Clinical Trials Register

Summary
EudraCT Number:	2010-021018-49
Sponsor's Protocol Code Number:	FOILED
National Competent Authority:	Germany - BfArM
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2012-01-18
Trial 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

2010-021018-49

A.3

Full title of the trial

Fish OIL optimal dosE Determination Study

Findungsstudie für die Optimaldosierung von Fischöl

A.3.1

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

This study is designed to establish the optimal dose of IV fish oils for treating patients with severe sepsis and septic shock. Primary outcomes will be change in organ function scores and blood tests.

Diese Studie dient der Bestimmung der Optimaldosierung von intravenösem Fischöl zur Unterstützung der Therapie bei schwerer Sepsis und septischem Schock. Primäre Studienendpunkte sind Änderungen der Organfunktions-Punktwerte im "SOFA- Score" sowie von Blutwerten.

A.3.2

Name or abbreviated title of the trial where available

FOILED

A.4.1

Sponsor's protocol code number

FOILED

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT01146821

A.5.4

Other Identifiers

Name:

IRB Med Faculty Dresden

Number:

EK371102011

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	GWT-TUD GmbH
B.1.3.4	Country	Germany
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Fresenius- Kabi
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	University Hospital Dresden
B.5.2	Functional name of contact point	UHD
B.5.3	Address:
B.5.3.1	Street Address	Fetscherstrasse 74
B.5.3.2	Town/ city	Dresden
B.5.3.3	Post code	D-01307
B.5.3.4	Country	Germany
B.5.4	Telephone number	+493514583703
B.5.5	Fax number	+49358449210405
B.5.6	E-mail	axel.heller@uniklinikum-dresden.de

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	Omegaven- Fresenius
D.2.1.1.2	Name of the Marketing Authorisation holder	Fresenius- Kabi Deutschland
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.3.1	Product name	Omegaven-Fresenius
D.3.2	Product code	Omegaven-Fresenius
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 drip use (Noncurrent)
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Icosapent
D.3.9.1	CAS number	10417-94-4
D.3.9.2	Current sponsor code	Icosapent
D.3.9.3	Other descriptive name	Icosapent
D.3.10	Strength
D.3.10.1	Concentration unit	g/l gram(s)/litre
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	12.5 to 28.2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Palmitic acid
D.3.9.1	CAS number	57-10-3
D.3.9.2	Current sponsor code	Palmitic acid
D.3.9.3	Other descriptive name	Palmitic acid
D.3.10	Strength
D.3.10.1	Concentration unit	g/l gram(s)/litre
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	2.5 to 10
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Oleic acid
D.3.9.1	CAS number	112-80-1
D.3.9.2	Current sponsor code	Oleic acid
D.3.9.3	Other descriptive name	Oleic acid
D.3.10	Strength
D.3.10.1	Concentration unit	g/l gram(s)/litre
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	6 to 13
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Linoleic acid
D.3.9.1	CAS number	60-33-3
D.3.9.2	Current sponsor code	Linoleic acid
D.3.9.3	Other descriptive name	Linoleic acid
D.3.10	Strength
D.3.10.1	Concentration unit	g/l gram(s)/litre
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	1 to 7
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Linolenic acid
D.3.9.1	CAS number	463-40-1
D.3.9.2	Current sponsor code	Linolenic acid
D.3.9.3	Other descriptive name	Linolenic acid
D.3.10	Strength
D.3.10.1	Concentration unit	g/l gram(s)/litre
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	0 to 2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Docosapentaenoic acid
D.3.9.1	CAS number	25448-00-4
D.3.9.2	Current sponsor code	Docosapentaenoic acid
D.3.9.3	Other descriptive name	Docosapentaenoic acid
D.3.10	Strength
D.3.10.1	Concentration unit	g/l gram(s)/litre
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	1.5 to 4.5
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

Mechanically ventilated adult patients (>18 years old) admitted to ICU with clinical evidence of sepsis, sepsis associated organ dysfunction, and high expression of inflammatory cytokines.

Erwachsene Patienten mit Sepsis

E.1.1.1

Medical condition in easily understood language

adult patients (>18 years old) admitted to intensive care wards with sepsis

Erwachsene Patienten auf Intensivstationen mit Sepsis

E.1.1.2

Therapeutic area

Diseases [C] - Bacterial Infections and Mycoses [C01]

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	10040070
E.1.2	Term	Septic shock
E.1.2	System Organ Class	10021881 - Infections and infestations

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	10040047
E.1.2	Term	Sepsis
E.1.2	System Organ Class	10021881 - Infections and infestations

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

to establish the safety of high doses of IV fish oils, primary outcomes will be change in SOFA score (organ function) and biochemical parameters of safety (i.e. blood lipid levels, coagulation parameters, bleeding episodes, standard biochemistry).

Überprüfung der Sicherheit höherer intravenöser Dosen von Fischöl. Primäre Studienendpunkte sind Änderungen des SOFA- Scores sowie biochemischer Sicherheitsparameter.

E.2.2

Secondary objectives of the trial

Markers of systemic inflammation [pro‐calcitonin [PCT], C‐reactive protein [CRP],
interleukin‐1 [IL‐6] and IL‐10) and markers of innate immunity [such as lipopolysaccharide [LPS] ex‐vivo stimulation of tumor necrosis factor‐alpha [TNF‐α]]. Clinical outcomes:
ICU and hospital length of stay, number of infections, length of ventilation, and ICU, 28‐day, and hospital mortality rate.

Marker der systemischen Inflammation sowie die klinischen Endpunkte Intensivaufenthalt, Krankenhausaufenthalt, Anzahl der Infektionen, Beatmungsdauer, Sterblichkeit

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1) Adult patients (>18 years old) admitted to ICU and expected to stay more than 72 hours
2) Requiring mechanical ventilation either invasive or non‐invasive
3) Clinical evidence of sepsis defined by Bone et al 1998:
4) Presence of 1 or more of the following organ failures related to their acute illness:
i. A PaO2/FiO2 ratio of <300;
ii. Clinical evidence of hypoperfusion defined as the need for vasopressor agents (norepinephrine, epinephrine, vasopressin, > 5 μg/kg/min of dopamine, or > 50 μg/min phenylephrine) for greater than or equal to 2 hours;
iii. In patients without known renal disease, renal dysfunction defined as a serum creatinine >171 μmol/L or a urine output of less than 500 ml/last 24 hours (or 80 ml/last 4 hours if a 24 hour period of observation not available). In patients with acute on chronic renal failure (pre‐dialysis), an absolute increase of >80 μmol/L from baseline or pre‐admission creatinine or a urine output of <500 ml/last 24 hours (or 80 ml/last 4 hours) will be required

E.4

Principal exclusion criteria

1. >24 hrs from ICU admission to time of consent
2. Low level of inflammatory cytokine (IL-6 <100 pg/ml)
3. Patients who are moribund (not expected to b in ICU fr more than 48 hours due to imminent death)
4. Metastatic Cancer or stage IV Lymphoma wit life expectancy < 6 months
5. A lack of commitment to full aggressive care (anticipated withholding or withdrawing treatments in the first week)
6. Immnuocompromised (post-organ transplantation, HIV, neutropenic [<1000 absolute neutrophils], corticosteroids >20 mgs/day for 6 months)
7. Chronic non-invasive ventilation (except if becomes invasively mechanically ventilated)
8. History of bleeding disorders or Platelet count of <30 x 109/L
9. Pregnant patients
10. Previous enrolment in this study.
11. Enrolment in other ICU interventional study
12. Allergy to fish or fish oil (shellfish allergy not an exclusion criterion) or egg
13. Has already received enteral or IV omega-3 fatty acids during the current ICU admission

E.5 End points

E.5.1

Primary end point(s)

E.5.1.1

Timepoint(s) of evaluation of this end point

Daily and at the end of a 28day period

E.5.2

Secondary end point(s)

E.5.2.1

Timepoint(s) of evaluation of this end point

Daily and at the end of a 28day period

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

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

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)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

dose escalating study

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

standard care vs. two dosages

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

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

Yes

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

See protocol chapter 3.4 Outcome measures

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

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

Yes

F.3.3.6

Subjects incapable of giving consent personally

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

Patients with septic shock probably being analgosedated on ventilator therapy

Patienten mit Septischem Schock sind in der Regel in künstlichem Koma beatmet auf der Intensivstation

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)

Further follow up until day 28

Weiterbeobachtung bis zum Tag 28

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

2012-05-25

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-01-09

P. End of Trial
P.	End of Trial Status	Prematurely Ended
P.	Date of the global end of the trial	2017-12-15

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