Clinical Trials Register

Summary
EudraCT Number:	2016-002958-21
Sponsor's Protocol Code Number:	HCV-art
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:	2021-06-08
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

2016-002958-21

A.3

Full title of the trial

Study HCV-art: An Open-Label, pilot Study, to Explore the Clinical Safety and Efficacy of Sofosbuvir/Ledipasvir in Hepatitis C Virus (HCV) Chronic Patients with Arthritis

Studio pilota, monocentrico, in aperto,
per valutare sicurezza ed efficacia
della combinazione sofosbuvir/ledipasvir
in pazienti con epatite C cronica, genotipo 1, affetti da artrite cronica

A.3.1

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

Study HCV-art: An Open-Label, pilot Study, to Explore the Clinical Safety and Efficacy of Sofosbuvir/Ledipasvir in Hepatitis C Virus (HCV) Chronic Patients with Arthritis

Studio pilota, monocentrico, in aperto,
per valutare sicurezza ed efficacia
della combinazione sofosbuvir/ledipasvir
in pazienti con epatite C cronica, genotipo 1, affetti da artrite cronica

A.3.2

Name or abbreviated title of the trial where available

HCV-art

A.4.1

Sponsor's protocol code number

HCV-art

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	AOU DI BOLOGNA POLICLINICO S.ORSOLA-MALPIGHI
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	Gilead
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	AOU di Bologna-Policlinico S.Orsola-Malpighi
B.5.2	Functional name of contact point	Programma Dipartimentale ITEC- Prof
B.5.3	Address:
B.5.3.1	Street Address	Via G. Massarenti 9
B.5.3.2	Town/ city	Bologna
B.5.3.3	Post code	40138
B.5.3.4	Country	Italy
B.5.4	Telephone number	051-2143618
B.5.5	Fax number	051-345806
B.5.6	E-mail	pietro.andreone@unibo.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	HARVONI - 90 MG/400 MG - COMPRESSE RIVESTITE CON FILM - USO ORALE - FLACONE (HDPE) - 28 COMPRESSE RIVESTITE CON FILM
D.2.1.1.2	Name of the Marketing Authorisation holder	GILEAD SCIENCES INTERNATIONAL LIMITED
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	HARVONI
D.3.2	Product code	J05AX65
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	SOFOSBUVIR
D.3.9.2	Current sponsor code	SOFOSBUVIR
D.3.9.3	Other descriptive name	SOFOSBUVIR 400mg- SPECIALITA' HARVONI
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	400
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	LEDIPASVIR
D.3.9.2	Current sponsor code	LEDIPASVIR
D.3.9.3	Other descriptive name	LEDIPASVIR 90MG-SPECIALITA' HARVONI
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	90
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	Yes
D.2.1.1.1	Trade name	REBETOL - 200 MG 84 CAPSULE RIGIDE IN BLISTER
D.2.1.1.2	Name of the Marketing Authorisation holder	MERCK SHARP e DOHME LIMITED
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	RIBAVIRINA
D.3.2	Product code	RIBAVIRINA
D.3.4	Pharmaceutical form	Capsule, hard
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	RIBAVIRINA
D.3.9.2	Current sponsor code	RIBAVIRINA
D.3.9.3	Other descriptive name	RIBAVIRINA
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	200
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 HCV associated with chronic arthritis.

HCV cronica associata ad artrite cronica.

E.1.1.1

Medical condition in easily understood language

Chronic HCV associated with chronic arthritis.

HCV cronica associata ad artrite cronica.

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	21.0
E.1.2	Level	LLT
E.1.2	Classification code	10066550
E.1.2	Term	Chronic arthritis
E.1.2	System Organ Class	100000004859

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.1
E.1.2	Level	PT
E.1.2	Classification code	10008912
E.1.2	Term	Chronic hepatitis C
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

1. Evaluate the efficacy of SOF/LDV¿RBV in achieving arthritis remission/improvement, at end of the antiviral treatment in patients with CHC genotype 1 (na¿ve and experienced) both with and without cirrhosis CHILD-A with both seropositive and seronegative arthritis.

1. Valutare l¿impatto della risposta virologica nell¿ottenere la remissione/miglioramento dell¿artrite alla fine della terapia antivirale nei pazienti con CHC genotipo 1 (sia mai- sia gi¿-trattati) con o senza cirrosi (CHILD - A) e con artrite cronica sieropositiva o sieronegativa.

E.2.2

Secondary objectives of the trial

1. Evaluate the safety of the combination SOF/LDV¿RBV for 12 weeks in HCV-positive (both treatment na¿ve and experienced including cirrhosis CHILD-A) genotype 1 patients with both seropositive and seronegative arthritis.

2. Evaluate the efficacy of SOF/LDV¿RBV in achieving arthritis remission/improvement, at week 24 after treatment withdrawal.
3. To evaluate HRQOL in a population of CHC patients with chronic arthritis at baseline and at 24 weeks post-treatment.

1- Valutare la sicurezza della combinazione a dose fissa (FDC) di SOFOSBUVIR / LEDIPASVIR ¿ RBV (SOF/LDV) per 12 settimane nei pazienti HCV- positivi genotipo 1 (sia mai- sia gi¿-trattati) con epatite cronica o con cirrosi ( CHILD - A ) e con artrite cronica sieropositivi o sieronegativi.
2- Valutare l¿impatto della risposta virologica sostenuta nell¿ottenere la remissione/miglioramento dell¿artrite alla 24¿ settimana dopo la sospensione del trattamento antivirale
3- Valutare HRQOL (qualit¿ della vita) in una popolazione di pazienti con epatite C e artrite cronica al basale, a fine trattamento ed a 24 settimane dopo la sospensione del trattamento antivirale

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Males or females, age > 18 years old
• HCV treatment-naïve or INF-experinced without directly acting antiviral drugs,
- Non-responder: The patient who had less than 2 log reduction of HCV-RNA after 12 weeks of antiviral treatment with IFN based regimen.
- Partial responder: Patient with reduction =2 log ofHCV-RNA after 12 weeks of antiviral treatment with IFN based regimen.
With persistence of positivity of HCV-RNA
- Relapser: patient with undeceteable HCV-RNA at the end of antiviral treatment with IFN based regimen but with relapse (HCV-RNA positive) after discontinuation of treatment.
• Chronic HCV infection documented by: a positive anti-HCV antibody test or positive HCV RNA or positive HCV genotyping test at least 6 months prior to the Baseline/Day 1 visit, or a liver biopsy performed prior to the Baseline/Day 1 visit with evidence of chronic HCV infection HCV RNA = 104 IU/mL at Screening
• Cirrhosis determination:
i) Liver biopsy showing cirrhosis (e.g. Metavir score = 4 or Ishak score = 5)
ii) FibroScan > 12.5 kPa
• Liver imaging within 6 months of Baseline/Day 1 to exclude hepatocellular carcinoma is required in patients with cirrhosis
• Radiological and laboratory diagnosis of inflammatory rheumatoid arthritis both seropositive (rheumatoid) and seronegative. serological positive and negative (RF+/-, anti-CCP +/-, cryo +/-)
• HCV genotype 1 at Screening.
• Screening ECG without clinically significant abnormalities
• Laboratory tests documenting ALT=10 the upper limit of normal (ULN), Direct bilirubin = 1.5 × ULN; Platelets= 50,000
• Hemoglobin = 10 g/dL for female, = 11 g/dL for male subjects.
• Albumin = 3g/dL
• INR = 1.5 x ULN
• Subject has not been treated with any investigational drug or device within 30 days of the Screening visit
• Contraception
- Female subjects (or the partner of a male subject) of childbearing potential must use effective contraception =1 method (=1% failure rate) during the study and up to seven months after discontinuation of RBV.
- Male subjects with female partners of childbearing potential must use adequate contraception during treatment with ribavirin and for 7 months after the end of treatment
- The effective contraception methods are those listed below:
¿ A double barrier method, (a) condom (male or female) or (b) diaphragm with spermicide;
¿ Intrauterine device;
¿ Vasectomy (partners);
¿ Hormonal (eg, contraceptive pill, patch, intramuscular injection or implant);
¿ Abstinence, abstinence is defined as abstaining from heterosexual relationships throughout the duration of therapy and up to seven months after discontinuation).

1. Maschi o femmine di età > 18 anni
2. Infezione da epatite C cronica documentata con: anti-HCV positivo e HCV-RNA positivo (>1000 UI/ml) da almeno 6 mesi prima del basale
3. Pazienti mai- o già- trattati con terapia a base di interferone ma senza farmaci antivirali ad azione diretta
-Classificazioni del paziente già trattato con fallimento terapeutico:
A. Non-responder: paziente che ha avuto una riduzione < 2 log di HCV-RNA dopo 12 settimane di trattamento antivirale a base di IFN.
B. Partial responder: paziente con riduzione =2 log di HCV-RNA dopo 12 settimane di trattamento antivirale a base di IFN con persistenza di positività di HCV-RNA .
C. Relapser: paziente con HCV-RNA non rilevabile alla fine del trattamento a base di IFN con positività dopo la sospensione
D. HCV genotipo 1 allo screening
4. Esecuzione di Biopsia epatica (eseguita nei 2 anni precedenti) oppure Fibroscan (eseguito entro i 6 mesi precedenti) per individuare i pazienti cirrotici . I pazienti saranno considerati cirrotici quando il risultato della biopsia sarà Metavir score = 4 (o Ishak score = 5) oppure se il risultato del FibroScan > 12.5 kPa
5. Diagnosi radiologica (Rx ed ecografia delle articolazioni interessate) e laboratoristica (VES, CRP, emocromo, glicemia, uricemia, fattore reumatoide, anti fattori perinucleare, anti-peptidi cetrullinati ciclici, anticorpi anti-ANA, anti-ENA, anti-DNA) di artrite infiammatoria sia sieropositiva che sieronegativa
6. Ecografia addominale eseguita nei 6 mesi precedenti la visita basale per escludere epatocarcinoma nei pazienti cirrotici
7. Nel caso si assumano farmaci per l’artrite reumatoide, la dose dei farmaci deve essere stabile da almeno 3 mesi e deve essere mantenuta stabile durante la terapia antivirale.
8. Esami biochimici:
-ALT=10 ULN, bilirubina diretta = 1.5 x ULN, piastrine = 50,000 /mm3
-Emoglobina = 10 g/dL per le femmine, = 11 g/dL per maschi
-Albumina = 3g/dL
-INR = 1.5 x ULN
9. I pazienti non devono aver ricevuto dei farmaci sperimentali nei 30 giorni prima dello screening
10. Acconsentire allo studio firmando il Consenso Informato scritto
11. Contraccezione:
- Soggetti di sesso femminile in età fertile devono utilizzare =1 metodo contraccettivo efficace (=1% tasso di fallimento) durante lo studio e fino a 7 mesi dopo la sospensione della RBV.
- Soggetti di sesso maschile con partner femminile di età fertile devono usare un adeguato metodo contraccettivo durante il trattamento con ribavirina e per 7 mesi dopo la conclusione del trattamento.

I metodi di contraccezione efficaci sono quelli elencati di seguito:
• metodo con doppia barriera, (a) preservativo (maschio o femmina) o (b) diaframma, con spermicida;
•dispositivo intrauterino;
• vasectomia (partner);
• ormonale (ad esempio, pillola contraccettiva, cerotto, impianto intramuscolare o iniezione);
• astinenza, se in linea con lo stile di vita preferito del soggetto ( l'astinenza è definita come astensione da rapporti eterosessuali per tutta la durata della terapia e fino 7 mesi dopo la sospensione).

E.4

Principal exclusion criteria

Patients unable to receive oral therapy
• Patients unable to give written informed consent
• Subjects with clinically-significant illness (other than HCV and seronegative arthritis) or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol
• Pregnant or nursing female or male with pregnant female partner.
• Severe hepatic impairment (Child-Pugh Classification B or C) or decompensated liver cirrhosis
• Active malignancy or previous malignancy in the last five years
• Solid organ transplantation HBV or HIV coinfection (HBsAg and/or anti-HIV positive).
• Creatinine clearance < 30 mL /min (Cockcroft-Gault)
• Active use of Sofosbuvir or ledipasvir prohibited medications
• Any prior exposure to an HCV nonstructural protein (NS)5a-specific inhibitor or any direct acting antiviral drug.
• Contraindications to treatment with RBV:
- A history of severe pre-existing cardiac disease, including unstable or uncontrolled cardiac disease in the previous six months
- Patients with chronic renal failure and / or on hemodialysis.
- Haemoglobinopathies (eg thalassemia, sickle cell anemia
• Administration of any prohibited drug within 28 days preceding the Baseline / Day 1

1. Pazienti non in grado di ricevere terapia per os
2. Soggetti con malattie concomitanti clinicamente significative che a giudizio dello sperimentatore possono interferire con le procedure previste dallo studio
3. Soggetti femmine in stato di gravidanza o in fase di allattamento oppure soggetti maschi con partner in stato di gravidanza
4. Compromissione epatica grave (Classificazione Child-Pugh B o C) o cirrosi scompensata del fegato
5. Malattia neoplastica attiva o pregressa negli ultimi 5 anni
6. Clearance di creatinina < 30 mL /min (Cockcroft-Gault)
7. Assunzione di farmaci con potenziali interazioni con Sofosbuvir/Ledipasvir
8. Esposizione precedente a farmaci inibitori del HCV NS-5 o farmaci antivirali ad azione diretta.
9. Co-infezione dal virus dell’epatite B o HIV (HBsAg e/o anti-HIV positivo)
10. Pazienti con scompenso epatico o storia clinica di precedente scompenso epatico
11. Pazienti con intolleranza ai principi attivi dei farmaci utilizzati nello studio
12. Controindicazioni al trattamento con RBV:
- Un' anamnesi positiva di grave malattia cardiaca pre-esistente, inclusa malattia cardiaca instabile o non controllata nei sei mesi precedenti
- Pazienti con insufficienza renale cronica e/o in emodialisi.
- Emoglobinopatie (ad esempio talassemia, anemia falciforme)
13. Assunzione di qualsiasi farmaco proibito entro 28 giorni precedenti la visita Basale/Giorno 1 come descritto nella sezione 7.3

E.5 End points

E.5.1

Primary end point(s)

The remission / improvement of arthritis at the end of antiviral therapy in patients with CHC genotype 1 (both ever- already-treated for the infection HCV) with or without cirrhosis (CHILD - A) and HIV-positive or HIV-negative chronic arthritis

• La remissione/miglioramento dell’artrite alla fine della terapia antivirale nei pazienti con CHC genotipo 1 (sia mai- sia già-trattati per l’infezione HCV) con o senza cirrosi (CHILD - A) e con artrite cronica sieropositivi o sieronegativi

E.5.1.1

Timepoint(s) of evaluation of this end point

24 weeks.

24 settimane.

E.5.2

Secondary end point(s)

¿ The safety of fixed-dose combination (FDC) SOF / LDV ¿ RBV for 12 weeks in HCV positive patients genotype 1 (both ever- already-treated for the infection HCV) with chronic hepatitis or cirrhosis (CHILD - A ) and chronic arthritis seropositive or seronegative.
¿ The percentage of patients with HCV RNA <LLOQ the 4th and 12th weeks post-treatment (SVR4 and SVR12)
¿ The percentage of subjects with improvement of arthritis during treatment at weeks 4, 8 and 12)
¿ proportion of patients with treatment failure (non-responders)
¿ analysis of HRQOL (quality of life) at baseline, at the end of treatment and at 24 weeks post-treatment. the measurement points will be gathered which relate to the presence / absence of psychiatric symptoms, severity and quality of psychiatric symptoms, where reliability is ensured. Particular attention will be paid to psychiatric and psychological disorders pre-existing and will be recorded at the time of the visit

¿ La sicurezza della combinazione a dose fissa (FDC) SOF/LDV ¿ RBV per 12 settimane nei pazienti HCV- positivi genotipo 1 (sia mai- sia gi¿-trattati per l¿infezione HCV) con epatite cronica o con cirrosi ( CHILD - A ) e con artrite cronica sieropositivi o sieronegativi.
¿ La percentuale di soggetti con HCV RNA <LLOQ alla 4¿ e 12¿ settimane post-trattamento (SVR4 e SVR12)
¿ La percentuale di soggetti con miglioramento di artrite durante il trattamento alle settimane 4, 8 e 12)
¿ percentuale di pazienti con fallimento terapeutico (non-responders)
¿ analisi della HRQOL(qualit¿ della vita) alla visita basale, alla fine della terapia ed alla 24¿ settimana post-trattamento. Saranno raccolti i punteggi delle misurazioni che si riferiscono alla presenza/assenza di sintomi psichiatrici, alla gravit¿ e la qualit¿ dei sintomi psichiatrici, ove si presentassero. Particolare attenzione sar¿ rivolta ai disturbi psichiatrici e psicologici pre-esistenti e saranno registrati al momento della visita.

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

Yes

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)

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

E.8.1.1

Randomised

E.8.1.2

Open

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

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

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.8.5.1

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

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

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.1.1.1

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.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

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)

Usual patient care.

Normale percorso assistenziale.

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

2017-03-29

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-05-16

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

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IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
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