Clinical Trials Register

Summary
EudraCT Number:	2016-001979-70
Sponsor's Protocol Code Number:	IVA_01_337_HNAS_16_002
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2016-10-26
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

Spain - AEMPS

A.2

EudraCT number

2016-001979-70

A.3

Full title of the trial

A randomized, double-blind, placebo-controlled, multicenter, dose-range, proof-of-concept, 24-week treatment study of IVA337 in adult subjects with nonalcoholic steatohepatitis (NASH)

Estudio aleatorizado, doble ciego, controlado con placebo,
multicéntrico, de rango de dosis, de prueba de concepto y de 24
semanas de tratamiento con IVA337 en pacientes adultos con
esteatohepatitis no alcohólica (EHNA).

A.3.1

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

A randomized, double-blind, placebo-controlled, multicenter, dose-range, proof-of-concept, 24-week treatment study of IVA337 in adult subjects with nonalcoholic steatohepatitis (NASH)

A.4.1

Sponsor's protocol code number

IVA_01_337_HNAS_16_002

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	Inventiva S.A.
B.1.3.4	Country	France
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	Inventiva S.A.
B.4.2	Country	France
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	INVENTIVA S.A.
B.5.2	Functional name of contact point	Project Manager, ABELLO Nicolas
B.5.3	Address:
B.5.3.1	Street Address	50, Rue de Dijon
B.5.3.2	Town/ city	Daix
B.5.3.3	Post code	21121
B.5.3.4	Country	France
B.5.4	Telephone number	+330380 447 593
B.5.5	Fax number	+330380 447 561
B.5.6	E-mail	nicolas.abello@inventivapharma.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	IVA337
D.3.2	Product code	IVA337
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	Not Available
D.3.9.1	CAS number	927961-18-0
D.3.9.2	Current sponsor code	IVA337
D.3.9.3	Other descriptive name	1-(6-BENZOTHIAZOLYLSULFONYL)-5-CHLORO-1H-INDOLE-2-BUTANOIC ACID
D.3.9.4	EV Substance Code	SUB176833
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.3.11 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
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.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Nonalcoholic steatohepatitis (NASH)

esteatohepatitis no alcohólica (EHNA).

E.1.1.1

Medical condition in easily understood language

Nonalcoholic steatohepatitis (NASH)

esteatohepatitis no alcohólica (EHNA).

E.1.1.2

Therapeutic area

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

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	19.0
E.1.2	Level	PT
E.1.2	Classification code	10053219
E.1.2	Term	Non-alcoholic steatohepatitis
E.1.2	System Organ Class	10019805 - Hepatobiliary 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

To assess the safety and the efficacy on the activity part of the Steatosis Activity Fibrosis histological score (inflammation and ballooning) of a 24-week treatment with two doses of IVA337 (800, 1200 mg/24h) in NASH adult patients.

Evaluar la seguridad y la eficacia en la parte de actividad de la puntuación histológica de la esteatosis, la actividad y la fibrosis (Steatosis Activity Fibrosis, SAF) (inflamación y abombamiento) de un tratamiento de 24 semanas con dos dosis de IVA337 (800, 1200 mg/24 h) en pacientes adultos con EHNA.

E.2.2

Secondary objectives of the trial

Pharmacokinetics.

Farmacocinética.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

-Adult subjects, age ≥18 years.
-NASH histological diagnosis according to the currently accepted definition of both EASL and AASLD (1–3), requiring the combined presence of steatosis (any degree ≥ 5%) + lobular inflammation of any degree + liver cell ballooning of any amount, on a liver biopsy performed ≤ 6 months before screening in the study and confirmed by central reading during the screening period and
a.SAF Activity score of 3 or 4 (>2)
b.SAF Steatosis score ≥ 1
c.SAF Fibrosis score: < 4
-Subject agrees to have a liver biopsy performed after 24 weeks of treatment
-Compensated liver disease with the following hematologic and biochemical criteria on entry into protocol:
oALT < 10N
oHemoglobin > 11 g/dL for females and > 12 g/dL for males
oWhite blood cell (WBC) > 2.5 K/µL
oNeutrophil count > 1.5 K/µL
oPlatelets > 100 K/µL
oTotal bilirubin < 35µmol/L. Patients with bilirubin > 35µmol/L can be included if non-conjugated bilirubin in the setting of a Gilbert syndrome.
oAlbumin > 36 g/L
oTP > 80% or INR > 1.4
oSerum creatinin <1.3 mg/dL (men) or <1.1 (women) or estimated glomerular filtration rate ≥ 60 mL/min/1.73m2
-No other cause of chronic liver disease (autoimmune, primary biliary cholangitis, HBV, HCV, Wilson’s, α-1-antitrypsin deficiency, hemochromatosis etc…)
-If applicable, have a stable type 2 diabetes, defined as HgbA1c < 8.5% and fasting glycemia <10 mmol/L, no changes in medication in the previous 6 months, and no new symptoms associated with decompensated diabetes in the previous 3 months.
-Have a stable weight since the liver biopsy was performed defined by no more than a 5 % loss of initial body weight
-Negative pregnancy test or post-menopausal. Women with childbearing potential (i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile) must be using a highly effective method of contraception (i.e. combined (estrogen and progestogen containing) hormonal/ progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomised partner, sexual abstinence).
-Subjects must be willing to give written informed consent.

1. Pacientes adultos, de ≥18 años de edad.
2. Diagnóstico histológico de EHNA según la definición actualmente aceptada de la EASL y AASLD, que precisa la presencia combinada de esteatosis (cualquier grado ≥ 5 %) + inflamación lobular de cualquier grado + abombamiento de las células hepáticas de cualquier magnitud, en una biopsia hepática realizada ≤ 6 meses antes de la selección en el estudio y confirmada mediante lectura central durante el periodo de selección y
a. puntuación de la actividad en SAF de 3 o 4(> 2)
b. puntuación de la esteatosis en SAF ≥ 1
c. puntuación de la fibrosis en SAF < 4
3. El paciente acepta que se le realice una biopsia hepática después de 24 semanas de tratamiento.
4. Enfermedad hepática compensada con los siguientes criterios hematológicos y bioquímicos en el momento de entrar en el protocolo:
o ALT < 10 veces el LSN
o Hemoglobina > 11 g/dl para mujeres y > 12 g/dl para hombres
o Leucocitos (LEU) > 2,5 K/μl
o Recuento de neutrófilos > 1,5 K/μl
o Plaquetas > 100 K/μl
o Bilirrubina total < 35 μmol/l. Los pacientes con bilirrubina > 35 μmol/l pueden ser incluidos si se trata de bilirrubina no conjugada en un escenario de síndrome de Gilbert.
o Albúmina > 36 g/l
o TP > 80 % o INR < 1,4
o Creatinina sérica < 1,3 mg/dl (hombres) o < 1,1 mg/dl (mujeres) o índice de filtración glomerular estimado < 60 ml/min/1,73 m2
5. Ninguna otra causa de enfermedad hepática crónica (autoinmune, colangitis biliar primaria, VHB, VHC, enfermedad de Wilson, déficit de α-1-antitripsina, hemocromatosis, etc…).
6. Si procede, tener diabetes de tipo 2 estable, definida como HgbA1c < 8,5 % y glucemia en ayunas < 10 mmol/l, sin cambios en la medicación en los 6 meses previos, y sin nuevos síntomas asociados auna descompensación diabética en los 3 meses previos.
7. Tener un peso estable desde que se realizó la biopsia hepática, definido por una pérdida de peso no superior al 5 % del peso corporal inicial.
8. Prueba de embarazo negativa o posmenopausia. Las mujeres potencialmente en edad fértil (es decir fértil, después de la menarquia y hasta llegar a la etapa posmenstrual a no ser que exista un estado de esterilidad permanente) deben usar un método anticonceptivo altamente eficaz (es decir hormona combinada (que contiene estrógeno y progesterona) /anticoncepción hormonal de progesterona solo asociado con la inhibición de la ovulación, dispositivo intrauterino, el sistema intrauterino liberador de hormonas, la oclusión tubárica bilateral, vasectomía de su pareja, abstinencia sexual).
9. Los pacientes deben estar dispuestos a dar su consentimiento informado por escrito.

E.4

Principal exclusion criteria

-Evidence of another form of liver disease.
-History of sustained excess alcohol ingestion: daily alcohol consumption > 30 g/day (3 drinks per day) for males and > 20 g/day (2 drinks/day) for females.
-Unstable metabolic condition: Weight change > 5kg in the last three months, diabetes with poor glycemic control (HgbA1c > 8.5%), introduction of an antidiabetic or of an anti-obesity drug/malabsorptive or restrictive bariatric (weight loss) surgery in the past 6 months prior to screening.
-History of gastrointestinal malabsorptive bariatric surgery within less than 5 years or ingestion of drugs known to produce hepatic steatosis including corticosteroids, high-dose estrogens, methotrexate, tetracycline or amiodarone in the previous 6 months.
-Significant systemic or major illnesses other than liver disease, including congestive heart failure (class C and D of the AHA), unstable coronary artery disease, cerebrovascular disease, pulmonary disease, renal failure, organ transplantation, serious psychiatric disease, malignancy that, in the opinion of the investigator, would preclude treatment with IVA337 and/or adequate follow up.
-HB antigen >0, HCV PCR >0 (patients with a history of HCV infection can be included if HCV PCR is negative since more than 3 years), HIV infection.
-Pregnancy/lactation or inability to adhere to adequate contraception in women of child-bearing potential.
-Active malignancy except cutaneous basocellular carcinoma.
-Any other condition which, in the opinion of the investigator would impede competence or compliance or possibly hinder completion of the study
-Body mass index (BMI) >45 kg/m2.
-Type 1 diabetes.
-Diabetic ketoacidosis
-Fasting Triglycerides > 300 mg/dL.
-Hemostasis disorders or current treatment with anticoagulants.
-Contra-indication to liver biopsy.
-History of, or current cardiac dysrhythmias and / or a history of cardiovascular disease, including myocardial infarction, except patients with only well controlled hypertension.
-Participation in any other investigational drug study within the previous 3 months.
-Have a known hypersensitivity to any of the ingredients or excipients of the IMP.
-Be possibly dependent on the Investigator or the Sponsor (eg, including, but not limited to, affiliated employee).

1. Evidencia de otra forma de enfermedad hepática.
2. Antecedentes de consumo de alcohol excesivo sostenido: consumo diario de alcohol > 30 g/día (3 consumiciones al día) para hombres y > 20 g/día (2 consumiciones al día) para mujeres.
3. Afección metabólica inestable: cambio de peso > 5 kg en los últimos tres meses, diabetes con un control glucémico deficiente (HgbA1c > 8,5 %), introducción de un antidiabético o de un fármaco contra la obesidad/cirugía bariátrica malabsortiva o restrictiva (pérdida de
peso) en los 6 meses previos a la selección.
4. Antecedente de cirugía bariátrica malabsortiva gastrointestinal menos de 5 años antes o toma de fármacos que producen esteatosis hepática, incluidos corticosteroides, estrógenos en dosis altas, metotrexato, tetraciclina o amiodarona en los 6 meses previos.
5. Enfermedades importantes o sistémicas significativas distintas de enfermedad hepática, incluyendo insuficiencia cardíaca congestiva (clase C y D de la Asociación Americana del Corazón [American Heart Association, AHA]), arteriopatía coronaria inestable,enfermedad cerebrovascular, enfermedad pulmonar, insuficiencia renal, trasplante de órgano, enfermedad psiquiátrica grave, neoplasia maligna que, en opinión del investigador, impediría el tratamiento con IVA337 y/o un seguimiento adecuado.
6. Antígeno HB > 0, RCP del VHC > 0 (los pacientes con antecedentes de infección por VHC pueden ser incluidos si la RCP del VHC es negativa desde hace más de 3 años), infección por VIH.
7. Embarazo/lactancia o incapacidad para cumplir los requisitos anticonceptivos adecuados en mujeres en edad fértil.
8. Neoplasia maligna activa, excepto carcinoma basocelular cutáneo.
9. Cualquier otra afección que, en opinión del investigador, afectaría a la capacidad o el cumplimiento, o que posiblemente impediría completar el estudio.
10. Índice de masa corporal (IMC) > 45 kg/m2.
11. Diabetes tipo 1.
12. Cetoacidosis diabética
13. Triglicéridos en ayunas > 300 mg/dl.
14. Trastornos de la hemostasia o tratamiento actual con anticoagulantes.
15. Contraindicación de la biopsia hepática.
16. Disritmias cardíacas previas o actuales y/o antecedentes de acontecimiento de enfermedad cardiovascular, incluido infarto de miocardio, excepto en pacientes con solo hipertensión bien controlada.
17. Participación en cualquier otro estudio clínico dentro de los 3 meses previos.
18. Tener una hipersensibilidad conocida a cualquiera de los ingredientes o excipientes del producto en fase de investigación clínica
19. Ser posiblemente dependiente del investigador o del promotor (p. ej., incluidos, entre otros, ser empleados de filiales).

E.5 End points

E.5.1

Primary end point(s)

The primary endpoint is a binary outcome (responder / non responder). A responder is defined as a decrease from baseline to week 24 of at least 2 points of the SAF activity score combining hepatocellular inflammatory and ballooning score without fibrosis progression. Responder rates will be compared between the placebo and IMP groups at the end of the treatment period (week 24) using a Cochran Mantel Haenzel test stratified on diabetes.

El criterio de valoración principal es un resultado binario
(con respuesta/sin respuesta). Un paciente con respuesta se define como una reducción desde el inicio hasta la semana 24 de al menos 2 puntos en la puntuación de la actividad de SAF, que combina la puntuación de abombamiento e inflamación hepatocelular sin
progresión de la fibrosis. Las tasas de pacientes con respuesta se compararán entre los grupos de placebo y del PEI al final del periodo de tratamiento (semana 24) utilizando una prueba de Cochran Mantel Haenzel estratificada según la diabetes.

E.5.1.1

Timepoint(s) of evaluation of this end point

At the end of the treatment period (week 24)

Al final del periodo de tratamiento (semana 24).

E.5.2

Secondary end point(s)

The following changes from baseline to 24 weeks of treatment will be evaluated:
•NASH improvers defined as subjects with a decrease of at least 2 points in NAS, and no worsening in fibrosis in NASH from baseline to end of treatment (week 24).
•Percent of patients with reversal of NASH (Steatosis without ballooning and with or without mild inflammation and no worsening of fibrosis) from baseline to end of treatment (week 24).
•Percent of patients with a change in components of SAF score from baseline to end of treatment (week 24):
-Steatosis: -1 point
-Lobular inflammation: -1 point
-Balloonning: -1 point
•Immunohistochemistry: change in the semiquantitative score of ballooning and stellate cell activation from baseline to end of treatment (week 24).
•Change in fibrosis score on a 4-point scale (SAF) and modified Ishak: - 1 point from baseline to end of treatment (week 24). Comparison of mean change in fibrosis area assessed by morphometry (CPA) from baseline to end of treatment (week 24).
•Liver enzymes (ALT, AST, γGT) change from baseline to end of treatment (week 24).
•Inflammatory markers (fibrinogen, hs-CRP, alpha2 macroglobulin and haptoglobin levels) change from baseline to end of treatment (week 24).
•Glucose metabolism (fasting glucose and insulin, HOMA index and, in subjects with T2DM, HbA1c) change from baseline to end of treatment (week 24).
•Main plasma lipids levels (TC, HDL-C, calculated LDL-C, TG and apoA1) change from baseline to end of treatment (week 24).
•Adiponectin change from baseline to end of treatment (week 24).

Se evaluarán los siguientes cambios desde el inicio
hasta las 24 semanas de tratamiento:
· Pacientes con mejoría en la EHNA, definida como sujetos con una disminución de al menos 2 puntos en la puntuación NAS, y ausencia de empeoramiento de la fibrosis desde el inicio hasta el final del tratamiento (semana 24).
· Porcentaje de pacientes con inversión de la EHNA (esteatosis sin abombamiento y con o sin inflamación leve y ausencia de empeoramiento de la fibrosis) desde el inicio hasta el final del tratamiento (semana 24).
· Porcentaje de pacientes con un cambio en los componentes de la puntuación SAF desde el inicio hasta el final de tratamiento (semana 24):
- Esteatosis: -1 punto
- Inflamación lobular: -1 punto
- Abombamiento: -1 punto
· Inmunohistoquímica: cambio en la puntuación semicuantitativa de abombamiento y activación de células estrelladas desde el inicio hasta el final del tratamiento (semana 24).
· Cambio en la puntuación de la fibrosis en una escala de 4 puntos (SAF) e Ishak modificado: - 1 punto desde el inicio hasta el final del tratamiento (semana 24). Comparación del cambio medio en el área de la fibrosis evaluada mediante morfometría (área proporcional de colágeno [collagen proportionate area, CPA])
desde el inicio hasta el final del tratamiento (semana 24).
· Cambio en las enzimas hepáticas (ALT, AST, γGT) desde el inicio hasta el final del tratamiento (semana 24).
· Cambio en los marcadores inflamatorios (niveles de fibrinógeno, PCR-as, macroglobulina alfa 2 y haptoglobina) desde el inicio hasta el final del tratamiento (semana 24).
· Cambio en el metabolismo de la glucosa (glucosa en ayunas e insulina, índice HOMA y, en pacientes con DMT2, HbA1c) desde el inicio hasta el final del tratamiento (semana 24).
· Cambio en los principales niveles de los lípidos plasmáticos (CT, C-HDL, C-LDL calculado, TG y apoA1) desde el inicio hasta el final del tratamiento (semana 24).
· Cambio en la adiponectina desde el inicio hasta el final del tratamiento (semana 24).

E.5.2.1

Timepoint(s) of evaluation of this end point

From baseline to 24 weeks of treatment

desde el inicio hasta las 24 semanas de tratamiento

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

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)

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

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

Australia

Austria

Belgium

Czech Republic

France

Germany

Italy

Netherlands

Poland

Portugal

Spain

Switzerland

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

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:

270

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

230

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)

There are currently no drug therapies specifically approved for the treatment of NASH. The patient will be taken care off by the investigator who will decide, according to each patient, the need to use the lifestyle changes recommendations whenever appropriate and treatment of comorbidities which may play a role in NASH such as, for example, diabetes and hyperlipidemia.

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

2016-12-23

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2016-12-19

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2020-03-16

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IMP with orphan designation in the indication
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