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Clinical trials for HPN

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   44335   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 ).  
     
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    1 result(s) found for: HPN. Displaying page 1 of 3.
    1  2  3  Next»
    EudraCT Number: 2005-000680-26 Sponsor Protocol Number: Taurine05 Start Date*: 2005-06-27
    Sponsor Name:North west London Hospital Trust
    Full Title: A randomised double blind controlled crossover trial of intravenous taurine supplementation in parenteral nutrition as an effective treatment for reducing hepatobiliary complications in chronic int...
    Medical condition: Complications of intravenous nutrition include cholestatic liver disease. This is one of the main causes of death during long-term home parenteral nutrition (HPN) and a study in 2000 found that 65%...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: (No results available)
    EudraCT Number: 2014-003247-36 Sponsor Protocol Number: HPN-100-005SE Start Date*: 2015-02-10
    Sponsor Name:Hyperion Therapeutics, Inc.
    Full Title: A Phase 2, Fixed-Sequence, Open-Label, Switch-Over Study of the Safety and Tolerability of HPN 100 Compared to Sodium Phenylbutyrate in Children 6–17 Years of Age with Urea Cycle Disorders, with a ...
    Medical condition: Urea Cycle Disorders
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2005-001938-32 Sponsor Protocol Number: HC-G-H-0503 Start Date*: 2007-05-29
    Sponsor Name:B.Braun Melsungen AG
    Full Title: EFFICACY, SAFETY, AND QUALITY OF LIFE OF A LONG-TERM HOME PARENTERAL NUTRITION REGIMEN WITH EITHER LIPIDEM® OR LIPOFUNDIN® MCT A MONO-CENTER, RANDOMIZED, DOUBLE BLIND STUDY
    Medical condition: The trial aims at providing patients with insufficient absorption capacity, that may not be compensated by enteral nutrition, with the required amount of caloric supply. The insufficient absorptio...
    Disease: Version SOC Term Classification Code Term Level
    14.1 10042613 - Surgical and medical procedures 10051284 Parenteral nutrition PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2014-003246-26 Sponsor Protocol Number: HPN-100-005SO Start Date*: 2015-02-10
    Sponsor Name:Hyperion Therapeutics, Inc.
    Full Title: A Phase 2, Fixed-Sequence, Open-Label, Switch-Over Study of the Safety and Tolerability of HPN 100 Compared to Sodium Phenylbutyrate in Children 6–17 Years of Age with Urea Cycle Disorders, with a ...
    Medical condition: Urea Cycle Disorders (UCDs)
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2015-000849-23 Sponsor Protocol Number: HC-G-H-1403 Start Date*: 2017-08-21
    Sponsor Name:B. Braun Melsungen AG
    Full Title: A RANDOMIZED, CONTROLLED, DOUBLE-BLIND, MULTICENTER CLINICAL TRIAL ON HOME PARENTERAL NUTRITION USING AN OMEGA-3 FATTY ACID ENRICHED MCT/LCT LIPID EMULSION
    Medical condition: Chronic intestinal failure
    Disease: Version SOC Term Classification Code Term Level
    20.0 10017947 - Gastrointestinal disorders 10017947 Gastrointestinal disorders SOC
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) GB (GB - no longer in EU/EEA)
    Trial results: View results
    EudraCT Number: 2014-003248-12 Sponsor Protocol Number: HPN-100-012SO Start Date*: 2015-02-10
    Sponsor Name:Hyperion Therapeutics, Inc.
    Full Title: A Switch-Over, Open-Label Study of the Safety, Pharmacokinetics, and Efficacy of HPN-100, Followed by Long-Term Treatment with HPN-100, in Pediatric Subjects under 6 Years of Age with Urea Cycle Di...
    Medical condition: Urea Cycle Disorders (UCDs)
    Disease:
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2014-003249-82 Sponsor Protocol Number: HPN-100-012SE Start Date*: 2015-02-10
    Sponsor Name:Hyperion Therapeutics, Inc.
    Full Title: A Switch-Over, Open-Label Study of the Safety, Pharmacokinetics, and Efficacy of HPN-100, Followed by Long-Term Treatment with HPN-100, in Pediatric Subjects under 6 Years of Age with Urea Cycle Di...
    Medical condition: Urea Cycle Disorders (UCDs)
    Disease:
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2005-000043-28 Sponsor Protocol Number: E05-001 Start Date*: 2005-04-19
    Sponsor Name:ALEXION PHARMACEUTICALS INCORPORATED
    Full Title: A Phase III, Open-Label, Extension Study of Eculizumab in Patients with Transfusion Dependent, Hemolytic Paroxysmal Nocturnal Hemoglobinuria (PNH) Who Have Participated in the TRIUMPH (C04-001), SH...
    Medical condition: paroxysmal nocturnal hemoglobinuria
    Disease: Version SOC Term Classification Code Term Level
    7.0 10034042 PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) IE (Completed) SE (Completed) DE (Completed) ES (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2016-003522-16 Sponsor Protocol Number: RA101495-01.201 Start Date*: 2017-06-20
    Sponsor Name:Ra Pharmaceuticals, Inc.
    Full Title: A PHASE 2 MULTICENTER,OPEN-LABEL, UNCONTROLLED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, EFFICACY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF RA101495 IN SUBJECTS WITH PAROXYSMAL NOCTURNAL HEMOGLO...
    Medical condition: Paroxysmal Nocturnal Hemoglobinuria (PNH)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000012950 10055629 Paroxysmal nocturnal hemoglobinuria LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Completed) GB (Completed) HU (Completed) DK (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2009-010402-11 Sponsor Protocol Number: M07-005 Start Date*: 2012-04-30
    Sponsor Name:ALEXION PHARMACEUTICALS, INC.
    Full Title: AN OPEN-LABEL MULTI-CENTER STUDY OF ECULIZUMAB IN CHILDREN AND ADOLESCENTS WITH A DIAGNOSIS OF PAROXYSMAL NOCTURNAL HEMOGLOBINURIA
    Medical condition: PAROXYSMAL NOCTURNAL HEMOGLOBINURIA
    Disease: Version SOC Term Classification Code Term Level
    14.1 10038359 - Renal and urinary disorders 10034042 Paroxysmal nocturnal haemoglobinuria PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2004-000646-20 Sponsor Protocol Number: C04-001 Start Date*: 2004-09-21
    Sponsor Name:ALEXION PHARMACEUTICALS INCORPORATED
    Full Title: A Hemoglobin Stabilization and Transfusion Reduction Efficacy and Safety Clinical Investigation, Randomized, Multi-Center, Double-Blind, Placebo-Controlled, Using Eculizumab in Paroxysmal Nocturnal...
    Medical condition: paroxysmal nocturnal hemoglobinuria
    Disease: Version SOC Term Classification Code Term Level
    7.0 10034042 PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) IE (Completed) GB (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2016-003523-34 Sponsor Protocol Number: RA101495-01.202 Start Date*: 2017-04-06
    Sponsor Name:Ra Pharmaceuticals, Inc.
    Full Title: A Multicenter, Open-label, Uncontrolled, Extension Study of RA101495 in Subjects with Paroxysmal Nocturnal Hemoglobinuria Who Have Completed a RA101495 Clinical Study
    Medical condition: Paroxysmal Nocturnal Hemoglobinuria (PNH)
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004857 10055629 Paroxysmal nocturnal hemoglobinuria LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Completed) HU (Completed) DK (Prematurely Ended) GB (GB - no longer in EU/EEA)
    Trial results: View results
    EudraCT Number: 2004-002795-42 Sponsor Protocol Number: C04-002 Start Date*: 2005-02-16
    Sponsor Name:ALEXION PHARMACEUTICALS INCORPORATED
    Full Title: Safety in Hemolytic PNH Patients Treated with Eculizumab: A Multi-center Open-label Research Design Study
    Medical condition: paroxysmal nocturnal hemoglobinuria
    Disease: Version SOC Term Classification Code Term Level
    7.0 10034042 PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) IE (Completed) DE (Completed) GB (Completed) IT (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2020-000501-93 Sponsor Protocol Number: BCX9930-201 Start Date*: 2020-09-29
    Sponsor Name:BioCryst Pharmaceuticals Inc
    Full Title: A Phase 2, Open-Label Study to Evaluate the Long-term Safety of Oral BCX9930 in Subjects with Paroxysmal Nocturnal Hemoglobinuria (PNH)
    Medical condition: Paroxysmal Nocturnal Hemoglobinuria (PNH)
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004857 10055629 Paroxysmal nocturnal hemoglobinuria LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) AT (Completed) DK (Prematurely Ended) IT (Completed)
    Trial results: View results
    EudraCT Number: 2019-003829-18 Sponsor Protocol Number: ALXN2040-PNH-301 Start Date*: 2020-11-04
    Sponsor Name:Alexion Pharmaceuticals Inc.
    Full Title: A Phase 3 Study of Danicopan (ALXN2040) as Add-on Therapy to a C5 Inhibitor (Eculizumab or Ravulizumab) in Patients with Paroxysmal Nocturnal Hemoglobinuria Who Have Clinically Evident Extravascula...
    Medical condition: Patients with Paroxysmal Nocturnal Hemoglobinuria Who Have Clinically Evident Extravascular Hemolysis (EVH)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10038359 - Renal and urinary disorders 10034042 Paroxysmal nocturnal haemoglobinuria PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) DE (Completed) GB (GB - no longer in EU/EEA) NL (Completed) PL (Completed) IT (Completed) GR (Completed)
    Trial results: View results
    EudraCT Number: 2021-004253-22 Sponsor Protocol Number: ALXN2040-PNH-303 Start Date*: 2022-07-04
    Sponsor Name:Alexion Pharmaceuticals Inc.
    Full Title: A Long-term Extension (LTE) Study to Characterize the Safety and Efficacy of Danicopan as an Add-on Therapy to a Complement Component 5 Inhibitor (C5i) in Patients with Paroxysmal Nocturnal Hemoglo...
    Medical condition: Patients with Paroxysmal Nocturnal Hemoglobinuria
    Disease: Version SOC Term Classification Code Term Level
    21.1 10038359 - Renal and urinary disorders 10034042 Paroxysmal nocturnal haemoglobinuria PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing) FR (Trial now transitioned) IT (Trial now transitioned) GR (Trial now transitioned) PL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2017-002820-26 Sponsor Protocol Number: ALXN1210-PNH-304 Start Date*: 2017-11-24
    Sponsor Name:Alexion Pharmaceuticals Incorporated
    Full Title: A Phase 3, Open-Label Study of ALXN1210 in Children and Adolescents with Paroxysmal Nocturnal Hemoglobinuria (PNH)
    Medical condition: Paroxysmal Nocturnal Hemoglobinuria (PNH)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10038359 - Renal and urinary disorders 10034042 Paroxysmal nocturnal haemoglobinuria PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) NL (Completed) FR (Completed) NO (Completed)
    Trial results: View results
    EudraCT Number: 2021-006776-17 Sponsor Protocol Number: BCX9930-205 Start Date*: 2023-01-10
    Sponsor Name:BioCryst Pharmaceuticals Inc
    Full Title: An Open-label Study to Evaluate the Long-term Safety of BCX9930 Monotherapy in Subjects with Paroxysmal Nocturnal Hemoglobinuria Who Previously Received BCX9930 in a BioCryst sponsored Study
    Medical condition: Paroxysmal Nocturnal Hemoglobinuria
    Disease: Version SOC Term Classification Code Term Level
    21.1 10038359 - Renal and urinary disorders 10055629 Paroxysmal nocturnal hemoglobinuria LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: HU (Completed) FR (Completed) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2020-004385-19 Sponsor Protocol Number: CLNP023C12001B Start Date*: 2021-07-15
    Sponsor Name:Novartis Pharma AG
    Full Title: An open label, multicenter roll-over extension program (REP) to characterize the long-term safety and tolerability of iptacopan (LNP023) in patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) w...
    Medical condition: Paroxysmal Nocturnal Hemoglobinuria (PNH)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10038359 - Renal and urinary disorders 10034042 Paroxysmal nocturnal haemoglobinuria PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: LT (Trial now transitioned) IT (Trial now transitioned) ES (Ongoing) FR (Trial now transitioned) CZ (Trial now transitioned) NL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2017-001405-32 Sponsor Protocol Number: IMIS2017-02 Start Date*: Information not available in EudraCT
    Sponsor Name:Institut des Maladies Génétiques - Imagine
    Full Title: A Monocentric Single-arm study to characterize the long-term safety, efficacy, and pharmacodynamic of GLP-2 analog (Revestive®) in the management of short bowel syndrome pediatric patients on home-...
    Medical condition: Short Bowel Syndrom
    Disease: Version SOC Term Classification Code Term Level
    20.0 10017947 - Gastrointestinal disorders 10049416 Short-bowel syndrome PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: FR (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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