Phase 4
N=74
The HOME Study (HPN With OMEGA-3)
Patients Requiring Home Parenteral Nutrition
Bottom Line
View on ClinicalTrials.gov: NCT03282955 ↗Enrolled (actual)
74
Serious AEs
10.8%
Results posted
Jul 2025
Primary outcome: Primary: Change of Liver Function Parameters From Baseline to Visit 2 — 0.0606; -0.0703 normalized sum- no unit — p=0.025
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Lipidem (Drug); Lipofundin MCT 20% (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- B. Braun Melsungen AG
- Primary completion
- Jul 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change of Liver Function Parameters From Baseline to Visit 2 |
0.0606; -0.0703 | 0.025 sig |
| SECONDARY Bilirubin |
0.36; 0.04 | — |
| SECONDARY Alanine Transaminase (ALT) |
0.06; 0.01 | — |
| SECONDARY Aspartate Transaminase (AST) |
-0.03; -0.00 | — |
| SECONDARY AST/ALT Ratio |
0.53; 0.89 | — |
| SECONDARY Alkaline Phosphatase (ALP) |
0.13; -0.15 | — |
| SECONDARY Gamma-glutamyl Transpeptidase (GGT) |
0.02; -0.11 | — |
| SECONDARY White Blood Cells (WBCs) |
0.45; 0.19 | — |
| SECONDARY Red Blood Cells (RBCs) |
-0.02; -0.10 | — |
| SECONDARY Hemoglobin (Hb) |
0.52; -1.75 | — |
| SECONDARY Platelets |
3.06; 6.90 | — |
| SECONDARY International Normalized Ratio (INR) (if Not Possible Prothrombin Time [PT = Quick-value] is Accepted) |
-0.01; -0.16 | — |
| SECONDARY Activated Partial Thromboplastin Time (aPTT) |
0.02; 0.97 | — |
| SECONDARY Hematocrit (Hct) |
-0.00; -0.01 | — |
| SECONDARY Blood Glucose |
0.43; -0.14 | — |
| SECONDARY Sodium |
0.18; -0.58 | — |
| SECONDARY Chloride |
-0.19; -0.15 | — |
| SECONDARY Potassium |
0.06; 0.01 | — |
| SECONDARY Calcium |
-0.01; -0.01 | — |
| SECONDARY Magnesium |
0.00; -0.00 | — |
| SECONDARY Phosphate |
-0.02; -0.00 | — |
| SECONDARY Serum Creatinine |
3.87; 0.43 | — |
| SECONDARY Triglycerides |
0.10; 0.19 | — |
| SECONDARY Cholesterol |
0.01; 0.02 | — |
| SECONDARY High-density Lipoprotein (HDL) |
-0.12; 0.03 | — |
| SECONDARY Low-density Lipoprotein (LDL) |
0.07; -0.08 | — |
| SECONDARY C-reactive Protein (CRP) |
37.16; -24.65 | — |
| SECONDARY α-Tocopherol/Vitamin E (Facultative if Routinely Assessed) |
-3.00; -1.94 | — |
| SECONDARY Triene:Tetraene Ratio in Plasma, Reduction From Baseline |
0.011; 0.008 | — |
| SECONDARY Adverse Events |
31; 25 | — |
| SECONDARY BMI |
0.4; 0.2 | — |
| SECONDARY Prothrombin Time (PT) |
-0.8; 1.27 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03282955). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.