Flag of the European Union EU Clinical Trials Register Help

Clinical trials for daclatasvir

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   44336   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
     
    30 result(s) found for: daclatasvir. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2015-002272-24 Sponsor Protocol Number: M13-594 Start Date*: 2016-01-26
    Sponsor Name:AbbVie Deutschland GmbH & Co. KG
    Full Title: A Randomized, Open-Label, Active-Controlled, Multicenter Study to Compare Efficacy and Safety of ABT-493/ABT-530 to Sofosbuvir Co-Administered with Daclatasvir in Adults with Chronic Hepatitis C Vi...
    Medical condition: Chronic HCV Genotype 3 Infection
    Disease: Version SOC Term Classification Code Term Level
    18.1 10021881 - Infections and infestations 10008912 Chronic hepatitis C PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) GB (Completed) SE (Completed)
    Trial results: View results
    EudraCT Number: 2013-002726-23 Sponsor Protocol Number: TMC435HPC3016 Start Date*: 2013-12-12
    Sponsor Name:Janssen R&D, Ireland
    Full Title: Phase 2, Open-Label Study to Investigate the Pharmacokinetics, Efficacy, Safety, and Tolerability of the Combination of Simeprevir (TMC435), Daclatasvir (BMS-790052) and Ribavirin (RBV) in Patients...
    Medical condition: Hepatitis C Virus (HCV) genotype-1b Infection
    Disease: Version SOC Term Classification Code Term Level
    16.0 10021881 - Infections and infestations 10019744 Hepatitis C PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2014-002808-25 Sponsor Protocol Number: AI444-281 Start Date*: 2015-04-16
    Sponsor Name:Academic Medical Center Amsterdam
    Full Title: Immune phenotyping in chronic hepatitis C patients treated with Sofosbuvir and Daclatasvir combination with or without Ribavirin for 12 or 24 weeks -SODA study
    Medical condition: Chronic hepatitis C
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2017-003338-94 Sponsor Protocol Number: AI444-423 Start Date*: 2018-05-09
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: Open-Label, Single-Arm Trial to Evaluate the Pharmacokinetics, Safety and Efficacy of Daclatasvir (DCV) in Combination with Sofosbuvir (SOF) in Children from 3 to less than 18 Years of Age with GT-...
    Medical condition: Chronic Hepatitis C (CHC) Infection
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021881 - Infections and infestations 10008912 Chronic hepatitis C PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) ES (Completed) PL (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2011-005287-21 Sponsor Protocol Number: AI444-046 Start Date*: 2012-02-09
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: A Long-Term Follow-up Study of Subjects Who Participated in a Clinical Trial in Which Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052) Was Administered for the Treatment of Chronic Hepatiti...
    Medical condition: Chronic Hepatitis C
    Disease: Version SOC Term Classification Code Term Level
    17.1 10021881 - Infections and infestations 10008912 Chronic hepatitis C PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) IE (Completed) SE (Completed) IT (Completed) GB (Completed) DK (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2013-002991-42 Sponsor Protocol Number: HCV-13-01 Start Date*: 2013-12-19
    Sponsor Name:Foundation for Liver Research
    Full Title: Effect of ASV and DCV therapy on the quality of immune status in chronic HCV patients Investigator initiated research proposal nr. AI447-108
    Medical condition: Chronic hepatitis C
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2019-001431-31 Sponsor Protocol Number: AT-01B-002 Start Date*: 2019-05-20
    Sponsor Name:Atea Pharmaceuticals, Inc.
    Full Title: A Phase 2 Study Assessing the Safety and Efficacy of AT-527 in Combination with Daclatasvir in Subjects with Chronic HCV Infection
    Medical condition: HCV-Infected subjects
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004862 10047457 Viral hepatitis C LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2014-003413-28 Sponsor Protocol Number: TMC435HPC2019 Start Date*: 2014-12-05
    Sponsor Name:Janssen-Cilag International NV
    Full Title: A Phase 2, Open-label Study to Investigate the Efficacy and Safety of the Combination of Simeprevir and Daclatasvir in Chronic Hepatitis C Genotype 1b-Infected Subjects With Advanced Liver Disease
    Medical condition: Hepatitis C Virus (HCV) genotype-1b Infection
    Disease: Version SOC Term Classification Code Term Level
    17.0 10021881 - Infections and infestations 10019744 Hepatitis C PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) GB (Completed) DE (Completed) BE (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2014-005310-28 Sponsor Protocol Number: AI444-326 Start Date*: 2015-02-13
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: Open-Label, Randomized Study of Daclatasvir, Sofosbuvir, and Ribavirin for 12 vs. 16 weeks in Treatment-Naïve and Treatment-Experienced Patients with Genotype 3 Chronic Hepatitis C Infection with C...
    Medical condition: Genotype 3 Chronic Hepatitis C infection with Compensated Advanced Fibrosis/Cirrhosis (F3/F4)
    Disease: Version SOC Term Classification Code Term Level
    18.0 10021881 - Infections and infestations 10008912 Chronic hepatitis C PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: View results
    EudraCT Number: 2011-004885-14 Sponsor Protocol Number: AI452-017 Start Date*: 2012-11-20
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: A Phase 3, Randomized, Double-Blind, Controlled Study Evaluating the Efficacy and Safety of Peginterferon Lambda-1a, with and without Daclatasvir, Compared to Peginterferon Alfa-2a, Each in Combina...
    Medical condition: Chronic Hepatitis C
    Disease: Version SOC Term Classification Code Term Level
    16.0 10021881 - Infections and infestations 10008912 Chronic hepatitis C PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) BE (Completed) FI (Completed) NL (Completed) IT (Completed) GR (Completed)
    Trial results: View results
    EudraCT Number: 2011-004237-14 Sponsor Protocol Number: AI444-052 Start Date*: 2012-02-09
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: A Phase 3 Evaluation of BMS-790052 (Daclatasvir) Compared with Telaprevir in Combination with Peg-Interferon Alfa-2a and Ribavirin in Treatment-Naive Patients with Chronic Hepatitis-C Revised Prot...
    Medical condition: Chronic Hepatitis C
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10008912 Chronic hepatitis C PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) AT (Completed) ES (Completed) GB (Completed) IT (Completed) DK (Completed)
    Trial results: View results
    EudraCT Number: 2013-002468-20 Sponsor Protocol Number: AI443-102 Start Date*: 2013-12-13
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: A Phase 3 Evaluation of a daclatasvir/asunaprevir/BMS-791325 Fixed Dose Combination in Non-cirrhotic Subjects with Genotype 1 Chronic Hepatitis C
    Medical condition: HEPATITIS C VIRUS
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004848 10072848 Hepatitis C virus genotype 1 positive LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: View results
    EudraCT Number: 2013-002458-66 Sponsor Protocol Number: AI443-113 Start Date*: 2013-12-13
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: A Phase 3 Evaluation of a daclatasvir/asunaprevir/BMS-791325 Fixed Dose Combination in Subjects with Genotype 1 Chronic Hepatitis C and Compensated Cirrhosis
    Medical condition: HEPATITIS C VIRUS
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004848 10072848 Hepatitis C virus genotype 1 positive LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: View results
    EudraCT Number: 2011-005409-65 Sponsor Protocol Number: AI452-021 Start Date*: 2013-01-18
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: A Phase 3 Evaluation of Daclatasvir in Combination with Peginterferon Lambda-1a and Ribavirin (RBV) or Telaprevir in Combination with Peginterferon Alfa-2a and RBV in Patients with Chronic Hepatiti...
    Medical condition: Chronic Hepatitis C Virus Infection (Genotype 1b)
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004862 10008912 Chronic hepatitis C LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) IT (Completed) DE (Completed) PL (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2012-000070-28 Sponsor Protocol Number: AI444-062 Start Date*: 2012-08-13
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: A Phase 2, Open-Label Study of Daclatasvir (BMS-790052) and TMC435 in Combination With or Without Ribavirin (RBV) For Treatment-Naive Subjects or Null Responders to Prior Peginterferon Alfa (PegIFN...
    Medical condition: Chronic Hepatitis C
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10008912 Chronic hepatitis C LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) DE (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2011-005422-21 Sponsor Protocol Number: AI447-029 Start Date*: 2012-06-13
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: A Phase 3, Open-Label Study with Asunaprevir and Daclatasvir Plus Peginterferon Alfa-2a (Pegasys) and Ribavirin (Copegus) (P/R) (QUAD) for Subjects Who Are Null or Partial Responders to Peginterfer...
    Medical condition: Chronic Hepatitis C Virus Infection (Genotypes 1 and 4)
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10008912 Chronic hepatitis C PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) DE (Completed) NL (Completed) ES (Completed) DK (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2012-003280-22 Sponsor Protocol Number: AI452-032 Start Date*: 2013-08-13
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: Phase 3 open label study evaluating the efficacy and safety of pegylated interferon lambda-1a, in combination with ribavirin and daclatasvir, for treatment of chronic HCV infection with treatment n...
    Medical condition: Chronic Hepatitis C Virus (HCV) Infection (Genotypes 1, 2, 3, 4)
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10008912 Chronic hepatitis C PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) BE (Completed) IT (Completed) DE (Completed) ES (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2011-005446-35 Sponsor Protocol Number: AI447-028 Start Date*: 2012-07-12
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: A Phase 3 Study with Asunaprevir and Daclatasvir (DUAL) for Null or Partial Responders to Peginterferon Alfa and Ribavirin (P/R), Intolerant or Ineligible to P/R Subjects and Treatment- Naive Subje...
    Medical condition: HEPATITIS C VIRUS
    Disease: Version SOC Term Classification Code Term Level
    16.0 10021881 - Infections and infestations 10008912 Chronic hepatitis C PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IE (Completed) AT (Completed) GB (Completed) NL (Completed) ES (Completed) DE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2014-004250-34 Sponsor Protocol Number: TMC435HPC2018 Start Date*: 2015-05-11
    Sponsor Name:Janssen R&D Ireland
    Full Title: A Phase 2, Open-label, Single-arm Study to Investigate the Efficacy, Safety, Tolerability and Pharmacokinetics of 12 Weeks Treatment With Simeprevir and Daclatasvir in Subjects With Chronic Hepatit...
    Medical condition: Hepatitis C Virus (HCV) genotype-1b and 4 Infection
    Disease: Version SOC Term Classification Code Term Level
    17.1 10021881 - Infections and infestations 10019744 Hepatitis C PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Prematurely Ended)
    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
    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  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-Mon May 19 09:34:23 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA