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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lipidem | Experimental | i.v. lipid emulsion containing fractionated fish oil (n-3 fatty acid triglycerides) |
|
| Lipofundin MCT | Active Comparator | i.v. lipid emulsion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lipidem | Drug | Lipoplus i.v. lipid emulsion for parenteral nutrition |
| |
| 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 (from Baseline to Visit 2), i.e. for all three parameters each change of the value is subtracted by the mean change of the respective parameter. This difference is divided by the standard deviation of the change, which results in a unitless normalised value. All values for the 3 liver parameters (bilirubin, ALT and AST) will be added. The final sum reflects the change of liver function parameters. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Bilirubin | Change from baseline | 8 weeks |
| Alanine Transaminase (ALT) | Change from baseline | 8 weeks |
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Inclusion:
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:
General contraindications to parenteral nutrition (if available from medical records) including:
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Archet 2 - Unité de support nutritionnel | Nice | France | ||||
| Hospices Civiles de Lyon - Centre hospitalier Lyon Sud |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39581180 | Derived | Klek S, Chambrier C, Szczepanek K, Kunecki M, Sobocki J, Wanten G, Pironi L, Schneider SM, Rahman F, Cooper SC, Calder PC, Gabe S, Forbes A. Safe and well-tolerated long-term parenteral nutrition regimen: Omega-3-fatty-acid-enriched medium chained/ long chained triglycerides emulsion. Clin Nutr. 2024 Dec;43(12):415-424. doi: 10.1016/j.clnu.2024.11.007. Epub 2024 Nov 7. | |
| 31888740 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lipidem | i.v. lipid emulsion containing fractionated fish oil (n-3 fatty acid triglycerides) Lipidem: Lipoplus i.v. lipid emulsion for parenteral nutrition |
| FG001 | Lipofundin MCT | i.v. lipid emulsion Lipofundin MCT 20%: Lipofundin MCT 20% i.v. lipid emulsion for parenteral nutrition |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
74 patients were enrolled for the study. However, 2 patients dropped out before any further intervention. Therefor these 2 patients were not included in the baseline analysis population.
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| ID | Title | Description |
|---|---|---|
| BG000 | Lipidem | i.v. lipid emulsion containing fractionated fish oil (n-3 fatty acid triglycerides) Lipidem: Lipoplus i.v. lipid emulsion for parenteral nutrition |
| BG001 | Lipofundin MCT |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 (from Baseline to Visit 2), i.e. for all three parameters each change of the value is subtracted by the mean change of the respective parameter. This difference is divided by the standard deviation of the change, which results in a unitless normalised value. All values for the 3 liver parameters (bilirubin, ALT and AST) will be added. The final sum reflects the change of liver function parameters. | Full Analysis Set | Posted | Mean | Standard Deviation | normalized sum- no unit | 8 weeks |
|
8 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lipidem | i.v. lipid emulsion containing fractionated fish oil (n-3 fatty acid triglycerides) Lipidem: Lipoplus i.v. lipid emulsion for parenteral nutrition |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stoma site infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| White blood cell | Investigations | MedDRA (20.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Manager | B. Braun Melsungen | 05661/71 | 0 | studies@bbraun.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 21, 2021 | Feb 5, 2025 | Prot_SAP_000.pdf |
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| Lipofundin MCT 20% |
| Drug |
Lipofundin MCT 20% i.v. lipid emulsion for parenteral nutrition |
|
| Aspartate Transaminase (AST) | Change from baseline | 8 weeks |
| AST/ALT Ratio | Change from baseline | 8 weeks |
| Alkaline Phosphatase (ALP) | Change from baseline | 8 weeks |
| Gamma-glutamyl Transpeptidase (GGT) | Change from baseline | 8 weeks |
| White Blood Cells (WBCs) | Change from baseline | 8 weeks |
| Red Blood Cells (RBCs) | Change from baseline | 8 weeks |
| Hemoglobin (Hb) | Change from baseline | 8 weeks |
| Platelets | Change from baseline | 8 weeks |
| International Normalized Ratio (INR) (if Not Possible Prothrombin Time [PT = Quick-value] is Accepted) | Change from baseline | 8 weeks |
| Activated Partial Thromboplastin Time (aPTT) | Change from baseline | 8 weeks |
| Hematocrit (Hct) | Change from baseline | 8 weeks |
| Blood Glucose | Change from baseline | 8 weeks |
| Sodium | Change from baseline | 8 weeks |
| Chloride | Change from baseline | 8 weeks |
| Potassium | Change from baseline | 8 weeks |
| Calcium | Change from baseline | 8 weeks |
| Magnesium | Change from baseline | 8 weeks |
| Phosphate | Change from baseline | 8 weeks |
| Serum Creatinine | Change from baseline | 8 weeks |
| Triglycerides | Change from baseline | 8 weeks |
| Cholesterol | Change from baseline | 8 weeks |
| High-density Lipoprotein (HDL) | Change from baseline | 8 weeks |
| Low-density Lipoprotein (LDL) | Change from baseline | 8 weeks |
| C-reactive Protein (CRP) | Change from baseline | 8 weeks |
| α-Tocopherol/Vitamin E (Facultative if Routinely Assessed) | Change from baseline | 8 weeks |
| Triene:Tetraene Ratio in Plasma, Reduction From Baseline | Derived from fatty acid pattern in plasma | 8 weeks |
| Adverse Events | Number of adverse events (including serious adverse events) | 8 weeks |
| BMI | Body mass index Change from baseline | 8 weeks |
| Prothrombin Time (PT) | Change from baseline | 8 weeks |
| Pierre-Bénite |
| France |
| Department of Medical and Surgical Science, University of Bologna, Center for Chronic Intestinal Failure, Department of Digestive System, St. Orsola-Malpighi Hospital | Bologna | Italy |
| Radboud university medical center | Nijmegen | Netherlands |
| Wojewódzkim Specjalistycznym Szpitalem im. M. Pirogowa w Łodzi , Oddział Chirurgii Ogólnej i Naczyniowej | Lodz | Poland |
| Stanley Dudrick's Memorial Hospital | Skawina | Poland |
| Samodzielny Publiczny Szpital Kliniczny, im. prof. dr W. Orlowskiego, Centrum Medycznego Ksztalcenia Podyplomowego, Oddzial Kliniczny Zywienia i Chirurgii | Warsaw | Poland |
| University Hospitals Birmingham NHS Foundation Trust | Birmingham | United Kingdom |
| University College Hospital London | London | United Kingdom |
| Derived |
| Klek S, Chambrier C, Cooper SC, Gabe S, Kunecki M, Pironi L, Rahman F, Sobocki J, Szczepanek K, Wanten G, Lincke N, Glotzbach B, Forbes A. Home parenteral nutrition with an omega-3-fatty-acid-enriched MCT/LCT lipid emulsion in patients with chronic intestinal failure (the HOME study): study protocol for a randomized, controlled, multicenter, international clinical trial. Trials. 2019 Dec 30;20(1):808. doi: 10.1186/s13063-019-3994-z. |
i.v. lipid emulsion
Lipofundin MCT 20%: Lipofundin MCT 20% i.v. lipid emulsion for parenteral nutrition
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| Lipofundin MCT |
i.v. lipid emulsion Lipofundin MCT 20%: Lipofundin MCT 20% i.v. lipid emulsion for parenteral nutrition |
|
|
|
| Secondary | Bilirubin | Change from baseline | Posted | Mean | Standard Deviation | µmol/L | 8 weeks |
|
|
|
| Secondary | Alanine Transaminase (ALT) | Change from baseline | Posted | Mean | Standard Deviation | µkat/L | 8 weeks |
|
|
|
| Secondary | Aspartate Transaminase (AST) | Change from baseline | Posted | Mean | Standard Deviation | µkat/L | 8 weeks |
|
|
|
| Secondary | AST/ALT Ratio | Change from baseline | Posted | Mean | Standard Deviation | Ratio | 8 weeks |
|
|
|
| Secondary | Alkaline Phosphatase (ALP) | Change from baseline | Posted | Mean | Standard Deviation | µkat/L | 8 weeks |
|
|
|
| Secondary | Gamma-glutamyl Transpeptidase (GGT) | Change from baseline | Safety Set | Posted | Mean | Standard Deviation | µkat/L | 8 weeks |
|
|
|
| Secondary | White Blood Cells (WBCs) | Change from baseline | Posted | Mean | Standard Deviation | 10^9 cells/L | 8 weeks |
|
|
|
| Secondary | Red Blood Cells (RBCs) | Change from baseline | Posted | Mean | Standard Deviation | 10^12 cells/L | 8 weeks |
|
|
|
| Secondary | Hemoglobin (Hb) | Change from baseline | Posted | Mean | Standard Error | g/L | 8 weeks |
|
|
|
| Secondary | Platelets | Change from baseline | Posted | Mean | Standard Deviation | 10^9 cells/L | 8 weeks |
|
|
|
| Secondary | International Normalized Ratio (INR) (if Not Possible Prothrombin Time [PT = Quick-value] is Accepted) | Change from baseline | Posted | Mean | Standard Deviation | Ratio | 8 weeks |
|
|
|
| Secondary | Activated Partial Thromboplastin Time (aPTT) | Change from baseline | Posted | Mean | Standard Deviation | seconds | 8 weeks |
|
|
|
| Secondary | Hematocrit (Hct) | Change from baseline | Posted | Mean | Standard Deviation | L/L | 8 weeks |
|
|
|
| Secondary | Blood Glucose | Change from baseline | Posted | Mean | Standard Deviation | mmol/L | 8 weeks |
|
|
|
| Secondary | Sodium | Change from baseline | Posted | Mean | Standard Deviation | mmol/L | 8 weeks |
|
|
|
| Secondary | Chloride | Change from baseline | Posted | Mean | Standard Deviation | mmol/L | 8 weeks |
|
|
|
| Secondary | Potassium | Change from baseline | Posted | Mean | Standard Deviation | mmol/L | 8 weeks |
|
|
|
| Secondary | Calcium | Change from baseline | Posted | Mean | Standard Deviation | mmol/L | 8 weeks |
|
|
|
| Secondary | Magnesium | Change from baseline | Posted | Mean | Standard Deviation | mmol/L | 8 weeks |
|
|
|
| Secondary | Phosphate | Change from baseline | Posted | Mean | Standard Deviation | mmol/L | 8 weeks |
|
|
|
| Secondary | Serum Creatinine | Change from baseline | Posted | Mean | Standard Deviation | µmol/L | 8 weeks |
|
|
|
| Secondary | Triglycerides | Change from baseline | Posted | Mean | Standard Deviation | mmol/L | 8 weeks |
|
|
|
| Secondary | Cholesterol | Change from baseline | Posted | Mean | Standard Deviation | mmol/L | 8 weeks |
|
|
|
| Secondary | High-density Lipoprotein (HDL) | Change from baseline | Posted | Mean | Standard Deviation | mmol/L | 8 weeks |
|
|
|
| Secondary | Low-density Lipoprotein (LDL) | Change from baseline | Posted | Mean | Standard Deviation | mmol/L | 8 weeks |
|
|
|
| Secondary | C-reactive Protein (CRP) | Change from baseline | Posted | Mean | Standard Deviation | nmol/L | 8 weeks |
|
|
|
| Secondary | α-Tocopherol/Vitamin E (Facultative if Routinely Assessed) | Change from baseline | Posted | Mean | Standard Deviation | µmol/L] | 8 weeks |
|
|
|
| Secondary | Triene:Tetraene Ratio in Plasma, Reduction From Baseline | Derived from fatty acid pattern in plasma | Posted | Mean | Standard Deviation | Ratio | 8 weeks |
|
|
|
| Secondary | Adverse Events | Number of adverse events (including serious adverse events) | Posted | Number | Adverse events | 8 weeks |
|
|
|
| Secondary | BMI | Body mass index Change from baseline | Full Analysis Set | Posted | Mean | Standard Deviation | kg/m^2 | 8 weeks |
|
|
|
| Secondary | Prothrombin Time (PT) | Change from baseline | Posted | Mean | Standard Deviation | s | 8 weeks |
|
|
|
| 0 |
| 40 |
| 5 |
| 40 |
| 15 |
| 40 |
| EG001 | Lipofundin MCT | i.v. lipid emulsion Lipofundin MCT 20%: Lipofundin MCT 20% i.v. lipid emulsion for parenteral nutrition | 0 | 34 | 3 | 34 | 12 | 34 |
| Device related infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment |
|
| Device breakage | Product Issues | MedDRA (20.1) | Systematic Assessment |
|
| Dermo-hypodermitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
|
| Device dislocatioin | Product Issues | MedDRA (20.1) | Systematic Assessment |
|
| Intestinal pseudo-obstruction | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
|
| Overdose | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
|
| Alanine Aminotransferase increased | Investigations | MedDRA (20.1) | Systematic Assessment |
|
| Breast abscess | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
|
| Hyperhydrosis | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (20.1) | Systematic Assessment |
|
| Asparte Aminotransferase increased | Investigations | MedDRA (20.1) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
|
| Tracheitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
|
| Drug Hypersensitivity | Immune system disorders | MedDRA (20.1) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
|
| Lymphangitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
|
| Paresthesia | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (20.1) | Systematic Assessment |
|
| Dyspnoe exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
|
| Intestinal pseudo-obstruction | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
|
| Deep vein thrombosis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
|
| Device infusion issue | Product Issues | MedDRA (20.1) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
|
| Laryngitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
|
| Lung infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
|
In order to ensure that the Sponsor will be able to make comments and suggestions where pertinent, material for public dissemination will be submitted to the Sponsor for review at least sixty (60) days (or longer if specified elsewhere) prior to submission for publication, public dissemination, or review by a publication committee.
The PI agrees that all reasonable comments made by the Sponsor in relation to a proposed publication will be incorporated into the publication.