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Trial record 28 of 585 for:    bilirubin AND liver function

The HOME Study (HPN With OMEGA-3) (HOME)

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ClinicalTrials.gov Identifier: NCT03282955
Recruitment Status : Recruiting
First Posted : September 14, 2017
Last Update Posted : July 11, 2019
Sponsor:
Information provided by (Responsible Party):
B. Braun Melsungen AG

Brief Summary:
The aim of the trial is to investigate safety and tolerability of an Omega-3-FA-enriched lipid emulsion in adult patients with chronic intestinal failure in need of long-term HPN. It is aimed to show non-inferiority of the lipid emulsion Lipidem (investigational test product) in comparison to the lipid emulsion Lipofundin MCT (investigational reference product) with regard to liver function.

Condition or disease Intervention/treatment Phase
Patients Requiring Home Parenteral Nutrition Drug: Lipidem Drug: Lipofundin MCT 20% Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Controlled, Double-blind, Multicenter Clinical Trial on Home Parenteral Nutrition Using an Omega-3 Fatty Acid Enriched MCT/LCT Lipid Emulsion
Actual Study Start Date : January 8, 2018
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : December 31, 2021

Arm Intervention/treatment
Experimental: Lipidem
i.v. lipid emulsion containing fractionated fish oil (n-3 fatty acid triglycerides)
Drug: Lipidem
Lipoplus i.v. lipid emulsion for parenteral nutrition

Active Comparator: Lipofundin MCT
i.v. lipid emulsion
Drug: Lipofundin MCT 20%
Lipofundin MCT 20% i.v. lipid emulsion for parenteral nutrition




Primary Outcome Measures :
  1. Change of liver function parameters from baseline to visit 2 [ Time Frame: 8 weeks ]
    Changes will be expressed as the sum of the N(0.1)-transformed differences of bilirubin, ALT and AST (visit 2 - baseline).


Secondary Outcome Measures :
  1. Bilirubin [ Time Frame: 8 weeks ]
  2. Alanine transaminase (ALT) [ Time Frame: 8 weeks ]
  3. Aspartate transaminase (AST) [ Time Frame: 8 weeks ]
  4. AST/ALT ratio [ Time Frame: 8 weeks ]
  5. Alkaline phosphatase (ALP) [ Time Frame: 8 weeks ]
  6. Gamma-glutamyl transpeptidase (GGT) [ Time Frame: 8 weeks ]
  7. White blood cells (WBCs) [ Time Frame: 8 weeks ]
  8. Red blood cells (RBCs) [ Time Frame: 8 weeks ]
  9. Hemoglobin (Hb) [ Time Frame: 8 weeks ]
  10. Platelets [ Time Frame: 8 weeks ]
  11. International normalized ratio (INR) (if not possible prothrombin time [PT = Quick-value] is accepted) [ Time Frame: 8 weeks ]
  12. Activated partial thromboplastin time (aPTT) [ Time Frame: 8 weeks ]
  13. Hematocrit (Hct) [ Time Frame: 8 weeks ]
  14. Blood glucose [ Time Frame: 8 weeks ]
  15. Sodium [ Time Frame: 8 weeks ]
  16. Cloride [ Time Frame: 8 weeks ]
  17. Potassium [ Time Frame: 8 weeks ]
  18. Calcium [ Time Frame: 8 weeks ]
  19. Magnesium [ Time Frame: 8 weeks ]
  20. Phosphate [ Time Frame: 8 weeks ]
  21. Serum creatinine [ Time Frame: 8 weeks ]
  22. Triglycerides [ Time Frame: 8 weeks ]
  23. Cholesterol [ Time Frame: 8 weeks ]
  24. High-density lipoprotein (HDL) [ Time Frame: 8 weeks ]
  25. Low-density lipoprotein (LDL) [ Time Frame: 8 weeks ]
  26. C-reactive protein (CRP) [ Time Frame: 8 weeks ]
  27. α-Tocopherol/Vitamin E (facultative if routinely assessed) [ Time Frame: 8 weeks ]
  28. Fatty acid pattern in plasma and RBCs [ Time Frame: 8 weeks ]
    Fatty acid pattern in plasma and RBCs, triene:tetraene ratio obtained from fatty acid pattern in plasma

  29. Adverse events [ Time Frame: 8 weeks ]
  30. BMI [ Time Frame: 8 weeks ]
    Body mass index



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion:

  • Signed informed consent available
  • Male or female patients ≥ 18 years of age
  • Patients with chronic intestinal failure receiving HPN including lipids in whom the parenteral macronutrients have not been changed by more than 10% for at least 6 months
  • Patients receiving ≥ 3.0 g lipids/kg body weight per week

Exclusion:

  • Persistent high total bilirubin values in medical history of last 6 months (> 40µmol/l)
  • Patients in whom PN was interrupted for longer than 4 continuous weeks in the preceding 6 months
  • Patients with history of cancer and anti-cancer treatment within the last 2 years
  • Hypersensitivity to egg, fish, peanut or soya-bean protein or to any of the active substances or excipients
  • Patients treated in the past or currently with Teduglutide
  • Contraindications to investigational products (if available from medical records) including:

    • Severe hyperlipidemia, including severe hypertriglyceridaemia (≥1000 mg/dl or 11.4 mmol/l)
    • Severe coagulopathy
    • Intrahepatic cholestasis
    • Severe hepatic insufficiency
    • Severe renal insufficiency in absence of renal replacement therapy
    • Acute thromboembolic events
    • Fat embolism
    • Aggravating haemorrhagic diatheses
    • Metabolic acidosis
  • General contraindications to parenteral nutrition (if available from medical records) including:

    • Unstable circulatory status with vital threat (states of collapse and shock)
    • Acute phase of cardiac infarction or stroke
    • Unstable metabolic conditions (e.g. decompensated diabetes mellitus, severe sepsis, coma of unknown origin)
    • Inadequate cellular oxygen supply
    • Disturbances of the electrolyte and fluid balance (e.g. hypokalaemia and hypotonic dehydration)
    • Acute pulmonary edema
    • Decompensated cardiac insufficiency
  • Positive test for HIV, Hepatitis B or C (from medical history)
  • Known or suspected drug or alcohol abuse
  • Patients who are unwilling or mentally and/or physically unable to adhere to study procedures
  • Participation in another interventional clinical trial in parallel or within three months prior to the start of this clinical trial
  • Any medical condition that in the opinion of the investigator might put the subject at risk or interfere with patients participation For women with childbearing potential (i.e. females who are not chemically or surgically sterile or females who are not post-menopausal)
  • Women of childbearing potential tested positive on standard pregnancy test (urine dipstick)
  • Lactation
  • Women of childbearing potential who do not agree to apply adequate contraception
  • Persons of legal age who are the subject of a legal protection measure or who are unable to express their consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03282955


Contacts
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Contact: Study Manager +495661710 studies@bbraun.com

Locations
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France
Hospices Civiles de Lyon - Centre hospitalier Lyon Sud Recruiting
Pierre-Bénite, France
Contact: Cécile Chambrier, Dr.         
Italy
Department of Medical and Surgical Science, University of Bologna, Center for Chronic Intestinal Failure, Department of Digestive System, St. Orsola-Malpighi Hospital Recruiting
Bologna, Italy
Contact: Loris Pironi, Prof.         
Netherlands
Radboud university medical center Recruiting
Nijmegen, Netherlands
Contact: Geert Wanten, Dr.         
Poland
Stanley Dudrick`s Memorial Hospital Recruiting
Skawina, Poland
Contact: Stanislaw Klek, Prof.         
Principal Investigator: Stanislaw Klek, Prof.         
Samodzielny Publiczny Szpital Kliniczny, im. prof. dr W. Orlowskiego, Centrum Medycznego Ksztalcenia Podyplomowego, Oddzial Kliniczny Zywienia i Chirurgii Recruiting
Warszawa, Poland
Contact: Jacek Sobocki, Dr.         
Wojewódzkim Specjalistycznym Szpitalem im. M. Pirogowa w Łodzi , Oddział Chirurgii Ogólnej i Naczyniowej Recruiting
Łódź, Poland
Contact: Marek Kunecki, Dr.         
United Kingdom
University of East Anglia, Faculty of Medicine and Health Sciences Not yet recruiting
Norwich, United Kingdom
Contact: Alastair Forbes, Prof.         
Sponsors and Collaborators
B. Braun Melsungen AG

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Responsible Party: B. Braun Melsungen AG
ClinicalTrials.gov Identifier: NCT03282955     History of Changes
Other Study ID Numbers: HC-G-H-1403
First Posted: September 14, 2017    Key Record Dates
Last Update Posted: July 11, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No