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Clinical trials for Home Parenteral Nutrition

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   43881   clinical trials with a EudraCT protocol, of which   7295   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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    15 result(s) found for: Home Parenteral Nutrition. Displaying page 1 of 1.
    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: 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: 2019-002587-28 Sponsor Protocol Number: 2019-5165 Start Date*: 2020-02-25
    Sponsor Name:Radboudumc
    Full Title: ABSORB 2:An exploratie study determining the oral antibiotic drug absorption in patients with short bowel syndrome.
    Medical condition: short bowel syndrome, home parenteral nutrition
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: View results
    EudraCT Number: 2019-004297-26 Sponsor Protocol Number: C19-29 Start Date*: 2020-04-17
    Sponsor Name:Institut National de la Santé et de la Recherche Médicale (INSERM)
    Full Title: Prophylactic treatment of the ductus arteriosus in preterm infants by acetaminophen
    Medical condition: Patent ductus arteriosus
    Disease:
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: FR (Ongoing) EE (Ongoing) IE (Restarted) FI (Ongoing) BE (Ongoing) PT (Restarted) SE (Ongoing) HU (Ongoing) DK (Completed) GB (Not Authorised) NO (Completed) AT (Ongoing) GR (Ongoing) PL (Ongoing) IT (Ongoing)
    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)
    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: 2022-004195-42 Sponsor Protocol Number: FIT-05 Start Date*: Information not available in EudraCT
    Sponsor Name:Elgan Pharma Ltd
    Full Title: A Multi-center, Double-Blind, Randomized, Two-Arm, Parallel-Group, Placebo Controlled Basket Study to Assess the Safety of ELGN-2112 in Populations of Interest
    Medical condition: Gastro-intestinal malabsorption due to gastro-intestinal immaturity in preterm infants.
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004856 10025479 Malabsorption syndrome LLT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: FR (Ongoing) SE (Ongoing) ES (Ongoing) NL (Ongoing) AT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2021-004890-29 Sponsor Protocol Number: FIT-PIV Start Date*: 2023-03-09
    Sponsor Name:Elgan Pharma Ltd
    Full Title: A Multi-center, Double-Blind, Randomized, Two-Arm, Parallel-Group, Placebo Controlled Study to Assess the Efficacy and Safety of ELGN-2112 on Intestinal Malabsorption in Preterm Infants
    Medical condition: Gastro-intestinal malabsorption due to gastro-intestinal immaturity in preterm infants.
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004856 10025479 Malabsorption syndrome LLT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: FR (Ongoing) ES (Ongoing) SE (Ongoing) NL (Ongoing) AT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2018-004419-32 Sponsor Protocol Number: PMS-2018-002 Start Date*: 2019-10-03
    Sponsor Name:Pharmascience Inc.
    Full Title: A Phase IIa, Proof of Concept, Randomized, Double-Blind, Dose-Finding, Cross-Over Study of the Efficacy, Safety and Tolerability of a New Enteric-Coated Cholestyramine Capsule in Adult Short Bowel ...
    Medical condition: Bile-acid induced diarrhea in adult patients with Short Bowel Syndrome (SBS)
    Disease: Version SOC Term Classification Code Term Level
    20.1 10017947 - Gastrointestinal disorders 10049416 Short-bowel syndrome PT
    20.1 10017947 - Gastrointestinal disorders 10080049 Bile acid diarrhea LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: PL (Completed)
    Trial results: View results
    EudraCT Number: 2019-002548-26 Sponsor Protocol Number: 0139 Start Date*: 2020-12-16
    Sponsor Name:Royal College of Surgeons in Irlenad
    Full Title: Can Pentoxifylline improve long-term outcomes in preterm infants with late-onset sepsis or necrotizing enterocolitis? A pragmatic, randomised, placebo controlled trial
    Medical condition: Late onset sepsis & necrotising enterocolitis
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004862 10053598 Late onset neonatal sepsis LLT
    20.1 100000004856 10028884 Necrotising enterocolitis LLT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: IE (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2017-004496-31 Sponsor Protocol Number: CNTO148UCO3003 Start Date*: 2018-11-07
    Sponsor Name:Janssen Biologics BV
    Full Title: A Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety,and Pharmacokinetics of Golimumab Treatment, a Human anti-TNFα Monoclonal Antibody, Administered Subcutaneously in Pediatric Pa...
    Medical condition: Ulcerative Colitis
    Disease: Version SOC Term Classification Code Term Level
    20.1 10017947 - Gastrointestinal disorders 10045365 Ulcerative colitis LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: BE (Ongoing) ES (Ongoing) FR (Ongoing) NL (Ongoing) PL (Ongoing) IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2011-002962-19 Sponsor Protocol Number: SKA 001 Start Date*: 2011-10-04
    Sponsor Name:University College Dublin
    Full Title: CHLORHEXIDINE VERSUS POVIDONE-IODINE FOR SKIN ANITSEPSIS PRIOR TO CENTRAL VENOUS CATHETER INSERTION IN PRETERM INFANTS: PROTOCOL FOR A RANDOMISED TRIAL (THE SKA TRIAL)
    Medical condition: Blood stream infections in neonates
    Disease:
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: IE (Completed)
    Trial results: View results
    EudraCT Number: 2006-006175-20 Sponsor Protocol Number: ACCORD 15/0608 - PRODIGE 7 Start Date*: 2009-05-11
    Sponsor Name:FNCLCC
    Full Title: Essai de phase III évaluant la place de la ChimioHyperthermie IntraPéritonéale per opératoire (CHIP) après résection maximale d'une carcinose péritonéale d'origine colorectale associée à une chimi...
    Medical condition: Notre étude multicentrique de phase III a donc pour objet de définir véritablement la place de la chimiohyperthermie intra-péritonéale en la randomisant chez ces patients ayant pu bénéficier d’une ...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10052171 Peritoneal carcinoma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Ongoing) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2021-003717-18 Sponsor Protocol Number: 215226/VIR-7831-5005 Start Date*: 2021-12-30
    Sponsor Name:GlaxoSmithKline Research & Development Limited
    Full Title: An open-label, non-comparator, multicenter study to describe the pharmacokinetics (PK), pharmacodynamics (PD; viral load) and safety following a single intravenous or intramuscular dose of sotrovim...
    Medical condition: COVID-19 at high risk of disease progression
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10021881 Infections and infestations SOC
    23.0 10021881 - Infections and infestations 10084268 COVID-19 PT
    23.1 10021881 - Infections and infestations 10084401 COVID-19 respiratory infection LLT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GR (Completed)
    Trial results: View results
    EudraCT Number: 2012-005748-12 Sponsor Protocol Number: 2012.761 Start Date*: 2013-04-26
    Sponsor Name:Hospices Civils de Lyon
    Full Title: D2 Resection and HIPEC (Hyperthermic intraperitoneal chemoperfusion) in locally advanced gastric carcinoma. A national randomized and multicentric phase III study
    Medical condition: Gastric adenocarcinoma
    Disease: Version SOC Term Classification Code Term Level
    19.1 100000004864 10017770 Gastric carcinoma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Ongoing) ES (Ongoing)
    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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