Clinical trial to investigate safety and efficacy of an Omega-3-fatty acid triglycerides (fish-oil”) enriched lipid emulsion in comparison to a lipid emulsion not containing fish-oil” in home parenteral nutrition in adults
- Conditions
- Chronic intestinal failureMedDRA version: 20.0Level: SOCClassification code 10017947Term: Gastrointestinal disordersSystem Organ Class: 10017947 - Gastrointestinal disordersTherapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2015-000849-23-NL
- Lead Sponsor
- B. Braun Melsungen AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 160
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.<br>;Primary end point(s): The primary endpoint of the study is the change of liver function<br>parameters defined as the sum of the N(0,1)-transformed differences in<br>bilirubin, Alanine transaminase (ALT) and Aspartate transaminase (AST)<br>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 Outcome Measures
Name Time Method