Clinical Trials Register

Summary
EudraCT Number:	2015-000849-23
Sponsor's Protocol Code Number:	HC-G-H-1403
National Competent Authority:	UK - MHRA
Clinical Trial Type:	EEA CTA
Trial Status:	GB - no longer in EU/EEA
Date on which this record was first entered in the EudraCT database:	2018-02-23
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

UK - MHRA

A.2

EudraCT number

2015-000849-23

A.3

Full title of the trial

A RANDOMIZED, CONTROLLED, DOUBLE-BLIND, MULTICENTER CLINICAL TRIAL ON HOME PARENTERAL NUTRITION USING AN OMEGA-3 FATTY ACID ENRICHED MCT/LCT LIPID EMULSION

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

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

A.3.2

Name or abbreviated title of the trial where available

The HOME Study (HPN WITH OMEGA-3)

A.4.1

Sponsor's protocol code number

HC-G-H-1403

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	B. Braun Melsungen AG
B.1.3.4	Country	Germany
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	B. Braun Melsungen AG
B.4.2	Country	Germany
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	AMS Advanced Medical Services GmbH
B.5.2	Functional name of contact point	Clinical Operations
B.5.3	Address:
B.5.3.1	Street Address	Am Exerzierplatz 2
B.5.3.2	Town/ city	Mannheim
B.5.3.3	Post code	68167
B.5.3.4	Country	Germany
B.5.4	Telephone number	+4962170095100
B.5.5	Fax number	+4962170095140
B.5.6	E-mail	operations@ams-europe.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Lipidem, 200 mg/ml, emulsion for infusion
D.2.1.1.2	Name of the Marketing Authorisation holder	B. Braun Melsungen AG
D.2.1.2	Country which granted the Marketing Authorisation	Poland
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Emulsion for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Omega-3-acid triglycerides
D.3.9.3	Other descriptive name	OMEGA-3-ACID TRIGLYCERIDES
D.3.9.4	EV Substance Code	SUB12189MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g/l gram(s)/litre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	20
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	MEDIUM-CHAIN TRIGLYCERIDES BP
D.3.9.3	Other descriptive name	MEDIUM-CHAIN TRIGLYCERIDES BP
D.3.9.4	EV Substance Code	SUB179016
D.3.10	Strength
D.3.10.1	Concentration unit	g/l gram(s)/litre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	SOYA-BEAN OIL REFINED
D.3.9.3	Other descriptive name	SOYA-BEAN OIL REFINED
D.3.9.4	EV Substance Code	SUB12326MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g/l gram(s)/litre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	80
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Lipofundin MCT/LCT 20% (100 mg/ml + 100 mg/ml) emulsion for infusion
D.2.1.1.2	Name of the Marketing Authorisation holder	B. Braun Melsungen AG
D.2.1.2	Country which granted the Marketing Authorisation	Poland
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Emulsion for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	MEDIUM-CHAIN TRIGLYCERIDES BP
D.3.9.3	Other descriptive name	MEDIUM-CHAIN TRIGLYCERIDES BP
D.3.9.4	EV Substance Code	SUB179016
D.3.10	Strength
D.3.10.1	Concentration unit	g/l gram(s)/litre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	SOYA-BEAN OIL REFINED
D.3.9.3	Other descriptive name	SOYA-BEAN OIL REFINED
D.3.9.4	EV Substance Code	SUB12326MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g/l gram(s)/litre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Chronic intestinal failure

E.1.1.1

Medical condition in easily understood language

Reduction of the gut function below the minimum absorption capability that is required to maintain health and/or growth

E.1.1.2

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	SOC
E.1.2	Classification code	10017947
E.1.2	Term	Gastrointestinal disorders
E.1.2	System Organ Class	10017947 - Gastrointestinal disorders

E.1.3

Condition being studied is a rare disease

Yes

E.2 Objective of the trial

E.2.1

Main objective of the trial

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.

E.2.2

Secondary objectives of the trial

Secondary objective is the further evaluation of safety and efficacy of the lipid emulsion.

Secondary variables include parameters such as hepatic function, blood count and coagulation, blood biochemistry (e.g. blood glucose, electrolytes, triglycerides), BMI, BW change, fatty acid pattern in plasma and RBCs and adverse events. Furthermore, vital signs, quality of life, concomitant medication, PN prescription and treatment compliance will be assessed. Demographic data, anamnesis and physical examination will be examined as baseline variables.

E.2.3

Trial contains a sub-study

E.3

Principal 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

E.4

Principal 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.

E.5 End points

E.5.1

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.

E.5.1.1

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.

E.5.2

Secondary end point(s)

Secondary objective is the further evaluation of safety and efficacy of the lipid emulsion.

Safety variables
* Hepatic function
- Bilirubin (total and conjugated)
- 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)
- α-Tocopherol/Vitamin E (facultative if routinely assessed)
- Triene:tetraene ratio obtained from fatty acid pattern in
plasma

*Adverse events (AEs)

Efficacy variables
- Fatty acid pattern in plasma and RBCs [% of FA] (only at baseline and at visit 2)
- BMI [kg/m2]

Other variables
* 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

E.5.2.1

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).

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

Tolerability.

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

Yes

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

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:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

160

F.4.2.2

In the whole clinical trial

160

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

After the final visit no IP must be administered. The treatment will continue according to the decision of the physician with a regularly used lipid emulsion.

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2018-03-21

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-06-04

P. End of Trial
P.	End of Trial Status	GB - no longer in EU/EEA

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials