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Clinical trials for Telbivudine

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
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  • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
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    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 ).  
     
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    24 result(s) found for: Telbivudine. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2004-004274-87 Sponsor Protocol Number: NV-02B-022 / CLDT600A2303 Start Date*: 2005-09-30
    Sponsor Name:Novartis Pharma Services AG
    Full Title: An Open Label Trial of Telbivudine (LdT) in Adults with Chronic Hepatitis B Previously Treated in Idenix-Sponsored Telbivudine Studies
    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: DE (Completed) GB (Completed) ES (Completed) CZ (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2016-004825-17 Sponsor Protocol Number: preTopic17 Start Date*: 2017-12-06
    Sponsor Name:Charité Universitätsmedizin Berlin
    Full Title: A Proof-of-concept study to investigate the Efficacy of Telbivudine Over Placebo in patients with Parvovirus-associated Inflammatory Cardiomyopathy
    Medical condition: Parvovirus B19-induced inflammatory cardiomyopathy
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    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: 2004-003754-26 Sponsor Protocol Number: NV-02B-019 Start Date*: 2005-05-25
    Sponsor Name:Idenix Pharmaceuticals, Inc.
    Full Title: A Randomized Trial of Switching Antiviral Therapy from Lamivudine to Telbivudine (LdT) vs. Continued Lamivudine Treatment in Adults with Chronic Hepatitis B
    Medical condition: chronic hepatitis B
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) GB (Completed) ES (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2004-000443-17 Sponsor Protocol Number: NV-02B-011 Start Date*: 2004-09-26
    Sponsor Name:Idenix Pharmaceuticals, Inc.
    Full Title: A Randomized, Double-Blind Trial of Telbivudine (LdT) versus Lamivudine in Adults with Decompensated Chronic Hepatitis B and Evidence of Cirrhosis
    Medical condition: Decompensated Chronic Hepatitis B and Evidence of Cirrhosis
    Disease:
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) LV (Completed)
    Trial results: View results
    EudraCT Number: 2016-001444-20 Sponsor Protocol Number: CLDT600ACN03 Start Date*: 2016-05-18
    Sponsor Name:Beijing Novartis Pharma Co., Ltd.
    Full Title: An Open-label, Single-arm, Multicenter, Phase IV, 52-week Study to Evaluate the Efficacy and Safety of Telbivudine 600mg Tablets in Chinese Patients with Chronic Hepatitis B
    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, Adults, Elderly Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2010-022627-29 Sponsor Protocol Number: IIR-HBV-2010 Start Date*: 2011-03-29
    Sponsor Name:OSPEDALE POLICLINICO S. MATTEO
    Full Title: Innate immune responses in patients with chronic hepatitis B treated with Sebivo (telbivudine)
    Medical condition: Chronic HBV
    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: 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: 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: 2007-006218-40 Sponsor Protocol Number: CLDT600A2104 Start Date*: 2008-09-02
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A Phase I, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics and Safety of Telbivudine (LdT) in Children and Adolescents with Chronic Hepatitis B Virus Infection
    Medical condition: Chronic hepatitis B
    Disease: Version SOC Term Classification Code Term Level
    9.1 10008910 Chronic hepatitis B LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: BE (Prematurely Ended) DE (Prematurely Ended) GB (Prematurely Ended) BG (Prematurely Ended) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2011-002812-10 Sponsor Protocol Number: PADD-ON Start Date*: 2012-01-03
    Sponsor Name:University Medical Center of the Johannes Gutenberg University Mainz
    Full Title: A prospective, randomised, open-label phase IIb clinical trial assessing the effect of pegylated Interferon alfa-2a (Pegasys®) 180 µg once weekly for 48 weeks in addition to an ongoing nucelos(t)id...
    Medical condition: Patients with chronic HBeAg-negative hepatitis B with a stable oral antiviral treatment (not containing telbivudine) and a fully suppressed viral load for at least 12 months (below limit of detecti...
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000109834 10019738 Hepatitis B positive LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2017-001647-12 Sponsor Protocol Number: ARB-001467-003 Start Date*: 2018-02-06
    Sponsor Name:Arbutus Biopharma Corporation
    Full Title: A Phase 2a, Open-Label, Study Evaluating the Safety and Anti-Viral Activity of ARB-001467 in Non-Cirrhotic, HBeAg-Negative Subjects with Chronic HBV Infection (Genotype A or B) in Combination with ...
    Medical condition: Hepatitis B virus e-antigen (HBeAg)-negative subjects with chronic hepatitis B virus infection (CHB)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004848 10054283 HBV DNA detectable LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Prematurely Ended) PL (Completed)
    Trial results: View results
    EudraCT Number: 2007-004845-14 Sponsor Protocol Number: CLDT600A2410 Start Date*: 2008-03-12
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A single-arm, multinational, two year study evaluating the efficacy and safety of lead-in telbivudine for 24 weeks with or without tenofovir treatment intensification in adult patients with HBeAg-p...
    Medical condition: Treatment of adult patients with HBeAg-positive chronic hepatitis B
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10008910 Chronic hepatitis B LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    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: 2019-000896-17 Sponsor Protocol Number: SBP-9200-HBV-206 Start Date*: 2019-05-20
    Sponsor Name:Spring Bank Pharmaceuticals, Inc.
    Full Title: A PHASE 2, EXPLORATORY STUDY EVALUATING THE SAFETY AND ANTIVIRAL EFFICACY OF INARIGIVIR SOPROXIL IN NON-CIRRHOTIC, HEPATITIS B e ANTIGEN NEGATIVE SUBJECTS INFECTED WITH CHRONIC HEPATITIS B VIRUS AN...
    Medical condition: Chronic HBV-infected, HBeAg-negative subjects, who are non-cirrhotic and meet the cohort-specific criteria. Criteria for the planned cohorts are as follows: Cohort 1 Subjects who have been on NUC t...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    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: 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: 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: 2010-019367-11 Sponsor Protocol Number: ANRS HB 06 Start Date*: 2010-08-30
    Sponsor Name:ANRS
    Full Title: ANRS HB 06 PEGAN Essai de phase III, randomisé, multicentrique, sans insu, évaluant à S96 la perte de l’Ag HBs suite à un traitement de 48 semaines par l’interféron pégylé alpha 2a chez des patient...
    Medical condition: Cette étude va évaluer la perte de l’Ag HBs lors d’un traitement par l’interféron pégylé alpha-2a pendant 48 semaines chez des patients ayant une hépatite B chronique (AgHBe négatif), et une charge...
    Disease: Version SOC Term Classification Code Term Level
    12.1 10008910 Chronic hepatitis B LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Ongoing)
    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
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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
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