Clinical Trials Register

Summary
EudraCT Number:	2013-003714-40
Sponsor's Protocol Code Number:	HCQinpediatricILD
National Competent Authority:	Austria - BASG
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2018-08-10
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

Austria - BASG

A.2

EudraCT number

2013-003714-40

A.3

Full title of the trial

Hydroxychloroquine in pediatric ILD START randomized controlled in parallel-group, then switch placebo to active drug, and STOP randomized controlled in parallel-group to evaluate the efficacy and safety of hydroxychloroquine (HCQ)

Hydroxychloroquin bei pädiatrischer interstitieller Lungenerkrankung (ILD) START randomisiert kontrolliert in Parallelgruppe, dann Wechsel von Placebo zum aktiven Medikament und STOP randomisiert kontrolliert in Parallelgruppe, um die Wirksamkeit und Sicherheit von Hydroxychloroquin (HCQ) zu ermitteln.

A.3.1

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

HCQ in pediatric ILD

A.3.2

Name or abbreviated title of the trial where available

HCQ in pediatric ILD

A.4.1

Sponsor's protocol code number

HCQinpediatricILD

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT02615938

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	Klinikum der Ludwig-Maximilian-Universität München
B.1.3.4	Country	Germany
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	EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR RESEARCH & INNOVATION
B.4.2	Country	European Union
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Klinikum der Ludwig-Maximilian-Universität München
B.5.2	Functional name of contact point	Matthias Griese
B.5.3	Address:
B.5.3.1	Street Address	Lindwurmstr. 4
B.5.3.2	Town/ city	München
B.5.3.3	Post code	80337
B.5.3.4	Country	Germany
B.5.4	Telephone number	4989440057871
B.5.5	Fax number	4989440057872
B.5.6	E-mail	Matthias.griese@med.uni-muenchen.de

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	hydroxychloroquine
D.3.4	Pharmaceutical form	Capsule
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	HYDROXYCHLOROQUINE
D.3.9.1	CAS number	118-42-3
D.3.9.4	EV Substance Code	SUB08077MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/kg milligram(s)/kilogram
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	6.5
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.3.1	Product name	hydroxychloroquine
D.3.4	Pharmaceutical form	Capsule
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	HYDROXYCHLOROQUINE
D.3.9.1	CAS number	118-42-3
D.3.9.4	EV Substance Code	SUB08077MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/kg milligram(s)/kilogram
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	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	Capsule
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Capsule, hard
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

interstitial lung disease

Interstitielle Lungenerkrankung

E.1.1.1

Medical condition in easily understood language

interstititial lung disease

E.1.1.2

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	PT
E.1.2	Classification code	10022611
E.1.2	Term	Interstitial lung disease
E.1.2	System Organ Class	10038738 - Respiratory, thoracic and mediastinal disorders

E.1.3

Condition being studied is a rare disease

Yes

E.2 Objective of the trial

E.2.1

Main objective of the trial

START HCQ block
To evaluate the efficacy of HCQ after 28 days of treatment in chILD compared to placebo.

STOP HCQ block
To evaluate the efficacy of HCQ after 84 days of treatment in chILD compared to Placebo

START HCQ Block
Bewertung der Wirksamkeit von HCQ nach 28 Behandlungstagen, verglichen mit Placebo, in Kindern mit Interstitieller Lungenerkrankung.

STOP HCQ Block
Bewertung der Wirksamkeit von HCQ nach 84 Behandlungstagen, verglichen mit Placebo, in Kindern mit Interstitieller Lungenerkrankung.

E.2.2

Secondary objectives of the trial

START HCQ block
- To evaluate the efficacy of HCQ after 56 days of treatment in chILD compared to 28 days.
- To evaluate the safety of HCQ after 28 and 56 days of treatment in chILD.
- To evaluate blood levels of HCQ after 28 and 56 days of treatment in chILD.

STOP HCQ block
- To evaluate the efficacy of chronic (> 3 months) HCQ treatment in chILD compared to placebo.
- To evaluate the safety of HCQ after > 3 months of treatment in chILD.
- To evaluate blood levels of HCQ before and after treatment in chILD

START HCQ Block
- Bewertung der Wirksamkeit von HCQ nach 56 Behandlungstagen verglichen mit 28 Behandlungstagen in Kindern mit Interstitieller Lungenerkrankung.
- Bewertung der Sicherheit von HCQ nach 28 Behandlungstagen verglichen mit 56 Behandlungstagen in Kindern mit Interstitieller Lungenerkrankung.
- Bewertung der Blutwerte von HCQ nach 28 Behandlungstagen verglichen mit 56 Behandlungstagen in Kindern mit Interstitieller Lungenerkrankung.

STOP HCQ Block
- Beurteilung der Wirksamkeit von HCQ Dauertherapie (> 3 Monate) verglichen mit Placebo, in Kindern mit Interstitieller Lungenerkrankung.
- Beurteilung der Sicherheit von HCQ nach einer Dauertherapie (> 3 Monate) in Kindern mit Interstitieller Lungenerkrankung.
- Beuurteilung der Blutwerte von HCQ vor und nach Behandlung in Kindern mit Interstitieller Lungenerkrankung.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1)Patients should be clinically stable during baseline (between Visit 1 and 2) for inclusion into the study
a) To determine this, attending physicians can use SpO2 in room air for patients on room air or on O2-supplement; the absolute difference on SpO2 is expected not to be ≥ 5% between Visit 1 and 2. For patients on respiratory support, the summary key parameters should not change ≥ 20% between Visit 1 and 2
and
b) No major changes in other medications between Visit 1 and 2
2)Mature newborn ≥ 37 weeks of gestation, age ≥ 3 wks and < 2y
or
Infants and children (≥ 2 y and < 18 y)
or
Adults (≥18 and ≤30 y)
or
Previously preterm (≤ 37 weeks of gestation) babies or children and adults of all ages if chILD genetically diagnosed (see inclusion criterion 3.)
3) Diagnosis of chronic (≥ 3 wks of duration) diffuse parenchymal lung disease (DPLD = chILD), defined in at least one of the following ways:
a) chILD genetically diagnosed
Surfactant dysfunction disorders including patients with mutations in SFTPC, SFTPB, ABCA3, TTF1 (Nkx2-1), further extremely rare entities with specific mutations, for example in TBX4, NPC2, NPC1, NPB, COPA, LRBA and other genes. In this case, also previously preterm (≤ 37 weeks of gestation) babies or children and adults of all ages can be included into the study.
b) chILD histologically diagnosed
• Chronic pneumonitis of infancy (CPI)
• Desquamative interstitial pneumonia (DIP)
• Lipoid pneumonitis / Cholesterol pneumonia
• Nonspecific interstitial pneumonia (NSIP)
• PAP after the exclusion of mutations in GMCSF-Ra/b and GMCSF autoantibodies*
• Usual interstitial pneumonia (UIP)
• Follicular bronchitis/ bronchiolitis/ Lymphogenic interstitial pneumonia (LIP)
• Storage disease with primary pulmonary involvement (e.g. Nieman Pick)
• Hermansky Pudlak Syndrome
• Idiopathic pulmonary haemorrhage (haemosiderosis)*
• Other histology diagnosing chILD, in particular combination of the above pattern, but not exclusively
4) Start block: no HCQ treatment in the last 12 weeks
Stop block: stable HCQ treatment for at least the last 12 weeks
5) Ability of subject or/and legal representatives to understand character and individual consequences of clinical trial.
6) Signed and dated informed consent of the subject (if the subject has the ability) and the representatives (of underaged children) must be available before start of any specific trial procedures.

(1) Patienten sollten während der Basislinie (zwischen Visiten 1 und 2) für die Aufnahme in die Studie klinisch stabil sein.

(a) um dies festzustellen, können behandelnde Ärzte die SpO2 (pulsoxymetrisch gemessene Sauerstoffsättigung) für Patienten auf Raumluft oder Patienten mit O2-Ergänzung messen; die absolute Differenz der gemessenen SpO2 Werte sollte nicht ≥ 5% zwischen den Visiten 1 und 2 liegen. Bei Patienten, die Sauerstoffunterstützung erhalten sollte die Differenz nicht ≥ 20 % zwischen den Visiten 1 und 2 betragen
und
(b) keine wesentlichen Änderungen in anderen Medikamenten zwischen Visten 1 und 2

(2) Reife Neugeborene ≥ 37 Gestationswoche, Alter ≥ 3 Wochen und < 2 Jahren
oder
Säuglinge und Kinder (≥ 2 Jahren und < 18 Jahren)
oder
Erwachsene (≥18 und ≤30 Jahren)
oder
Einst frühgeborene (≤ 37 Schwangerschaftswoche) Babys oder Kinder und Erwachsene jeden Alters, wenn Interstitielle Lungenerkrankung genetisch diagnostiziert wurde (siehe Aufnahme Kriterium 3.)

(3) die Diagnose der chronischen (≥ 3 Wochen Dauer) diffusen Lungenparenchymerkrankung (englisch: Diffuse Parenchymal Lung Disease (DPLD)) (auch bekannt als Interstitielle Lungenerkrankung (englisch: Interstitial Lung Disease (ILD)) (ILD in Kindern auf Englisch abgekürzt chILD) definiert auf zumindestens einer der folgenden Arten:
(a) chILD genetisch diagnostiziert
Surfactant-Dysfunktionserkrankungen einschließlich Patienten mit Mutationen in SFTPC, SFTPB, ABCA3, TTF1 (Nkx2-1), weitere extrem seltene Entitäten mit spezifischen Mutationen, zum Beispiel in TBX4, NPC2, NPC1, NPB, COPA, LRBA und anderen Gene. In diesem Fall können auch zuvor (≤ 37 Schwangerschaftswoche) frühgeborenen Babys oder Kinder und Erwachsene aller Altersgruppen in die Studie einbezogen werden.
(b) chILD histologisch diagnostiziert
• Chronische Pneumonitis der Kindheit (engl. CPI)
• Desquamative interstitielle Pneumonie (engl. DIP)
• Lipoide Pneumonie / Cholesterol Pneumonie
• Nicht-spezifische interstitielle Pneumonie (engl. NSIP)
• PAP nach dem Ausschluss von Mutationen in GMCSF-Ra/b und GMCSF Autoantikörpern
• Gewöhnliche interstitielle Pneumonie (engl. UIP)
• Follikuläre Bronchitis / Bronchiolitis / Lymphogenic interstitielle Pneumonie (LIP)
• Speicherkrankheit mit primärer Lungenbeteiligung (z.B. Niemann-Pick-Krankheit)
• Hermansky-Pudlak-Syndrom
• Idiopathische pulmonale Blutung (Haemosiderosis)
• Andere Histologie Diagnosen von chILD, im besonderen Kombinationn der oben genannten Muster, aber nicht ausschließlich.

(4) Start-Block: keine HCQ Behandlung in den letzten 12 Wochen
Stop-Block: stabile HCQ Behandlung seit mindestens 12 Wochen

(5) die Fähigkeit des Subjekts oder/und des gesetzlichen Vertreters, den Charakter und die individuellen Folgen der klinischen Prüfung zu verstehen.

(6) eine signierte und datierte Einwilligungserklärung der Person (wenn die Person die Möglichkeit hat) und des Vertreters (minderjährige Kinder) müssen vor Beginn der studienspezifischen Maßnahmen vorliegen.

E.4

Principal exclusion criteria

Subjects presenting with any of the following criteria will not be included in the trial:
- chILD primarily related to developmental disorders
- chILD primarily related to growth abnormalities reflecting deficient alveolarisation
- hILD related to chronic aspiration
- chILD related to immunodeficiency
- chILD related to abnormalities in lung vessel structure
- chILD related to organ transplantation/organ rejection/GvHD
- chILD related to recurrent infections
- Acute severe infectious exacerbations
- Known hypersensitivity to HCQ, or other ingredients of the capsules (lactose-monohydrate, povidone, maize starch, magnesium stearate, hypromellose, macrogol or titanium dioxide (E 171), silicon dioxide or mannitol), to sucrose-octaacetate or sodium saccharine.
- Proven retinopathy or maculopathy
- Glucose-6-phosphate-dehydrogenase deficiency resulting in favism or hemolytic anemia
- Myasthenia gravis
- Hematopoetic disorders
- Pregnancy and lactation (Women with childbearing potential have to practice a medically accepted contraception during trial and till three months after the end of the treatment with HCQ, and a negative pregnancy test (serum or urine) should be existent on Visit 1, if girls of childbearing age and only if sexual relations are known or probable. It is at the discretion and responsibility of the attending physician to decide, whether a pregnancy test is necessary or not. Reliable contraception are systematic contraceptives (oral, implant, injection). Women that are sterile by surgery can participate in the trial. At the discretion of the investigator, sexual abstinence is also accepted as contraceptive method. Girls after menarche have to receive a counselling about birth control methods in presence of at least one parent, which has to be documented in the patient notes.
- Participation in other clinical trials during the present clinical trial or not beyond the time of 4 half-lives of the medication used, at least one week.
- Hereditary galactose intolerance, lactase deficiency or glucose-galactose-malabsorption
- Renal insufficiency at screening, defined as glomerular filtration rate (GFR)
o < 40 mL/min/1.73 m2 in patients age 3 to 8 weeks
o < 60 mL/min/1.73 m2 in patients ≥ 8 weeks of Age (KDIGO guideline 2012, K/DOQI guideline 2002)
- Liver disease, gastrointestinal disorder, haematological disorder, epilepsy or other neurological disorder, psoriasis, porphyria at the discretion of the treating physician
- Simultaneous prescription of other potentially nephrotoxic or hepatotoxic medication at the discretion of the treating physician

E.5 End points

E.5.1

Primary end point(s)

START HCQ block
Relative change trial day 1 (i.e. Visit 2) through day 28 (i.e. Visit 3) and relative change day 28 to day 56, (i.e. Visit 4): change active compound compared to change placebo

STOP HCQ block
Relative change trial day 1 (i.e. Visit 2) through day 84 (i.e. Visit 5): change active compound compared to change placebo

E.5.1.1

Timepoint(s) of evaluation of this end point

28/56 / 84 days

E.5.2

Secondary end point(s)

- For both, START and STOP HCQ blocks absolute and relative change under the active compound from trial day 1 (i.e. Visit 2), to START block: day 28 (i.e. Visit 3), STOP block: day 84 (i.e. Visit 5) each, will be compared to change under placebo. The following variables will be investigated:

- Oxygen saturation (O2-sat, in room air) (only absolute, as relative already primary outcome)
- Respiratory rate (RR, in room air) (relative and absolute)

- Retractions (yes/no)
- Coughing (yes/no)
- Oxygen demand

- pO2, pCO2 (capillary, in room air)
- Chest x-ray
- Quality-of-life
- Health economics
- Overall survival
- Weight for height
- Cumulative amounts of steroid equivalents. Clinical course of lung disease (since last visit): Healthy/ Sick-better/ Sick-same/ Sick-worse/ Patient died
- Pulmonary exacerbation (since last visit)
If > 5y old (If a child ≤ 5 years is already able to perform the listed investigations (spirometry or bodyplethysmography), these should also be performed and documented at the discretion of the investigator.)
The following lung function parameters will be assessed:
FEV1 % predicted (recorded in L), FEV 1 (L), FVC % predicted (recorded in L), FVC (L); MEF 75 (L/s); MEF 50 (L/s); MEF 25 (L/s); TLC (L); ITGV (L); RV (L); R eff (kPa*s/L); R eff predicted (%).
reference values according to the GLI 2012 lung function regression equations

- 6 minute walking distance (meter)
- O2-saturation before and after 6MWT
- Borg scale

- If ventilated:
Duration (h) of mechanical ventilation
NO (%), ECMO yes/no, if yes VA/VV, double lumen vs. single lumen, Flow-rate.

- Safety monitoring
Adverse events, clinical laboratory values (GOT, Creatinine, gGT, blood count, differential, LDH, potassium, steady state drug level), ECG, ophthalmologic review

E.5.2.1

Timepoint(s) of evaluation of this end point

56 / 84 days

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

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

Austria

Italy

Poland

Portugal

Spain

Turkey

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

Yes

F.1.1

Number of subjects for this age range:

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)

Yes

F.1.1.3.1

Number of subjects for this age range:

F.1.1.4

Infants and toddlers (28 days-23 months)

Yes

F.1.1.4.1

Number of subjects for this age range:

F.1.1.5

Children (2-11years)

Yes

F.1.1.5.1

Number of subjects for this age range:

F.1.1.6

Adolescents (12-17 years)

Yes

F.1.1.6.1

Number of subjects for this age range:

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

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)

Treatment after the end of the trial is at the discretion of the investigator.

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

2018-11-28

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-10-01

P. End of Trial
P.	End of Trial Status	Prematurely Ended
P.	Date of the global end of the trial	2020-09-09

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