Chronic intestinal failure MedDRA version: 20.0 Level: SOC Classification code 10017947 Term: Gastrointestinal disorders System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Interventions
Trade Name: Lipidem, 200 mg/ml, emulsion for infusion
Pharmaceutical Form: Emulsion for infusion
INN or Proposed INN: Omega-3-acid triglycerides
Other descriptive name: OMEGA-3-ACID TRIGLYCERIDES
Conc
Sponsors
B. Braun Melsungen AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed informed consent available 2. Male or female patients = 18 years of age 3. 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 3 months 4. Patients receiving = 3.0 g lipids/kg body weight per week Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 130 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: 1. Persistent high total bilirubin values in medical history of the last 6 months (> 40µmol/l) 2. Patients in whom PN was interrupted for longer than 4 continuous weeks in the preceding 6 months 3. Patients with history of cancer and anti-cancer treatment within the last 2 years 4. Hypersensitivity to egg, fish, peanut or soya-bean protein or to any of the active substances or excipients 5. Patients treated in the past or currently with Teduglutide 6. 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 7. 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 8. Positive test for HIV, Hepatitis B or C (from medical history) 9. Known or suspected drug or alcohol abuse 10. Patients who are unwilling or mentally and/or physically unable to adhere to study procedures 11. Participation in another interventional clinical trial in parallel or within three months prior to the start of this clinical trial 12. 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) 13. Women of childbearing potential tested positive on standard pregnancy test (urine dipstick) 14. Lactation 15. Women of childbearing potential who do not agree to apply adequate contraception 16. Persons of legal age who are the subject of a legal protection measure or who are unable to express their consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study 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.;Secondary Objective: Secondary objective is the further evaluation of safety and efficacy of the lipid emulsion. ;Primary end point(s): The primary endpoint of the study is the change of liver function parameters defined as the sum of the N(0,1)-transformed differences in bilirubin, Alanine transaminase (ALT) and Aspartate transaminase (AST) from baseline to visit 2.;Timepoint(s) of evaluation of this end point: Timepoint is visit 2 which is normally conducted after 8 weeks - allowed tolerance range from this is -3 days up to + 2 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Timepoints are visit 1 which is normally conducted 4 weeks after start of IP infusion (allowed tolerance - 3 days up to + 2 weeks) and visit 2 which is normally conducted 4 weeks after visit 1 (allowed tolerance - 3 days up to + 2 weeks).;Secondary end point(s): Secondary objective is the further evaluation of safety and efficacy and other parameters of the lipid emulsion. Safety * Hepatic function - Bilirubin - Alanine transaminase (ALT) - Aspartate transaminase (AST) - AST/ALT ratio* - Alkaline phosphatase (ALP) - Gamma-glutamyl transpeptidase (GGT) * Blood count and coagulation - White blood cells (WBCs) - Red blood cells (RBCs) - Hemoglobin (Hb) - Hematocrit (Hct) - Platelets - International normalized ratio (INR) (if not possible prothrombin time [PT = Quick-value] is accepted) - Activated partial thromboplastin time (aPTT) * Other biochemical parameters - Blood glucose - Electrolytes (Na, Cl, K, Ca, Mg, P) - Serum creatinin - Triglycerides - Cholesterol - High-density lipoprotein (HDL) - Low-density lipoprotein (LDL) - C-reactive protein (CRP) - a-Tocopherol/Vitamin E (facultative if routinely assessed) - Triene:tetraene ratio* obtained from fatty acid pattern in plasma *Adverse events (AEs) Efficacy - Fatty acid pattern in plasma and RBCs [% of FA] (only at baseline and at visit 2) - BMI [kg/m2]* Other variables * Demographic data - Age - Gender - Ethnic origin - Body height - Body weight * Anamnesis - Medical history relevant with regard to HPN - Pathological classification of IF - Underlying disease - Concomitant disease(s) - Ongoing medications - Lipid emulsion(s) during the last 6 months - Anamnestic peculiarities * Physical examination * Vital signs * Body weight change* * Quality of life (EQ-5DTM) * Concomitant medication * Energy requirements * PN regimen prescription * Treatment compliance* * Intake of oily fish meals * Study termination | — |
Countries
Netherlands, United Kingdom
Contacts
Public ContactClinical Operations
AMS Advanced Medical Services GmbH
Outcome results
None listed