Clinical Trials Register

Summary
EudraCT Number:	2013-005487-26
Sponsor's Protocol Code Number:	AI468-038
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2018-02-21
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

2013-005487-26

A.3

Full title of the trial

A Phase 2b Randomized, Active-Controlled, Double-Blind Trial to Investigate Safety, Efficacy and Dose-response of BMS-955176, Given on a
Backbone of Tenofovir/Emtricitabine, in Treatment-Naive HIV-1 Infected Adults

Studio di Fase 2B randomizzato, controllato, in doppio cieco, per valutare sicurezza, efficacia e risposta alla dose relative al farmaco BMS-955176, somministato in aggiunta ad una terapia di base con Tenofovir/Emtricitabina nel trattamento di soggetti adulti infetti da HIV-1 naive al trattamento.

A.3.1

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

Study to find at least one dose of BMS-955176 that will be safe, effective
and tolerable in HIV-1 infected treatment naive adults

Studio per trovare almeno una dose di BMS-955176 che sia sicura, efficace e tollerabile nei soggetti adulti infetti da virus HIV-1 naive al trattamento.

A.3.2

Name or abbreviated title of the trial where available

Dose-finding study of BMS-955176 in HIV-1 Infected treatment-naive

Studio dose-finding di BMS-955176 nei soggetti adulti infetti da virus HIV-1 naive al trattamento

A.4.1

Sponsor's protocol code number

AI468-038

A.5.1

ISRCTN (International Standard Randomised Controlled Trial) Number

ISRCTN00000000

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT00000000

A.5.3

WHO Universal Trial Reference Number (UTRN)

U1111-1161-2094

A.5.4

Other Identifiers

Name:

Number:

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	BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION
B.1.3.4	Country	Belgium
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	Bristol-Myers Squibb International Corporation
B.4.2	Country	Belgium
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Bristol-Myers Squibb International Corporation
B.5.2	Functional name of contact point	GCT-SU
B.5.3	Address:
B.5.3.1	Street Address	Parc de l'Alliance, Avenue de Finlande, 4
B.5.3.2	Town/ city	Braine l'Alleud
B.5.3.3	Post code	1420
B.5.3.4	Country	Belgium
B.5.4	Telephone number	000000
B.5.5	Fax number	000000
B.5.6	E-mail	clinical.trials@bms.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	No
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	NA
D.3.2	Product code	BMS-955176
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
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	BMS-955176-03
D.3.9.4	EV Substance Code	SUB33206
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	60
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: 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	No
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	NA
D.3.2	Product code	BMS-955176
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
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	BMS-955176-03
D.3.9.4	EV Substance Code	SUB33206
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	120
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	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	SUSTIVA - 600 MG COMPRESSE FILM RIVESTITE 1 FLACONE 30 COMPRESSE USO ORALE
D.2.1.1.2	Name of the Marketing Authorisation holder	BRISTOL-MYERS SQUIBB PHARMA EEIG
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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	sustiva
D.3.2	Product code	BMS-561525
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
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	EFAVIRENZ
D.3.9.2	Current sponsor code	154598-52-4
D.3.9.3	Other descriptive name	EFAVIRENZ
D.3.9.4	EV Substance Code	SUB06463MIG
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	600
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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Film-coated tablet
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Film-coated tablet
D.8 Placebo: 3
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Film-coated tablet

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

HIV

E.1.1.1

Medical condition in easily understood language

HIV

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	20.1
E.1.2	Level	LLT
E.1.2	Classification code	10068341
E.1.2	Term	HIV-1 infection
E.1.2	System Organ Class	100000004862

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 antiviral efficacy of 3 doses (60, 120 and 180 mg) of BMS-
955176, and EFV, each when given in combination with TDF/FTC in
treatment-naïve subjects by determining the proportion of treatmentnaïve
subjects with plasma HIV-1 RNA < 40 c/mL at Week 24

Valutare l’efficacia antivirale di 3 dosi (60, 120 and 180 mg) di BMS-955176, e di EFV, ciascuna somministrata in combinazione con TDF/ FTC in soggetti naïve al trattamento, mediante la determinazione della proporzione di soggetti naive al trattamento con HIV-1 RNA plasmatico < 40 c/mL alla Settimana 24.

E.2.2

Secondary objectives of the trial

- To assess the antiviral efficacy of BMS-955176 and EFV by determining
the proportion of subjects with plasma
HIV-1 RNA < 40 c/mL at Weeks 48, and 96
- To assess the antiviral efficacy of BMS-955176 and EFV by determining
the proportion of subjects with plasma
HIV-1 RNA < 200 c/mL at Weeks 24, 48, and 96
- To assess the emergence of HIV drug resistance among samples
selected for drug resistance testing
- To assess efficacy of BMS-955176 and EFV, by using mean changes
from baseline in log10 HIV-1 RNA, CD4+ T-cell counts, and percentage of
CD4+ T-cells
- To assess the safety and tolerability of BMS-955176 in treatment-naïve
subjects by measuring frequency of SAEs and AEs leading to
discontinuation
- To assess disease progression as measured by the occurrence of new
AIDS defining events (CDC Class C events)
- To characterize the pharmacokinetics of BMS-955176 when coadministered
with TDF and FTC in treatment-naïve HIV-1 infected
subjects.

1. Valutare l’efficacia antivirale di BMS-955176 e EFV determinando la proporzione di soggetti con HIV-1 RNA plasmatico < 40 c/mL alle Settimane 48 e 96
2. Valutare l’efficacia antivirale di BMS-955176 e EFV mediante la determinazione della proporzione di soggetti con HIV-1 RNA plasmatico < 200 c/mL alle Settimane 24, 48 e 96
3. Valutare l’insorgenza di resistenza al farmaco HIV tra campioni selezionati per il test di farmaco resistenza
4. Valutare l’efficacia di BMS-955176 e EFV, utilizzando i cambiamenti medi dal basale in log10 HIV-1 RNA, conta cellule T CD4+, e percentuale di cellule T CD4+
5. Valutare la sicurezza e la tollerabilità di BMS-955176 nel trattamento di soggetti naïve misurando la frequenza di SAEs eAEs che portano a interruzione definitiva del farmaco
6. Valutare la progressione di malattia misurata dalla insorgenza di nuovi eventi che definiscono AIDS (CDC eventi Class C)
7. Caratterizzare la farmacocinetica di BMS-955176 quando somministrato insieme a T

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

Optional Week 2 Intensive PK Substudy:
Subjects with anemia, defined as Hemoglobin < 11.0 g/dL, should be
excluded from participation in the Week 2 Intensive PK Substudy.
Subjects in all arms will have the opportunity to participate in an elective
Intensive PK Substudy visit at Week 2 (window for visit: Day 12-16).
Approximately 48 subjects, 12 subjects from each arm, are expected to
participate in the substudy; BMS may allow the substudy to over-enroll
in an effort to have a sufficient number of complete datasets.

Sottostudio facoltativo di PK intensiva alla Settimana 2.
Dovrebbero essere esclusi dalla partecipazione al sottostudio di PK intensiva alla Settimana 2 i soggetti con anemia, definita come emoglobina <11.0 g/dL. I soggetti in tutti i bracci di trattamento avranno l’opportunità di partecipare ad una visita elettiva per il sottostudio di PK intensiva alla Settimana 2 (finestra per la visita: Giorno 12-16). E’ attesa la partecipazione nel sottostudio di circa 48 soggetti, 12 soggetti da ogni braccio di trattamento; BMS può consentire che il sottostudio abbia un arruolamento superiore nel tentativo di avere un numero sufficiente di dati completi.

E.3

Principal inclusion criteria

- Men and non-pregnant women, at least 18 years of age
- Antiretroviral treatment-naïve; defined as no current or previous
exposure to > 1 week of an antiretroviral drug
Plasma HIV-1 RNA > or = to 1000 copies/mL
- CD4 T-cell count > 200 cells/mm3

- Uomini e donne non in stato di gravidanza, di almeno 18 anni di età
- Naive al trattamento antiretrovirale; definito come non attuale o precedente esposizione a > 1 settimana di farmaco antiretrovirale HIV-1 RNA plasmatico > o = 1000 copie/mL
- Numero di cellule T CD4 > 200/mm3

E.4

Principal exclusion criteria

- Resistance or partial resistance to any study drug determined by tests
at Screening
- Current or historical genotypic and/or phenotypic drug resistance
testing showing certain resistance mutations to EFV, TDF, FTC, Protease
Inhibitors, (Please see protocol for further information on these
exclusionary mutations)
- Chronic HBV/HCV
- Blood tests that inidcate normal liver function (see protocol)
- Hemoglobin < 8.0 g/dL and Platelets < 50,000 cells/mm3

- Resistenza o parziale resistenza a qualsiasi farmaco in studio determinate da test allo Screening
- Test di resistenza ai farmaci genotipica e/o fenotipica attuale o storica che mostri alcune mutazioni che conferiscono resistenza a EFV, TDF, FTC, Inibitori delle Proteasi (si prega di riferirsi al protocollo per ulteriori informazioni su queste mutazioni che causano esclusione)
- HBV/HCV cronico
- Test ematici che indicano funzionalità epatica anormale (si prega di riferirsi al protocollo )
- Emoglobina < 8.0 g/dL e Piastrine < 50,000 cell/mm3

E.5 End points

E.5.1

Primary end point(s)

The primary endpoint is the proportion of subjects with plasma HIV-1
RNA < 40 c/mL at Week 24. This will be conducted as a sensitivity
analysis that compliments the snapshot analysis. This uses the last on
treatment plasma HIV-1 RNA measurement within an FDA-specified visit
window to determine response.

L’Endpoint Primario è la proporzione di soggetti con HIV-1 RNA plasmatico < 40 c/mL alla Settimana 24. Questo verrà condotto mediante un’analisi di sensibilità che complementi l’analisi snapshot. Per determinare la risposta questo algoritmo usa l’ultima misurazione di HIV-1 RNA plasmatico entro una finestra temporale di visita specificata da FDA

E.5.1.1

Timepoint(s) of evaluation of this end point

24 weeks

Settimana 24

E.5.2

Secondary end point(s)

The antiviral efficacy will also be assessed by the proportion of
subjects with plasma HIV-1 RNA < 200 c/mL at Weeks 24, 48, and 96
using the FDA snapshot algorithm approach with positive response
defined as HIV-1 RNA < 200 c/mL

L’efficacia antivirale verrà valutata anche dalla proporzione di soggetti con HIV-1 RNA plasmatico
<200 c/mL alle Settimane 24, 48 e 96 utilizzando l’approccio dell’ algoritmo FDA snapshot con risposta
positiva definita come HIV-1 RNA < 200 c/mL

E.5.2.1

Timepoint(s) of evaluation of this end point

at Weeks 24, 48 and 96

Settimane 24, 48 e 96

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

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

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

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)

Yes

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

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

Argentina

Canada

Chile

Mexico

South Africa

Thailand

United States

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

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

Number of subjects for this age range:

F.1.1.1

In Utero

Information not present in EudraCT

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

Information not present in EudraCT

F.1.1.3

Newborns (0-27 days)

Information not present in EudraCT

F.1.1.4

Infants and toddlers (28 days-23 months)

Information not present in EudraCT

F.1.1.5

Children (2-11years)

Information not present in EudraCT

F.1.1.6

Adolescents (12-17 years)

Information not present in EudraCT

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

278

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

Yes

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.4.2

For a multinational trial

F.4.2.1

In the EEA

150

F.4.2.2

In the whole clinical trial

300

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)

At the conclusion of the study, subjects who continue to demonstrate
clinical benefit will be eligible to receive BMS supplied study drug.
Study drug will be provided via an extension of the study, a rollover
study requiring approval by responsible HA and EC or through another
mechanism at the discretion of BMS. BMS reserves the right to
terminate access to BMS supplied study drug in the situations listed in
section 3.2 of the protocol.

A conclusione dello studio, i soggetti che continuassero a dimostrare beneficio clinico, saranno eleggibili a ricevere il farmaco in studio BMS. Il farmaco in studio BMS verrà fornito tramite una estensione dello studio, uno studio di roll-over che richiede approvazione da parte di HA e Comitato Etico oppure tramite un altro meccanismo, a discrezione di BMS. BMS si riserva il diritto di terminare l’accesso al farmaco BMS in studio nelle situazioni elencate nella sezione 3.2 del protocollo.

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

2015-07-10

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-09-10

P. End of Trial
P.	End of Trial Status	Prematurely Ended
P.	Date of the global end of the trial	2016-09-28

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Clinical trials