Clinical Trials Register

Summary
EudraCT Number:	2005-001938-32
Sponsor's Protocol Code Number:	HC-G-H-0503
National Competent Authority:	Germany - BfArM
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2007-04-23
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

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A. Protocol Information

A.1

Member State Concerned

Germany - BfArM

A.2

EudraCT number

2005-001938-32

A.3

Full title of the trial

EFFICACY, SAFETY, AND QUALITY OF LIFE OF A LONG-TERM HOME PARENTERAL NUTRITION REGIMEN WITH EITHER LIPIDEM® OR LIPOFUNDIN® MCT
A MONO-CENTER, RANDOMIZED, DOUBLE BLIND STUDY

A.3.1

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

Comparison in terms of efficacy, safety and quality of life of a long-term home parenteral nutrition supplemented with a lipid emulsion containing fish oil in comparison to a lipid emulsion without fish oil

A.3.2

Name or abbreviated title of the trial where available

Lipidem longterm application trial

A.4.1

Sponsor's protocol code number

HC-G-H-0503

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	B. Braun Melsungen AG
B.5.2	Functional name of contact point	Clinical Development
B.5.3	Address:
B.5.3.1	Street Address	Carl-Braun-Str. 1
B.5.3.2	Town/ city	Melsungen
B.5.3.3	Post code	34212
B.5.3.4	Country	Germany
B.5.4	Telephone number	00495661712706
B.5.5	Fax number	00495661752706
B.5.6	E-mail	ute.brauer@bbraun.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 20%
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	Germany
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.3.9.3	Other descriptive name	soy bean oil
D.3.10	Strength
D.3.10.1	Concentration unit	% percent
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	8
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.3	Other descriptive name	medium chain triglycerides
D.3.10	Strength
D.3.10.1	Concentration unit	% percent
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.3	Other descriptive name	omega 3 acid triglycerides
D.3.10	Strength
D.3.10.1	Concentration unit	% percent
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	2
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	Yes
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	Yes
D.3.11.13.1	Other medicinal product type	emulsion for parenteral nutrition
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 20%
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	Germany
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.3.9.3	Other descriptive name	soy bean oil
D.3.10	Strength
D.3.10.1	Concentration unit	% percent
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.3	Other descriptive name	medium chain triglycerides
D.3.10	Strength
D.3.10.1	Concentration unit	% percent
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
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	Yes
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	Yes
D.3.11.13.1	Other medicinal product type	emulsion for parenteral nutrition

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

The trial aims at providing patients with insufficient absorption capacity, that may not be compensated by enteral nutrition, with the required amount of caloric supply.
The insufficient absorption capacity may a multiple reasons.
The majority of patients will be oncologic patients.

E.1.1.1

Medical condition in easily understood language

Supply of lipids as part of a parenteral nutrition regimen, when oral or enteral nutrition is impossible, insufficient or contra-indicated.

E.1.1.2

Therapeutic area

Diseases [C] - Nutritional and Metabolic Diseases [C18]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	PT
E.1.2	Classification code	10051284
E.1.2	Term	Parenteral nutrition
E.1.2	System Organ Class	10042613 - Surgical and medical procedures

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Proof of noninferiority of a HPN regimen containing Lipidem compared to a Lipofundin MCT containing regimen as indicated by the BMI.

E.2.2

Secondary objectives of the trial

Evaluation of beneficial effects of a long-term HPN-regimen with Lipidem on Quality of Life and body composition.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Patients with a need of long-term home parenteral nutrition (HPN) for at least 8 weeks
- Age >18 years and <80 years
- Male and female patients
- Signed Informed consent
- Mentally and physically able to adhere to study procedures
- Females agree to apply adequate contraception
- Patients with an insufficient absorption capacity that may not be compensated by enteral nutrition

E.4

Principal exclusion criteria

- Participation in a clinical study with an investigational drug within one month prior to the start of study
- Patients with sepsis, severe sepsis and septic shock
- Known or suspected drug abuse
- General contraindications for infusion therapy such as acute pulmonary oedema, hyper hydration and decompensated cardiac insufficiency
- Pregnancy (positive in urine) and lactation
- Autoimmune disease e.g. HIV
- Known hypersensitivity to egg-, soy-, and fish proteins or any of the ingredients
- Haemodynamical failure of any origin (haemorrhagic shock, myocardial infarction, cardiac failure)
- Alterations of coagulation (thrombocytes <120000 mm3), PT <50%, PTT >40 sec
- Ketoacidosis caused by Diabetes mellitus within 7 days prior to onset of study
- Renal insufficiency with serum creatinine >1.4 mg/dL (>124 µmol/L). In a range from 1.4 mg/dL (124 µmol/L) to 2.4 mg/dL (212 µmol/L) it is a decision of the physician depending on the kind of disease, the physical constitution and the indivudual need of the patient.
- Patients with severe liver dysfunction with bilirubin >2.5 mg/dL (>43 µmol/L)
- Lipid disorders, in particular fasting serum triglycerides > 250 mg/dL (>2.86 mmol/L). In a range from 250 mg/dL (2.86 mmol/L) to 300 mg/dL (3.43 mmol/L) it is a decision of the physician depending on the kind of disease, the physical constitution and the individual need of the patient.
- Necrotizing pancreatitis

E.5 End points

E.5.1

Primary end point(s)

It is anticipated that the nutritional status of patients being provided with a HPN regimen containing n-3 PUFA is non inferior to that of patients being provided with a HPN regimen without n-3 PUFA. It is expected that patients receiving n-3 PUFA will show a similar evolution of their BMI compared to patients receiving the standard lipid emulsion without n-3 PUFA.

E.5.1.1

Timepoint(s) of evaluation of this end point

Baseline, after 4 weeks, after 8 weeks

E.5.2

Secondary end point(s)

Efficacy: IL-6, IL-10, CRP, TNFα , Body Cell Mass (BCM), Indirect Calorimetry,
Safety & Further: ALT, AST, gGT, AP, PT, aPTT, ostase
Adverse Events, Vitamin E, Transferrin, Albumin, Triglyceride, Cholesterol, Creatinine, Urea, Bilirubin, Lactate, Hemoglobin, Hematocrit, Glucose, Leukocytes, Platelets, Erythrocytes, pH, Na+, K+, Ca++, Mg++, Cl-, anamnesis, anamnestic peculiarities, physical examination, vital signs
Quality of life: EORTC QLQ-C30

E.5.2.1

Timepoint(s) of evaluation of this end point

Baseline, after 4 weeks, after 8 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

Noninferiority

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

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

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.5

The trial involves multiple Member States

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

Information not present in EudraCT

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

last visit, last patient

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:

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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2007-04-23.

Yes

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.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)

patients will be provided with the standard nutritional treatment provided at the trial center

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

2007-05-29

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2007-05-08

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2014-01-15

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