (Completed) DE (Completed) GB (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2014-004751-31 Sponsor Protocol Number: Heparc-2003 Start Date*: 2015-06-26
    Sponsor Name:Arrowhead Research Corporation
    Full Title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Multi-dose Study to Determine the Depth of Hepatitis B Surface Antigen (HBsAg) Reduction Following Intravenous ARC-520 in Combination wi...
    Medical condition: Chronic Hepatitis B Virus Infection
    Disease: Version SOC Term Classification Code Term Level
    19.1 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: 2014-004145-27 Sponsor Protocol Number: Heparc-2002 Start Date*: 2015-06-26
    Sponsor Name:Arrowhead Pharmaceuticals Inc.
    Full Title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Multi-dose Study to Determine the Depth of Hepatitis B Surface Antigen (HBsAg) Reduction Following Intravenous ARC-520 in Combination wi...
    Medical condition: Chronic Hepatitis B Virus 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: DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2016-000785-37 Sponsor Protocol Number: GS-US-320-1092 Start Date*: 2016-08-26
    Sponsor Name:Gilead Sciences, Inc.
    Full Title: A Randomized, Double-Blind Evaluation of the Pharmacokinetics, Safety, and Antiviral Efficacy of Tenofovir Alafenamide (TAF) in Adolescents with Chronic Hepatitis B Virus Infection
    Medical condition: Chronic Hepatitis B
    Disease: Version SOC Term Classification Code Term Level
    19.0 10021881 - Infections and infestations 10008910 Chronic hepatitis B PT
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA BE (Completed) IT (Prematurely Ended) RO (Trial now transitioned)
    Trial results: (No results available)
    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
    EudraCT Number: 2012-000586-20 Sponsor Protocol Number: GS-US-174-0144 Start Date*: 2013-01-23
    Sponsor Name:Gilead Sciences Inc.
    Full Title: A Randomized, Double-Blind Evaluation of the Antiviral Efficacy, Safety, and Tolerability of Tenofovir Disoproxil Fumarate Versus Placebo in Pediatric Patients with Chronic Hepatitis B Infection
    Medical condition: Chronic Hepatitis B
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10008910 Chronic hepatitis B PT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: PL (Prematurely Ended) BG (Prematurely Ended) Outside EU/EEA RO (Trial now transitioned)
    Trial results: View results
    EudraCT Number: 2009-016357-17 Sponsor Protocol Number: AI463-189 Start Date*: 2010-12-20
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: A Comparative Study of the Antiviral Efficacy and Safety of Entecavir (ETV) versus Placebo in Pediatric Subjects with Chronic Hepatitis B Virus (HBV) Infection who are HBeAg-Positive Revised Pro...
    Medical condition: CHRONIC HEPATITIS B VIRUS,PEDIATRIC
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10008910 Chronic hepatitis B PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) GB (Completed) GR (Completed) BE (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2007-003704-35 Sponsor Protocol Number: GS-US-174-0115 Start Date*: 2008-12-11
    Sponsor Name:Gilead Science Incorporated
    Full Title: A Randomized, Double-Blind Evaluation of the Antiviral Efficacy, Safety, and Tolerability of Tenofovir Disoproxil Fumarate Versus Placebo in Adolescents with Chronic Hepatitis B Infection
    Medical condition: Chronic hepatitis B
    Disease: Version SOC Term Classification Code Term Level
    9.1 10008910 Chronic hepatitis B LLT
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed) BE (Completed) FR (Completed) ES (Completed) BG (Completed) DE (Completed) GR (Prematurely Ended) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2018-002042-36 Sponsor Protocol Number: ABI-H0731-202 Start Date*: 2018-08-06
    Sponsor Name:Assembly Biosciences
    Full Title: A Phase 2a, Multi-center, Double-blind, Placebo-controlled Study Evaluating ABI-H0731 + Entecavir vs Entecavir Alone for the Treatment of Viremic, HBeAg-positive Patients with Chronic Hepatitis B
    Medical condition: Chronic Hepatitis B
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2012-004942-14 Sponsor Protocol Number: CLDT600A2306 Start Date*: 2014-05-09
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A randomized, double-blind, 104-weeks treatment study to evaluate the efficacy, safety, tolerability and pharmacokinetics of telbivudine oral solution and tablets in children and adolescents with c...
    Medical condition: compensated HBeAg-positive and negative chronic hepatitis B virus infection
    Disease: Version SOC Term Classification Code Term Level
    16.1 10021881 - Infections and infestations 10008910 Chronic hepatitis B PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Prematurely Ended) GR (Completed) BG (Prematurely Ended)
    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: 2016-002302-39 Sponsor Protocol Number: RSV-M-301 Start Date*: 2016-09-06
    Sponsor Name:Novavax, Inc.
    Full Title: A Phase 3, Randomized, Observer-Blind, Placebo-Controlled, Group-Sequential Study to Determine the Immunogenicity and Safety of a Respiratory Syncytial Virus (RSV) F Nanoparticle Vaccine with Alumi...
    Medical condition: Respiratory syncytial virus (RSV) is the leading viral cause of severe lower respiratory tract disease in infants and young children worldwide. In industrialized countries, nearly all children have...
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10061603 Respiratory syncytial virus infection PT
    Population Age: In utero, Newborns, Infants and toddlers, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Completed) ES (Completed) IT (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: 2014-001400-22 Sponsor Protocol Number: GS-US-283-1059 Start Date*: 2014-11-25
    Sponsor Name:Gilead Sciences, Inc.
    Full Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-center Study to Evaluate the Safety and Efficacy of GS-9620 for the Treatment of Virally-Suppressed Subjects with Chronic Hepatitis B
    Medical condition: Chronic Hepatitis B (CHB) Infection
    Disease: Version SOC Term Classification Code Term Level
    17.0 10021881 - Infections and infestations 10008910 Chronic hepatitis B PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2018-003167-54 Sponsor Protocol Number: EIG-LNF-011 Start Date*: 2019-06-24
    Sponsor Name:Eiger BioPharmaceuticals, Inc.
    Full Title: A Phase 3, Matrix Design, Partially Double-Blind, Randomized Study of the Efficacy and Safety of 50 mg Lonafarnib/100 mg Ritonavir BID with and without 180 mcg PEG IFN-alfa-2a for 48 Weeks Compared...
    Medical condition: The proposed indication for lonafarnib coadministered with ritonavir is for the treatment of chronic HDV infection. Approximately 5% of HBV-infected individuals are infected with HDV worldwide. Ch...
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004862 10019763 Hepatitis delta LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) GB (GB - no longer in EU/EEA) FR (Completed) BG (Completed) GR (Completed) ES (Ongoing) SE (Completed) IT (Completed) RO (Completed)
    Trial results: (No results available)
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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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