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Clinical trials for Hepatitis D

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   44339   clinical trials with a EudraCT protocol, of which   7369   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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    381 result(s) found for: Hepatitis D. Displaying page 6 of 20.
    EudraCT Number: 2011-002413-11 Sponsor Protocol Number: PRI01C Start Date*: 2012-02-07
    Sponsor Name:Sanofi Pasteur MSD S.N.C
    Full Title: A phase III open-label randomised study, to evaluate the immunogenicity and safety of the concomitant administration of V419 (PR5I) given at 2, 3 and 4 months of age with two types of meningococcal...
    Medical condition: PR5I is developed to provide active immunization against diphtheria, tetanus, pertussis, poliomyelitis (caused by poliovirus Types 1, 2 and 3), invasive disease caused by Haemophilus influenza ty...
    Disease: Version SOC Term Classification Code Term Level
    14.1 10042613 - Surgical and medical procedures 10054183 Tetanus immunization LLT
    14.1 10022891 - Investigations 10019743 Hepatitis B virus (HBV) LLT
    14.1 10042613 - Surgical and medical procedures 10054181 Hepatitis B immunization LLT
    14.1 10042613 - Surgical and medical procedures 10069593 Pertussis immunization LLT
    14.1 10042613 - Surgical and medical procedures 10054180 Diphtheria immunization LLT
    14.1 10042613 - Surgical and medical procedures 10053386 Poliomyelitis vaccine LLT
    14.1 10042613 - Surgical and medical procedures 10069543 Hemophilus influenzae type b immunization LLT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2019-004978-26 Sponsor Protocol Number: 73763989PAHPB2005 Start Date*: 2020-10-12
    Sponsor Name:Janssen-Cilag International NV
    Full Title: A Phase 2, randomized, open-label, multicenter study to evaluate efficacy, pharmacokinetics, safety, and tolerability of response-guided treatment with JNJ-73763989 + JNJ-56136379 + nucleos(t)ide a...
    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: GB (GB - no longer in EU/EEA) FR (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2009-016635-36 Sponsor Protocol Number: 113615 Start Date*: 2010-03-04
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase II, open-label, randomised, multicentre study to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals’ DTPa-HBV-IPV/Hib-MenC-TT vaccine, when given to healthy infants at 2,...
    Medical condition: Primary and booster immunisation of healthy infants in the first year of life against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, Haemophilus influenzae type b, serogroup C meningoc...
    Disease: Version SOC Term Classification Code Term Level
    12.1 10043376 Tetanus LLT
    12.1 10013023 Diphtheria LLT
    12.1 10034738 Pertussis LLT
    12.1 10019731 Hepatitis B LLT
    12.1 10036012 Poliomyelitis LLT
    12.1 10018952 Haemophilus influenzae infection LLT
    12.1 10027274 Meningococcal infection LLT
    12.1 10067470 Rotavirus infection LLT
    12.1 10061353 Pneumococcal infection LLT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: FR (Completed) DE (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: 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: 2012-004221-25 Sponsor Protocol Number: PRI02C Start Date*: 2013-03-12
    Sponsor Name:Sanofi Pasteur MSD
    Full Title: A phase 3 open-label study to evaluate the immunogenicity and safety of a mixed (HEXA/PENTA/HEXA) primary series schedule that includes V419 (PR5I) at 2 and 6 months of age and Pediacel® at 4 month...
    Medical condition: Healthy infants greater than or equal to 46 days and less than or equal to 74 days of age on the day of inclusion
    Disease: Version SOC Term Classification Code Term Level
    16.0 100000004865 10054187 Polio immunization LLT
    16.0 100000004865 10069543 Hemophilus influenzae type b immunization LLT
    16.0 100000004865 10069593 Pertussis immunization LLT
    16.0 100000004865 10054181 Hepatitis B immunization LLT
    16.0 100000004865 10054180 Diphtheria immunization LLT
    16.0 100000004865 10054183 Tetanus immunization LLT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: View results
    EudraCT Number: 2015-001449-93 Sponsor Protocol Number: 110031 Start Date*: 2015-06-17
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase II, observer-blind follow-up study with two groups to assess the reactogenicity and immunogenicity of GlaxoSmithKline (GSK) Biologicals’ 10-valent pneumococcal conjugate vaccine (GSK1024850...
    Medical condition: Healthy volunteers (Booster immunization of healthy children previously primed with three doses of pneumococcal conjugate vaccine or a two-dose catch-up immunization in unprimed children previously...
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2009-012460-14 Sponsor Protocol Number: 112980 Start Date*: 2010-05-03
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase II, open-label, randomised study to assess the safety and immunogenicity of a birth dose of GSK Biologicals’ reduced-antigen-content tri-component pertussis vaccine followed by routine paed...
    Medical condition: Primary and booster immunisation of healthy infants in the first two years of life against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, Haemophilus influenzae type b, rotavirus and p...
    Disease: Version SOC Term Classification Code Term Level
    12.1 10043376 Tetanus LLT
    12.1 10013023 Diphtheria LLT
    12.1 10034738 Pertussis LLT
    12.1 10019731 Hepatitis B LLT
    12.1 10036012 Poliomyelitis LLT
    12.1 10018952 Haemophilus influenzae infection LLT
    12.1 10067470 Rotavirus infection LLT
    12.1 10061353 Pneumococcal infection LLT
    Population Age: Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: NL (Completed) GB (Prematurely Ended) BE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2019-002585-12 Sponsor Protocol Number: A3L00057 Start Date*: 2020-08-03
    Sponsor Name:SANOFI PASTEUR
    Full Title: Immunogenicity and Safety of DTaP-IPV-HB-PRP~T Combined Vaccine Given at 3, 5, and 12 Monhs of Age Concomitantly or Sequentially 4CMenB Vaccine in Italian Infants
    Medical condition: Haemophilus influenzae type b immunisation
    Disease: Version SOC Term Classification Code Term Level
    21.1 10042613 - Surgical and medical procedures 10054181 Hepatitis B immunization LLT
    21.1 10042613 - Surgical and medical procedures 10069533 Haemophilus influenzae type b immunisation PT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: IT (Completed) FI (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
    EudraCT Number: 2012-001344-22 Sponsor Protocol Number: 116640 Start Date*: 2013-02-19
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase II, randomised, single-blind study to develop read-outs aimed at detecting and characterising the early and adaptive immune responses and to evaluate the kinetics of the early response and ...
    Medical condition: Healthy volunteers (Hepatitis B surface antigen (HBsAg) vaccine administered in hepatitis B virus (HBV) naive adult subjects aged between 18 and 45 years old, inclusive, in good general health.)
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: BE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2011-000943-26 Sponsor Protocol Number: 115375 Start Date*: 2011-05-12
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase IV, open-label, study to assess the antibody persistence in healthy 5-year-old children, previously vaccinated at 3, 5 and 11months of age with GSK Biologicals’ DTPa-HBV-IPV/Hib or DTPa-IPV...
    Medical condition: Healthy volunteers (Immunogenicity of the DTPa-HBV-IPV/Hib and DTPa-IPV/Hib vaccines in terms of persistence of antibodies to diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B and Hib vacc...
    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: Children, Under 18 Gender: Male, Female
    Trial protocol: SE (Completed) NO (Completed)
    Trial results: View results
    EudraCT Number: 2006-002543-92 Sponsor Protocol Number: PO3523 Start Date*: 2007-01-31
    Sponsor Name:Schering-Plough Research Institute
    Full Title: A Safety and Efficacy Study of SCH 503034 in Previously Untreated Subjects With Chronic Hepatitis C Infected With Genotype 1
    Medical condition: Chronic Hepatitis C
    Disease: Version SOC Term Classification Code Term Level
    8.1 10008912 Chronic hepatitis C LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed) FR (Completed) IT (Completed) NL (Completed) PT (Prematurely Ended) BE (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: 2016-001038-91 Sponsor Protocol Number: NL57115 Start Date*: 2016-11-18
    Sponsor Name:Leiden university medical centre
    Full Title: A randomised, open-label clinical trial assessing the efficacy and safety of mycophenolate mofetil versus azathioprine for induction of remission in treatment naive autoimmune hepatitis
    Medical condition: Autoimmune hepatitis
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing) BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2006-004129-27 Sponsor Protocol Number: X06-MMRV-302 Start Date*: 2006-12-13
    Sponsor Name:Sanofi Pasteur MSD
    Full Title: An open, randomised, comparative, multicentre study of the immunogenicity and safety of concomitant versus separate administration of a combined measles, mumps, rubella and varicella live vaccine (...
    Medical condition: The study will involve healthy children.
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2012-005525-75 Sponsor Protocol Number: SSAT052 Start Date*: 2013-07-16
    Sponsor Name:St Stephen's AIDS Trust
    Full Title: An open label, randomised, pilot trial of pegylated interferon, ribavirin and telaprevir versus pegylated interferon and ribavirin alone in the response guided treatment of acute hepatitis C genoty...
    Medical condition: Acute hepatitis C infection
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2010-019057-17 Sponsor Protocol Number: SPC3649-203 Start Date*: 2010-07-13
    Sponsor Name:Santaris Pharma A/S
    Full Title: A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Ascending Multiple-Dose Study to Assess Safety, Tolerability, Pharmacokinetics and Antiviral Activity of SPC3649 (miravirsen) Administered ...
    Medical condition: Patients infected with chronic hepatitis C
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Completed) DE (Completed) SK (Completed) PL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2012-005547-24 Sponsor Protocol Number: HXM01C Start Date*: 2013-03-07
    Sponsor Name:Sanofi Pasteur MSD
    Full Title: A phase III open-label randomised study to evaluate the immunogenicity and safety of the concomitant administration of a new Hexavalent DTaP-IPV-HepB-PRP-T combined vaccine (Hexavalent vaccine) giv...
    Medical condition: Healthy infants 46 to 74 days of age (both inclusive)
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004865 10054187 Polio immunization LLT
    17.0 100000004865 10069543 Hemophilus influenzae type b immunization LLT
    17.0 100000004865 10069593 Pertussis immunization LLT
    17.0 100000004865 10054181 Hepatitis B immunization LLT
    17.0 100000004865 10054180 Diphtheria immunization LLT
    17.0 100000004865 10054183 Tetanus immunization LLT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: FI (Completed)
    Trial results: View results
    EudraCT Number: 2015-003562-90 Sponsor Protocol Number: VHCRP1405 Start Date*: 2016-06-17
    Sponsor Name:The Kirby Institute - UNSW Australia
    Full Title: A phase IV open-label, multicentre, international trial of paritaprevir/ritonavir, ombitasvir, dasabuvir with or without ribavirin for people with chronic hepatitis C virus genotype 1 infection and...
    Medical condition: Chronic hepatitis C virus genotype 1 infection
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004848 10072844 Hepatitis C virus genotype 1a positive LLT
    19.0 100000004848 10072845 Hepatitis C virus genotype 1b positive LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (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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