Clinical Trials Register

Summary
EudraCT Number:	2014-000770-19
Sponsor's Protocol Code Number:	D5740C00001
National Competent Authority:	Slovakia - SIDC (Slovak)
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2014-10-27
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

Slovakia - SIDC (Slovak)

A.2

EudraCT number

2014-000770-19

A.3

Full title of the trial

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating
the Safety and Efficacy of Roxadustat for the Treatment of Anemia in
Chronic Kidney Disease Patients not on Dialysis

Multicentrické, randomizované, dvojito zaslepené, placebom kontrolované skúšanie vo fáze 3, ktorého cieľom je zhodnotiť bezpečnosť a účinnosť roxadustatu pri liečbe anémie u nedialyzovaných pacientov s chronickým ochorením obličiek

A.3.1

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

Safety and efficacy study of roxadustat to treat anemia in patients with chronic kidney disease (CKD), not on dialysis.

Zhodnotenie bezpečnosti a účinnosti roxadustatu pri liečbe anémie u nedialyzovaných pacientov s chronickým ochorením obličiek.

A.4.1

Sponsor's protocol code number

D5740C00001

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT02174627

A.5.3

WHO Universal Trial Reference Number (UTRN)

U1111-1154-2636

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	AstraZeneca AB
B.1.3.4	Country	Sweden
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	AstraZeneca AB
B.4.2	Country	Sweden
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	AstraZeneca AB
B.5.2	Functional name of contact point	Information Centre
B.5.3	Address:
B.5.3.1	Street Address	1800 Concord Pike, PO Box 15437
B.5.3.2	Town/ city	Wilminton
B.5.3.3	Post code	19850-5437
B.5.3.4	Country	United States
B.5.6	E-mail	information.centre@astrazeneca.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.3.2	Product code	AZD9941
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	Roxadustat
D.3.9.1	CAS number	808118-40-3
D.3.9.2	Current sponsor code	AZD9941
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	20
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.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.3.2	Product code	AZD9941
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	Roxadustat
D.3.9.1	CAS number	808118-40-3
D.3.9.2	Current sponsor code	AZD9941
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	50
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.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	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.3.2	Product code	AZD9941
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	Roxadustat
D.3.9.1	CAS number	808118-40-3
D.3.9.2	Current sponsor code	AZD9941
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	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	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

Anemia in chronic kidney disease patients without dialysis.

E.1.1.1

Medical condition in easily understood language

Anemia in patients with severe renal disease without dialysis.

E.1.1.2

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

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	10076410
E.1.2	Term	Chronic kidney disease stage 3
E.1.2	System Organ Class	100000004857

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	10076412
E.1.2	Term	Chronic kidney disease stage 5
E.1.2	System Organ Class	100000004857

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	10076411
E.1.2	Term	Chronic kidney disease stage 4
E.1.2	System Organ Class	100000004857

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Primary Efficacy Objective: Evaluate the efficacy of roxadustat compared to placebo for the treatment of anemia in CKD subjects not on dialysis.
Primary Safety Objective: Contribute CV safety data to pooled safety analyses across the phase 3 program

E.2.2

Secondary objectives of the trial

Secondary Efficacy Objectives:
- The efficacy of roxadustat compared to placebo based on Hb response and level during the study
- The efficacy of roxadustat compared to placebo based on Hb response in inflamed subjects
- The effect of roxadustat compared to placebo on Low-density lipoprotein (LDL) cholesterol
- The need for rescue therapy in subjects treated with roxadustat as compared to placebo
- The effect of roxadustat on anemia symptoms and health-related quality of life (HRQoL) based on comparison with placebo
- The effect on the CKD progression of roxadustat as compared to placebo

Secondary Safety Objectives:
- To evaluate the safety and tolerability of roxadustat.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1) Provision of informed consent prior to any study specific procedures
2) Age ≥18 years.
3) A glomerular filtration rate (eGFR) <60 mL/min/1.73 m2,
corresponding to stage 3, 4 or 5 chronic kidney disease (CKD) according
to the Kidney Disease Outcomes Quality Initiative, not receiving dialysis.
4) Mean of 2 most recent central laboratory hemoglobin (Hb) values
during the screening period, obtained at least 7 days apart, must be
<10.0 g/dL.
5) Ferritin ≥50 ng/mL at randomization.
6) Transferrin saturation ≥15% at randomization.
7) Serum folate level ≥ lower limit of normal (LLN) at randomization.
8) Serum vitamin B12 level ≥LLN at randomization.
9) Alanine aminotransferase and aspartate aminotransferase ≤3 x upper
limit of normal (ULN) and total bilirubin ≤1.5 x ULN at randomization.
10) Body weight 45 to 160 kg.

E.4

Principal exclusion criteria

1) Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
2) Previous randomization in the present study
3) Any erythropoietin analogue treatment within 6 weeks of randomization.
4) New York Heart Association Class III or IV congestive heart failure at enrollment
5) Myocardial infarction (MI), acute coronary syndrome, stroke, seizure or a thrombotic/thromboembolic event (e.g., deep vein thrombosis or pulmonary embolism) within 12 weeks prior to randomization 6) History of chronic liver disease (e.g., chronic infectious hepatitis, chronic autoimmune liver disease, cirrhosis or fibrosis of the liver)
7) Known hereditary hematologic disease such as thalassemia, sickle cell anemia, a history of pure red cell aplasia or other known causes for anemia other than CKD.
8) Known and untreated retinal vein occlusion or known and untreated proliferative diabetic retinopathy (risk for retinal vein thrombosis).
9) Diagnosis or suspicion (e.g. complex kidney cyst of Bosniak Category IIF, III or IV) of renal cell carcinoma on renal ultrasound (or other imaging procedure e.g. computerized tomography scan or magnetic resonance imaging conducted at screening or within 12 weeks prior to randomization.
10) Systolic blood pressure (BP) ≥160 mmHg or diastolic BP ≥95 mmHg, within 2 weeks prior to randomization. Patients may be rescreened once BP controlled.
11) History of prostate cancer, breast cancer or any other malignancy, except the following: cancers determined to be cured or in remission for ≥5 years, curatively resected basal cell or squamous cell skin cancers, cervical cancer in situ, or resected colonic polyps.
12) Positive for any of the following: human immunodeficiency virus, hepatitis B surface antigen or anti-hepatitis C virus antibody.
13) Chronic inflammatory diseases such as rheumatoid arthritis, systemic lupus erythematosus, ankylosing spondylitis, psoriatic arthritis or inflammatory bowel disease that is determined to be the principal cause of anemia.
14) Known hemosiderosis, hemochromatosis or hypercoagulable condition
15) Any prior organ transplant or a scheduled organ transplantation date
16) Any red blood cell transfusion (RBC) during the screening period
17) Any current condition leading to active significant blood loss.
18) Any treatment with roxadustat or a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI).
19) Has received another new chemical entity (defined as a compound which has not been approved for marketing) or has participated in any other clinical study that included drug treatment within at least 1 month of the first administration of investigation product in this study. (Note: patients consented and screened, but not randomized in this study or a previous study are not excluded).
20) History of alcohol or drug abuse within 2 years prior to randomization.
21) Females of childbearing potential, unless using contraception as detailed in the protocol or sexual abstinence.
22) Pregnant or breastfeeding females.
23) Known allergy to the investigational product or any of its ingredients.
24) Any medical condition, including active, clinically significant infection, that in the opinion of the investigator or Sponsor may pose a safety risk to a patient in this study, which may confound safety or efficacy assessment or may interfere with study participation.

E.5 End points

E.5.1

Primary end point(s)

Primary Efficacy Endpoint:
US FDA: The primary efficacy endpoint for the US is the mean change from baseline in Hb averaged over week 28 to week 52.
EU health authorities: The primary efficacy endpoint is whether patients achieved Hb response (Yes/No) where Yes is defined as: o Hb ≥ 11.0 g/dL and Hb increase from baseline by ≥ 1.0 g/dL, for subjects with baseline Hb > 8.0 g/dL;
or
o Hb increase from baseline by ≥ 2.0 g/dL, for subjects with baseline Hb ≤ 8.0 g/dL at two consecutive visits [dates] (with available data) separated at least 5 days during the first 24 weeks of treatment without having received rescue therapy (RBC transfusion, ESA, or IV iron) prior to Hb response.
Primary Safety Endpoint:
Adjudicated CV safety data. Analyses of the adjudicated events are described in a separate pooled statistical analysis plan.

E.5.1.1

Timepoint(s) of evaluation of this end point

Primary Efficacy Endpoint:
US FDA: From week 28 to week 52.
EU health authorities: From week 0 to week 24.

Primary Safety Endpoint:
Analyses of the adjudicated events are described in a separate pooled statistical analysis plan.

E.5.2

Secondary end point(s)

Secondary Efficacy Endpoints:
1) Hb response as noted for EU Primary Endpoint.
2) Mean change in Hb from baseline to the subjects mean level between week 28 to week 52 in subjects with baseline high-sensitivity C-reactive protein (hsCRP) greater than the Upper Limit Normal (ULN)
3) Proportion of total time of Hb ≥ 10 g/dL from week 28 to week 52.
4) Proportion of total time of Hb within the interval of 10-12 g/dL from week 28 to week 52
5) Mean change in LDL cholesterol from baseline to week 24
6) Time-to-first (and proportion of subjects receiving) instance of receiving intravenous (IV) iron, red blood cell (RBC) transfusions, or erythropoietin analogue as rescue therapy.
7) Time-to-first (and proportion of subjects receiving) instance of receiving red blood cell (RBC) transfusions as rescue therapy.
8) Change from baseline in SF-36 Vitality (VT) sub-score
9) Annual rate of eGFR change in log scale, calculated as the linear slope of log (eGFR values) to prior to initiation of dialysis/kidney transplant
10) Change from baseline in SF-36 Physical Functioning (PF) sub-score
Secondary Safety Endpoints:
Adverse events (AEs), serious adverse events (SAEs).
Changes in vital signs, electrocardiogram (ECG) and laboratory values.

E.5.2.1

Timepoint(s) of evaluation of this end point

Efficacy Endpoints
1) From randomization to week 24
2) From week 28 to week 52
3) From week 28 to week 52
4) From week 28 to week 52
5) From randomization to week 24
6) From the first date of study drug (SD) intake to EOS for subjects without SD discontinuation (SDD) or to the last date plus 28 days of SD intake for SDD subjects.
7) From the first date of study drug (SD) intake to EOS for subjects without SD discontinuation (SDD) or to the last date plus 28 days of SD intake for SDD subjects.
8) From week 12 to week 28
9) From randomization to EOS for subjects without initiation of
Dialysis/Transplant (ID/T) or to the date of ID/T for subjects having these renal events.
10) From week 12 to week 28
Safety Endpoints:
From date of first dose of SD to 28 days after last dose of SD

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

Yes

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

Evaluate self-reported health status.
Evaluate the need for rescue therapy.

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

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

Argentina

Brazil

Bulgaria

Canada

Czech Republic

Germany

Hungary

India

Italy

Korea, Republic of

Mexico

Peru

Philippines

Poland

Romania

Russian Federation

Slovakia

Spain

Taiwan

Thailand

Turkey

Ukraine

United Kingdom

United States

Vietnam

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:

1300

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

1300

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

460

F.4.2.2

In the whole clinical trial

2600

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)

None

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

2014-12-10

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2014-11-18

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2018-10-04

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IMP with orphan designation in the indication
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