The HOME Study (HPN With OMEGA-3)

Study Overview
=================
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.

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

Conditions
-----------------
Patients Requiring Home Parenteral Nutrition

Intervention / Treatment
-----------------
* Drug: Lipidem
* Drug: Lipofundin MCT 20%


Participation Criteria
=================
Eligibility 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 3 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lipidem<br>i.v. lipid emulsion containing fractionated fish oil (n-3 fatty acid triglycerides) | Drug: Lipidem<br>* Lipoplus i.v. lipid emulsion for parenteral nutrition<br>|
| Active Comparator: Lipofundin MCT<br>i.v. lipid emulsion | Drug: Lipofundin MCT 20%<br>* Lipofundin MCT 20% i.v. lipid emulsion for parenteral nutrition<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of liver function parameters from baseline to visit 2 | Changes will be expressed as the sum of the N(0.1)-transformed differences of bilirubin, ALT and AST (visit 2 - baseline). | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bilirubin |  | 8 weeks | 
| Alanine transaminase (ALT) |  | 8 weeks | 
| Aspartate transaminase (AST) |  | 8 weeks | 
| AST/ALT ratio |  | 8 weeks | 
| Alkaline phosphatase (ALP) |  | 8 weeks | 
| Gamma-glutamyl transpeptidase (GGT) |  | 8 weeks | 
| White blood cells (WBCs) |  | 8 weeks | 
| Red blood cells (RBCs) |  | 8 weeks | 
| Hemoglobin (Hb) |  | 8 weeks | 
| Platelets |  | 8 weeks | 
| International normalized ratio (INR) (if not possible prothrombin time [PT = Quick-value] is accepted) |  | 8 weeks | 
| Activated partial thromboplastin time (aPTT) |  | 8 weeks | 
| Hematocrit (Hct) |  | 8 weeks | 
| Blood glucose |  | 8 weeks | 
| Sodium |  | 8 weeks | 
| Cloride |  | 8 weeks | 
| Potassium |  | 8 weeks | 
| Calcium |  | 8 weeks | 
| Magnesium |  | 8 weeks | 
| Phosphate |  | 8 weeks | 
| Serum creatinine |  | 8 weeks | 
| Triglycerides |  | 8 weeks | 
| Cholesterol |  | 8 weeks | 
| High-density lipoprotein (HDL) |  | 8 weeks | 
| Low-density lipoprotein (LDL) |  | 8 weeks | 
| C-reactive protein (CRP) |  | 8 weeks | 
| α-Tocopherol/Vitamin E (facultative if routinely assessed) |  | 8 weeks | 
| Fatty acid pattern in plasma and RBCs | Fatty acid pattern in plasma and RBCs, triene:tetraene ratio obtained from fatty acid pattern in plasma | 8 weeks | 
| Adverse events |  | 8 weeks | 
| BMI | Body mass index | 8 weeks |