Clinical Trials Register

Summary
EudraCT Number:	2018-002715-10
Sponsor's Protocol Code Number:	FAR-NP-2018-01
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2018-11-16
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

Spain - AEMPS

A.2

EudraCT number

2018-002715-10

A.3

Full title of the trial

RANDOMIZED, DOUBLE-BLIND, PILOT CLINICAL TRIAL TO COMPARE THE EFFICACY AND SAFETY OF FISH OIL-BASED INTRAVENOUS LIPID EMULSIONS IN HOSPITALIZED ADULT PATIENTS TREATED WITH TOTAL PARENTERAL NUTRITION WITH HYPERTRIGLYCERIDEMIA

ENSAYO CLÍNICO PILOTO, RANDOMIZADO, DOBLE CIEGO, PARA COMPARAR LA EFICACIA Y SEGURIDAD DE LAS EMULSIONES LIPÍDICAS ENDOVENOSAS DE ACEITE DE PESCADO EN PACIENTES ADULTOS HOSPITALIZADOS TRATADOS CON NUTRICIÓN PARENTERAL TOTAL CON HIPERTRIGLICERIDEMIA

A.3.1

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

CLINICAL TRIAL TO COMPARE THE EFFICACY AND SAFETY OF FISH OIL-BASED INTRAVENOUS LIPID EMULSIONS IN HOSPITALIZED ADULT PATIENTS TREATED WITH TOTAL PARENTERAL NUTRITION WITH HIGH TRIGLYCERIDES IN BLOOD

ENSAYO CLÍNICO PARA COMPARAR LA EFICACIA Y SEGURIDAD DE LAS EMULSIONES LIPÍDICAS DE ACEITE DE PESCADO EN PACIENTES ADULTOS HOSPITALIZADOS TRATADOS CON NUTRICIÓN PARENTERAL TOTAL CON TRIGLICERIDOS ELEVADOS EN SANGRE

A.4.1

Sponsor's protocol code number

FAR-NP-2018-01

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	Elisabet Leiva Badosa. Phamacy Department. Hospital Universitari de Bellvitge
B.1.3.4	Country	Spain
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	Hospital Universitari de Bellvitge - Instituto de Investigación Biomédica de Bellvitge (Idibell)
B.4.2	Country	Spain
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Hospital Universitari de Bellvitge
B.5.2	Functional name of contact point	Elisabet Leiva Badosa
B.5.3	Address:
B.5.3.1	Street Address	Feixa Llargna s/n
B.5.3.2	Town/ city	L'Hospitalet de Llobregat
B.5.3.3	Post code	08901
B.5.3.4	Country	Spain
B.5.6	E-mail	eleiva@bellvitgehospital.cat

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
D.2.1.1.2	Name of the Marketing Authorisation holder	Fresenius Kabi
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
D.3.4	Pharmaceutical form	Emulsion for injection
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	EICOSAPENTANOIC ACID/DOCOSAHEXAENOIC ACID
D.3.9.3	Other descriptive name	Fish oil
D.3.9.4	EV Substance Code	SUB28845
D.3.10	Strength
D.3.10.1	Concentration unit	% (W/V) percent weight/volume
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	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	Clinoleic
D.2.1.1.2	Name of the Marketing Authorisation holder	Baxter
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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	Clinoleic
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	REFINED OLIVE OIL AND REFINED SOYA OIL
D.3.9.3	Other descriptive name	Oil/Soybean oil
D.3.9.4	EV Substance Code	SUB32333
D.3.10	Strength
D.3.10.1	Concentration unit	% (W/V) percent weight/volume
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	20
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	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

Hypertriglyceridemia is a frequent metabolic complication associated with the administration of lipidic emulsion in total parenteral nutrition.

La hipertrigliceridemia es una complicación metabólica frecuente asociada a la administración de emulsiones lipídicas en la nutrición parenteral total.

E.1.1.1

Medical condition in easily understood language

Elevation of plasma triglycerides is a frequent complication associated with the administration of fats in parenteral nutrition.

La elevación de los trigliceridos en plasma es una complicación frecuente asociada a la administración de grasas en la nutrición parenteral.

E.1.1.2

Therapeutic area

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

MedDRA Classification

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

In hospitalized adult patients treated with parenteral nutrition who have hypertriglyceridemia (> 3 mmol / L) after the administration of a lipid emulsion with olive oil/soybean standard at 0.8 g/kg/day, the main objective is to determine whether the change to lipidic emulsion of fish oil (100% ω-3 fatty acids) maintaining the same dose is equally effective in reducing triglycerides at 3, 7 and 14 days of treatment, and 3 days after starting the oral intake, than the reduction of the contribution to 0.5 g / kg / day in the emulsion of olive oil/soy or fish oil lipid emulsion 50:50 olive oil keeping the same dose.

En pacientes adultos hospitalizados tratados con nutrición parenteral que presentan hipertrigliceridemia (> 3 mmol / L) tras la administración de una emulsión lipídica con patrón aceite oliva/soja a 0.8 g/kg/día, el objetivo principal es determinar si el cambio a emulsión lipídica de aceite de pescado (100% ácidos grasos ω-3) manteniendo la misma dosis es igual de efectiva en la reducción de trigliceridos a los 3, 7 y 14 días de tratamiento, y a los 3 días de iniciar la ingesta oral, que la disminución del aporte a 0.5 g/kg/día en la emulsión de aceite de oliva/soja o emulsión lipídica de aceite de pescado:aceite de oliva 50:50 manteniendo la misma dosis.

E.2.2

Secondary objectives of the trial

- Determine if the change to 0.8 g / kg / day of fish oil lipid emulsion (100% ω-3 fatty acids) or intravenous lipid emulsion of fish oil: 50:50 olive oil maintaining the same dose, at 3, 7 and 14 days of treatment and 3 days after starting the oral intake, with respect to the reduction of the contribution to 0.5g / kg / day in the emulsion of olive oil: soy improves the nutritional parameters (albumin, prealbumin and lymphocytes), improves the inflammatory parameters (PCR, Il-6, Il-9, Il-10 and TNF-alpha), reduces the levels of plasma phytosterols and improves the lipid profile of patients (cholesterol, VLDL, HDL, HDL, APO-B);
- To determine the association between a reduction of plasmatic phytosterols with the polymorphisms rs11887534, rs4245791, rs41360247, rs4148217, and rs657152.

- Determinar si el cambio a 0.8 g/kg/día de emulsión lipídica de aceite de pescado (100% ácidos grasos ω-3) o emulsión lipídica endovenosa de aceite de pescado:aceite de oliva 50:50 manteniendo la misma dosis, a los 3, 7 y 14 días de tratamiento y a los 3 días de iniciar la ingesta oral, con respecto a la disminución del aporte a 0.5g/kg/día en la emulsión de aceite de oliva:soja mejora los parámetros nutricionales (albúmina, prealbúmina y linfocitos), mejora los parámetros inflamatorios (PCR, Il-6, Il-9, Il-10 y TNF-alfa), reduce los niveles de fitoesteroles plasmáticos y mejora el perfil lipídico de los pacientes (colesterol, VLDL, HDL, HDL, APO-B);
- Determinar la asociación entre una reducción de los fitosteroles plasmáticos con los polimorfismos rs11887534, rs4245791, rs41360247, rs4148217, y rs657152.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Subjects must be 18 years of age or older and may be of both genders and of any race / ethnicity.
2. Subjects must be willing to give written informed consent for the trial and be able to do. Otherwise, it can be done by the legal representative.
3. Subjects should have triglyceride levels between 3 and 4.5 mmol / L and have been treated for at least 1 day with NP.

1. Los sujetos deberán tener 18 años o más y podrán ser de ambos sexos y de cualquier raza/etnia.
2. Los sujetos deberán estar dispuestos a otorgar su consentimiento informado por escrito por el ensayo y ser capaces de hacerlo. En caso contrario, podrá hacerlo el ser representante legal.
3. Los sujetos deberán tener unos niveles de triglicéridos entre 3 y 4.5 mmol/L y haber sido tratados durante al menos 1 día con NP.

E.4

Principal exclusion criteria

1. Subjects may not have a history of type I hypersensitivity or idiosyncratic reactions to any component of lipid emulsions.
2. Women who are pregnant or breast-feeding.
3. Subjects treated with propofol

1. Los sujetos no podrán tener antecedentes de hipersensibilidad de tipo I ni de reacciones idiosincrásicas a ningún componente de las emulsiones lipídicas.
2. Mujeres embarazadas o en período de lactancia.
3. Sujetos tratados con propofol

E.5 End points

E.5.1

Primary end point(s)

Temporal variation of plasma triglycerides and will be collected on day 0 (day of randomization) and on days 3, 7 and 14 post-randomization and 3 days after starting the oral intake

Variación temporal de los triglicéridos plasmáticos y se recogerá el día 0 (día de randomización) y los días 3, 7 y 14 postrandomización, y a los 3 días de iniciar la ingesta oral.

E.5.1.1

Timepoint(s) of evaluation of this end point

Planned start date: 09/24/2018
Expected completion date: 09/30/2021

Fecha prevista de inicio: 24/09/2018
Fecha prevista de finalización: 30/09/2021

E.5.2

Secondary end point(s)

- Nutritional parameters: Albumin, prealbumin, lymphocytes and glucose
- Inflammatory parameters: C-reactive protein (CRP), Il-6, Il-10 and TNF-alpha
- Plasma phytosterols
- Polymorphisms: rs11887534, rs41360247, rs4245791i rs657152
- Lipid profile: total cholesterol, VLDL, HDL, LDL, APO-B
- Safety parameters: platelet count and prothrombin time
- Liver parameters: gamma-glutamyl transferase, alkaline phosphatase, alanine amino transferase and total bilirubin
- Parameters of renal function: Creatinine, Urea

-Parámetros nutricionales: Albúmina, prealbúmina, Linfocitos y glucosa
-Parámetros inflamatorios: Proteína C reactiva (PCR), Il-6, Il-10 y TNF-alfa
-Fitoesteroles plasmáticos
-Polimorfismos: rs11887534, rs41360247, rs4245791i rs657152
-Perfil lipídico: colesterol total, VLDL, HDL, LDL, APO-B
-Parámetros de seguridad: recuento de plaquetas y tiempo de protrombina
-Parámetros hepáticos: gamma-glutamil transferasa, Fosfatasa alcalina, alanina amino transferasa y bilirrubina total
-Parámetros de función renal: Creatinina, Urea

E.5.2.1

Timepoint(s) of evaluation of this end point

Planned start date: 09/24/2018
Expected completion date: 09/30/2021

Fecha prevista de inicio: 24/09/2018
Fecha prevista de finalización: 30/09/2021

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

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

Yes

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

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)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

emulsión lipídica con patrón oliva/soja

olive/soy fatty acids

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

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

The trial will finished at the end of the last visit of the last patient included.

El ensayo finalizará después del seguimiento del último paciente recultado

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

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

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

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)

None

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

2019-02-08

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-01-31

P. End of Trial
P.	End of Trial Status	Ongoing

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