Clinical Trials Register

Summary
EudraCT Number:	2006-000977-31
Sponsor's Protocol Code Number:	NV25361
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2021-05-24
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

Italy - Italian Medicines Agency

A.2

EudraCT number

2006-000977-31

A.3

Full title of the trial

PHASE IIIB, RANDOMIZED, OPEN LABEL STUDY OF PEGYLATED INTERFERON ALFA-2A IN COMBINATION WITH LAMIVUDINE OR
ENTECAVIR COMPARED WITH UNTREATED CONTROL PATIENTS IN CHILDREN WITH HBEAG POSITIVE CHRONIC HEPATITIS B IN THE IMMUNE
TOLERANT PHASE

STUDIO DI FASE IIIB, RANDOMIZZATO, IN APERTO, CON INTERFERONE PEGILATO ALFA-2A IN ASSOCIAZIONE A LAMIVUDINA O ENTECAVIR,
RISPETTO AL CONTROLLO DI PAZIENTI SENZA
TRATTAMENTO, IN BAMBINI AFFETTI DA EPATITE B CRONICA HBEAG-POSITIVA IN FASE
IMMUNOTOLLERANTE

A.3.1

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

A Study of Pegasys in Combination with antiviral HBV oral Lamivudine or entecavir compared against no treatment in Children Positive but
tolerant to Chronic Hepatitis B.

STUDIO CON INTERFERONE PEGILATO ALFA-2A O ENTECAVIR IN ASSOCIAZIONE
A LAMIVUDINA

A.3.2

Name or abbreviated title of the trial where available

STUDY OF PEGYLATED INTERFERON ALFA-2A IN COMBINATION WITH LAMIVUDINE

STUDIO CON INTERFERONE PEGILATO ALFA-2A IN ASSOCIAZIONE A LAMIVUDINA

A.4.1

Sponsor's protocol code number

NV25361

A.7

Trial is part of a Paediatric Investigation Plan

Yes

A.8

EMA Decision number of Paediatric Investigation Plan

P/010/2016

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	F. HOFFMANN - LA ROCHE LTD.
B.1.3.4	Country	Switzerland
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	F. Hoffmann La Roche Ltd.
B.4.2	Country	Switzerland
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	F. Hoffmann-La Roche Ltd
B.5.2	Functional name of contact point	Trial Information Support Line-TISL
B.5.3	Address:
B.5.3.1	Street Address	Grenzacherstrasse 124
B.5.3.2	Town/ city	Basel
B.5.3.3	Post code	4070
B.5.3.4	Country	Switzerland
B.5.4	Telephone number	0
B.5.5	Fax number	0
B.5.6	E-mail	global.rochegenentechtrials@roche.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	Pegasys
D.2.1.1.2	Name of the Marketing Authorisation holder	Roche Registration Ltd
D.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
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	Pegasys
D.3.2	Product code	RO025-8310
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	Yes
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	INTERFERONE ALFA-2A PEGILATO
D.3.9.1	CAS number	76543-88-9
D.3.9.2	Current sponsor code	Ro025-8310/J13
D.3.9.3	Other descriptive name	Interferon alfa-2a
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	180
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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	Yes
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	Immunostimulating agent/cytokine
D.IMP: 2
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	Epivir
D.2.1.1.2	Name of the Marketing Authorisation holder	ViiV Healthcare UK Ltd.
D.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
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	Oral solution
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	LAMIVUDINA
D.3.9.1	CAS number	134678-17-4
D.3.9.2	Current sponsor code	-
D.3.9.3	Other descriptive name	LAMIVUDINE
D.3.9.4	EV Substance Code	SUB08392MIG
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	10
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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: 3
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	Lamivudine
D.2.1.1.2	Name of the Marketing Authorisation holder	TEVA Pharma B.V
D.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
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	Film-coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	LAMIVUDINA
D.3.9.1	CAS number	134678-17-4
D.3.9.2	Current sponsor code	-
D.3.9.3	Other descriptive name	LAMIVUDINE
D.3.9.4	EV Substance Code	SUB08392MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
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	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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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 Hepatitis B Virus infection in children.

infezione da virus dell'epatite C cronica in bambini

E.1.1.1

Medical condition in easily understood language

Chronic Hepatitis B in immune-tolerant phase with high levels of hepatitis B virus in the blood and low (if any) liver damage

Epatite B cronica in fase immuno-tollerante con alti livelli di virus dell'epatite B nel sangue e (se del caso) con danno non grave al fegato

E.1.1.2

Therapeutic area

Diseases [C] - Virus Diseases [C02]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10019743
E.1.2	Term	Hepatitis B virus (HBV)
E.1.2	System Organ Class	100000004848

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 evaluate the efficacy of Pegasys¿ + lamivudine compared with an untreated control in children with CHB, as measured by loss of HBsAg 24 weeks post-end of treatment/end of untreated observation.

Valutare l'efficacia di Pegasys¿ + lamivudina rispetto a un controllo senza trattamento in bambini affetti da epatite B cronica (CHB), misurandola in termini di perdita di HBsAg 24 settimane dopo la fine del trattamento/fine dell'osservazione senza trattamento.

E.2.2

Secondary objectives of the trial

¿To evaluate efficacy of Pegasys¿ + lamivudine compared with an untreated control in children with CHB, as measured by seroconversion to anti-HBs, seroconversion to anti-HBe, loss of HBeAg, and HBV DNA levels, at 24 weeks post-end of treatment/end of untreated observation
¿ To evaluate efficacy of Pegasys¿ + lamivudine in children with CHB, as measured by seroconversion to anti-HBs, seroconversion to anti-HBe, loss of HBsAg, loss of HBeAg, HBV DNA levels, and at 1, 2, 3, 4, and 5 years post-end of treatment

-Valutare l'efficacia di Pegasys¿ + lamivudina rispetto a un controllo senza trattamento in bambini affetti da epatite B cronica (CHB), misurandola in termini di sieroconversione ad anti-HBs, sieroconversione ad anti-HBe, perdita di HBeAg e dei livelli di HBV DNA 24 settimane dopo la fine del trattamento/fine dell'osservazione senza trattamento.
- Valutare l'efficacia di Pegasys¿ + lamivudina in bambini affetti da epatite B cronica (CHB), misurandola in termini di sieroconversione ad anti-HBs, sieroconversione ad anti-HBe, perdita di HBsAg, perdita di HBeAg, e dei livelli di HBV DNA a 1, 2, 3, 4 e 5 anni dopo la fine del trattamento.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Male and female patients 3 to less than 18 years of age at baseline (12– 17 years of age at baseline in Russia)
• Positive for HBsAg and HBeAg for more than 6 months prior to baseline
• Detectable HBV-DNA (> 10,000 copies/mL [> 2000 IU/mL]) (as measured by PCR or hybridization) on at least 2 occasions at least one month apart with the latest determination obtained = 42 days prior to
baseline.

- Pazienti di entrambi i sessi, di età inferiore ai 18 anni al basale (o tra 12 e 17 anni di età al basale in Russia).
- Positivi per HBsAg e HBeAg per oltre 6 mesi prima del basale.
- HBV DNA rilevabile (> 10.000 copie/ml [> 2000 UI/ml]) (valore misurato mediante reazione a catena della polimerasi [PCR] o ibridazione) in almeno 2 occasioni distanziate di almeno un mese, con l'ultima determinazione ottenuta = 42 giorni prima del basale.

E.4

Principal exclusion criteria

Patients who have had any previous anti-HBV treatment, or who are co-infected with hepatitis A virus (HAV), HCV, hepatitis D virus (HDV) or HIV, or who have decompensated liver disease will be excluded.

Vengono esclusi pazienti trattati con altri trattamenti anti-HBV o co-infettati dal virus dell'epatite A (HAV), HCV, virus dell'epatite D (HDV), HIV, o che hanno epatopatia non compensata

E.5 End points

E.5.1

Primary end point(s)

The primary efficacy endpoint is defined as loss of HBsAg at 24 weeks post-end of treatment (follow-up Week 24)/end of untreated observation (Week 80).

L'endpoint primario di efficacia è la perdita di HBsAg a 24 settimane dopo la fine del trattamento (follow-up Week 24) /fine dell'osservazione senza trattamento (Week 80).

E.5.1.1

Timepoint(s) of evaluation of this end point

Please refer to E.5.1

Vedere sezione E.5.1

E.5.2

Secondary end point(s)

- Seroconversion to anti-HBs (loss of HBsAg and presence of anti-HBs)
- Seroconversion to anti-HBe (loss of HBeAg and presence of anti-HBe)
- Loss of HBeAg
- HBV DNA DNA < 100,000 copies/mL (< 20,000 IU/mL), < 10,000
copies/mL (< 2000 IU/mL) , undetectable and change from baseline (by PCR or hybridization)
- Combined endpoints: HBeAg seroconversion and HBV DNA < 100,000 copies/mL (< 20,000 IU/mL)
- Combined endpoints: HBeAg seroconversion and HBV DNA < 10,000 copies/mL (< 2000 IU/mL); - Seroconversion to anti-HBs (loss of HBsAg and presence of anti-HBs)
- Seroconversion to anti-HBe (loss of HBeAg and presence of anti-HBe)
- Loss of HBsAg
- Loss of HBeAg
- HBV DNA < 100,000 copies/mL (< 20,000 IU/mL), < 10,000 copies/mL (< 2000 IU/mL), undetectable and change from baseline (by PCR or hybridization)
- Combined endpoints: HBeAg seroconversion and HBV DNA < 100,000 copies/mL (< 20,000 IU/mL)
- Combined endpoints: HBeAg seroconversion and HBV DNA < 10,000 copies/mL (< 2000 IU/mL)

- Perdita di HBeAg
¿ Sieroconversione ad anti-HBs (perdita di HBsAg e presenza di anti-HBs)
¿ Sieroconversione ad anti-HBe (perdita di HBeAg e presenza di anti-HBe)
¿ HBV DNA < 100,000 copie/ml (< 20.000 UI/ml), < 10,000 copie/ml (< 2000 UI/ml), irrilevabile e variazione rispetto al basale (mediante PCR o ibridazione)
¿ Endpoint combinati: sieroconversione di HBeAg e HBV DNA < 100,000 copie/ml (< 20.000 UI/ml)
¿ Endpoint combinati: sieroconversione di HBeAg e HBV DNA < 10,000 copie/ml (< 2.000 UI/ml).; - Perdita di HBsAg
- Perdita di HBeAg
- Sieroconversione ad anti-HBs (perdita di HBsAg e presenza di anti-HBs)
- Sieroconversione ad anti-HBe (perdita di HBeAg e presenza di anti-HBe)
- HBV DNA < 100,000 copie/ml (< 20.000 UI/ml), < 10,000 copie/ml (< 2000 UI/ml), irrilevabile e variazione rispetto al basale (mediante PCR o ibridazione)
- Endpoint combinati: sieroconversione di HBeAg e HBV DNA < 100,000 copie/ml (< 20.000 UI/ml)
¿ Endpoint combinati: sieroconversione di HBeAg e HBV DNA < 10,000 copie/ml (< 2.000 UI/ml).

E.5.2.1

Timepoint(s) of evaluation of this end point

Please refer to E.5.2; Please refer to E.5.2

Fare riferimento alla sezione E 5.2; Fare riferimento alla sezione E 5.2

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

Yes

E.6.7

Pharmacodynamic

Yes

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)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

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

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

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

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Nessun trattamento

No treatment

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

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

China

Russian Federation

Taiwan

Turkey

Ukraine

Germany

Italy

Romania

United Kingdom

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

LVLS (the end of the study is defined as the date when the last patient, last visit for the final analysis occurs)

LVLS (per fine dello studio si intende la data in cui ha luogo l'ultima visita dell'ultimo paziente per l'analisi finale).

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

Yes

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)

Yes

F.1.1.5.1

Number of subjects for this age range:

F.1.1.6

Adolescents (12-17 years)

Yes

F.1.1.6.1

Number of subjects for this age range:

F.1.2

Adults (18-64 years)

F.1.3

Elderly (>=65 years)

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

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

Children from ages 3 to 17

Bambini dai 3 ai 17 anni

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

F.4.2.2

In the whole clinical trial

114

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)

All treated patients will be followed for 5 years after the end of treatment (24 weeks initial follow-up plus a further 4.5-year long-term follow-up) for evaluation of any longer-term effects of treatment.

Tutti i pazienti trattati verranno seguiti per 5 anni dopo la fine del trattmento (24 settimane di follow-up iniziale e altri 4,5 anni di follow-up a lungo termine) per la valutazione degli effetti del trattamento a lungo termine

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

2015-08-10

Ethics Committee Opinion of the trial application

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

P. End of Trial
P.	End of Trial Status	Completed

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Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
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