Clinical Trials Register

Summary
EudraCT Number:	2011-002122-43
Sponsor's Protocol Code Number:	MICI2011-01
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2012-03-07
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

Italy - Italian Medicines Agency

A.2

EudraCT number

2011-002122-43

A.3

Full title of the trial

Iron therapy in IBD patients with normal levels of haemoglobin and chronic fatigue

Effetti della terapia marziale in pazienti con fatica cronica e IBD

A.3.1

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

Iron therapy in IBD patients with normal levels of haemoglobin and chronic fatigue

Effetti della terapia marziale in pazienti con fatica cronica e IBD

A.4.1

Sponsor's protocol code number

MICI2011-01

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	ISTITUTO CLINICO HUMANITAS
B.1.3.4	Country	Italy
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	Istituto Clinico Humanitas
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Istituto Clinico Humanitas
B.5.2	Functional name of contact point	Ufficio Sperimentazioni Cliniche
B.5.3	Address:
B.5.3.1	Street Address	via Manzoni 56
B.5.3.2	Town/ city	Rozzano
B.5.3.3	Post code	20089
B.5.3.4	Country	Italy
B.5.4	Telephone number	02 82244033
B.5.5	Fax number	02 82247208
B.5.6	E-mail	francesco.minuti@humanitas.it

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	ferinject
D.2.1.1.2	Name of the Marketing Authorisation holder	VIFOR FRANCE S.A.
D.2.1.2	Country which granted the Marketing Authorisation	France
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	Concentrate for solution 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	Ferric Carboxymaltose
D.3.9.4	EV Substance Code	NA
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	50
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	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

patients with IBD and chronic fatigue

pazienti con fatica cronica e IBD

E.1.1.1

Medical condition in easily understood language

patients with IBD and chronic fatigue

pazienti con fatica cronica e IBD

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	14.1
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

E.2 Objective of the trial

E.2.1

Main objective of the trial

chronic fatigue remission (MFI-20 <13)

remissione della fatica cronica (MFI-20 <13)

E.2.2

Secondary objectives of the trial

Clinical response, defined as decrease in MFI-20 of at least 4 points, but with a score > 13

risposta della fatica cronica (diminuzione MFI-20 di ≥4 punti) evoluzione dell’ansia e depressione e cambiamento della qualita' di vita alla settimana 4, 12 e 24 dall’inizio della somministrazione di ferro o placebo mediante i questionari appositi

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Man and women, 18 years of age or older. - Female subjects must utilize a highly effective method of birth control throughout the study. - At least 12-month history of IBD. - Inactive Crohn’s disease or Ulcerative colitis (HB: <5, Mayo Clinical Score: ≤ 2) since at least 6 months - Chronic fatigue symptoms (Mfi-20 > 13). - Concurrent stable doses of 5-aminosalicylate, azathioprine, methotrexate or anti TNFα. - Iron deficiency: ferritin< 100 ng/ml or ferritin 100-300 ng/ml when transferring saturation (TSAT) < 20%.

• Pazienti maschi e femmine, di eta' compresa tra i 18 e i 75 anni. • Tutte le donne in eta' fertile devono avere un test di gravidanza su siero negativo immediatamente prima dell’arruolamento • Diagnosi di RCU o MC da piu' di 12 mesi, confermata con esami endoscopici e/o di imaging. • Remissione clinica (HB<5 ; Mayo clinical score ≤2 ) da almeno 6 mesi. • Sintomi da fatica cronica (Mfi-20 > 13). • Carenza marziale: ferritina< 100 microg/l o < 300 microg/l se percentuale di saturazione transferrina < 20%.

E.4

Principal exclusion criteria

- Known hypersensitivity to iron sucrose or to its excipients. - Pregnancy: women with childbearing potential must not become pregnant during the study. - Clinically active IBD and /or C-reactive protein >2.5. - Comorbidity possibly resulting in (additional) fatigue (e.g., kidney or adrenal insufficiency, autoimmune diseases, malignancy, depression, a recent viral infection, or psychotrauma psychic diseases, included depression. - Anaemia (Hb:< 12.5 in male and < 11.5 in female

• Hb:< 12.5 negli uomini; < 11.5 nelle donne • Ipersensibilita` conosciuta al principio attivo o ad uno qualsiasi degli eccipienti. • Donne in gravidanza o in allattamento. • Malattia attiva clinicamente e/o PCR>2.5. • Insufficienza renale. • Insufficienza surrenale. • Malattie autoimmuni.

E.5 End points

E.5.1

Primary end point(s)

chronic fatigue remission

remissione della fatica cronica

E.5.1.1

Timepoint(s) of evaluation of this end point

24 weeks

24 settimane

E.5.2

Secondary end point(s)

chronic fatigue response

risposta alla fatica cronica

E.5.2.1

Timepoint(s) of evaluation of this end point

24 weeks

24 settimane

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

E.6.4

Safety

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

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

Yes

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)

E.8.2.2

Placebo

Yes

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.8.4.1

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

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

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1

Number of subjects for this age range:

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

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)

standard care

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

2011-07-06

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-05-17

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

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