Flag of the European Union EU Clinical Trials Register Help

Clinical trials for Entecavir

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   44334   clinical trials with a EudraCT protocol, of which   7366   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.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     
    58 result(s) found for: Entecavir. Displaying page 1 of 3.
    1  2  3  Next»
    EudraCT Number: 2008-005976-28 Sponsor Protocol Number: ETV-after-HBV-related-LTx Start Date*: 2009-08-19
    Sponsor Name:Hannover Medical School
    Full Title: Prevention of HBV reinfection after liver transplantation using entecavir monotherapy after short-term HBIg administration: A pilot study Version 1.2 2008-09-11 Amendment 2 2009-07-07
    Medical condition: chronic hepatitis B
    Disease: Version SOC Term Classification Code Term Level
    9.1 10052552 Hepatitis B virus LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2006-000453-22 Sponsor Protocol Number: AI463-109 Start Date*: 2007-03-08
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: Study of the Antiviral Activity of Entecavir in Patients Receiving Liver Transplant Due to Chronic Hepatitis B Virus Infection. Revised Protocol 01, incorporating Amendment 02 (Version 1.0 Date 20...
    Medical condition: CHRONIC HEPATITIS B VIRUS,TRANSPLANT
    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) ES (Completed)
    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: 2011-004272-11 Sponsor Protocol Number: 2B Start Date*: 2011-11-30
    Sponsor Name:Erasmus MC
    Full Title: The BOKITO-2B Study: Tenofovir DF Bone and Kidney Toxicity. Incidence and reversibility in HBV-monoinfected patients.
    Medical condition: Chronic hepatitis B
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2008-007296-24 Sponsor Protocol Number: 08/01 Start Date*: 2009-01-21
    Sponsor Name:AISF - ASSOCIAZIONE ITALIANA PER LO STUDIO DEL FEGATO
    Full Title: Multicenter open-label, phase IIB study with 0.5 mg / day Entecavir (BARACLUDE ) in patients with positive HBsAg solid or hematologic malignancies undergoing chemotherapy (ChemET) (ChemET)
    Medical condition: Subject with new diagnosis of solid or haematological cancer in inactive carrier in chronic virus B infected patients
    Disease: Version SOC Term Classification Code Term Level
    9.1 10008910 Chronic hepatitis B LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    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: 2010-019884-12 Sponsor Protocol Number: INFIRE-001 Start Date*: 2010-12-17
    Sponsor Name:Universitätsklinikum Aachen
    Full Title: Induction of Fibrosis Regression regarding Chronic Hepatitis B Infection
    Medical condition: Patients with chronic hepatitis B infection and a relevant grade of fibrosis (histological >= F2)
    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: DE (Prematurely Ended)
    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: 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: 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: 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: 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: 2009-015705-40 Sponsor Protocol Number: AI463203 Start Date*: 2010-04-08
    Sponsor Name:Bristol Myers Squibb International Corporation
    Full Title: Protocol AI463203: A Study of the Safety and Efficacy of Entecavir plus Tenofovir in Adults with Chronic Hepatitis B Virus Infection with Previous Nucleoside/Nucleotide Treatment Failure
    Medical condition: Chronic Hepatitis B Virus Infection
    Disease: Version SOC Term Classification Code Term Level
    12.0 10008910 Chronic hepatitis B LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) IT (Completed) DE (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2021-001003-32 Sponsor Protocol Number: 1 Start Date*: 2021-07-28
    Sponsor Name:Antwerp University Hospital
    Full Title: Controlled Interruption of Nucleos(t)ide Analogue Treatment in Chronic Hepatitis B Infections
    Medical condition: Chronic Hepatitis B Infection
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2006-000422-31 Sponsor Protocol Number: AI 463-111 Start Date*: 2007-07-06
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: Comparative Study of Entecavir vs Adefovir vs the Combination in Lamivudine- Refractory Chronic Hepatitis B Subjects The DEFINE Study Revised Protocol 01
    Medical condition: CHRONIC HEPATITIS B VIRUS
    Disease: Version SOC Term Classification Code Term Level
    9.1 10019731 Hepatitis B LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed) GR (Completed)
    Trial results: View results
    EudraCT Number: 2005-004096-37 Sponsor Protocol Number: GS-US-174-0108 Start Date*: 2006-05-19
    Sponsor Name:Gilead Sciences Incorporated
    Full Title: A Phase 2, Double-Blind, Multi-center, Randomized Study Comparing Tenofovir Disoproxil Fumarate, Emtricitabine Plus Tenofovir Disoproxil Fumarate, and Entecavir in the Treatment of Chronic Hepatiti...
    Medical condition: Chronic Hepatitis B
    Disease: Version SOC Term Classification Code Term Level
    8.1 10008910 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IE (Completed) ES (Completed) GB (Completed) DE (Completed) IT (Completed) GR (Completed)
    Trial results: View results
    EudraCT Number: 2005-003284-22 Sponsor Protocol Number: AI463080 Start Date*: 2007-03-19
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: Randomized, Observational Study of Entecavir to Assess Long-term Outcomes Associated with Nucleoside/Nucleotide Monotherapy for Patients with Chronic HBV Infection: The REALM Study
    Medical condition: CHRONIC HEPATITIS B VIRUS INFECTION
    Disease: Version SOC Term Classification Code Term Level
    8.1 10008910 Chronic hepatitis B LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) DE (Completed) ES (Completed) IT (Completed) PT (Completed) GR (Completed) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2005-005816-26 Sponsor Protocol Number: AI463-028 Start Date*: 2007-08-30
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: Evaluation of the Pharmacokinetics, Safety, Tolerability and Efficacy of Entecavir (ETV) in Pediatric Subjects with Chronic Hepatitis B Virus (HBV) Infection who are HBeAg-Positive. Revised Pro...
    Medical condition: Chronic Hepatitis B Virus (HBV) Infection
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004848 10019743 Hepatitis B virus (HBV) LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed) BE (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2010-018523-26 Sponsor Protocol Number: AOBSMI2ENT001-010 Start Date*: 2010-03-17
    Sponsor Name:AZIENDA OSPEDALIERA SPEDALI CIVILI DI BRESCIA
    Full Title: Immediate versus delayed treatment with Entecavir in patients with active chronic hepatitis B (CHB): impact on liver fibrosis.
    Medical condition: Patients with chronic HBV infection
    Disease: Version SOC Term Classification Code Term Level
    9.1 10008910 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2014-003894-41 Sponsor Protocol Number: ImmunoPeg Start Date*: 2014-11-21
    Sponsor Name:Azienda Ospedaliero-Universitaria di Parma
    Full Title: Effect of a Peg-interferon alfa 2A pulse on HBV-specific T cell responses in chronic hepatitis HBeAg negative patients under long-term nucleos(t)ide treatment
    Medical condition: Chronic hepatitis B 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)
    Trial results: (No results available)
    Download Options:
    Number of Trials to download:
    Download Content:
    Download Format:
    Note, where multi-state trials are shown in search results, selecting "Full Trial details" will download full information for each of the member states/countries involved in the trial.
    1  2  3  Next»
    Query did not match any studies.
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Wed May 07 14:31:52 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA