Clinical Trials Register

Summary
EudraCT Number:	2020-001048-24
Sponsor's Protocol Code Number:	NN7769-4514
National Competent Authority:	Lithuania - SMCA
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2021-02-09
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

Lithuania - SMCA

A.2

EudraCT number

2020-001048-24

A.3

Full title of the trial

A multinational, open-label, randomised, controlled trial to investigate efficacy and safety of NNC0365-3769 (Mim8) in adults and adolescents with haemophilia A with or without inhibitors.

Daugiatautis, atviras, atsitiktinių imčių, kontroliuojamas tyrimas, skirtas tirti NNC0365-3769 (Mim8) veiksmingumą ir saugumą suaugusiesiems ir paaugliams, sergantiems hemofilija A su inhibitoriais ar be jų.

A.3.1

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

A research study investigating Mim8 in adults and adolescents with haemophilia A with or without inhibitors

Ištirti Mim8 saugumą suaugusiesiems ir paaugliams, sergantiems hemofilija A, kuriems yra arba nėra nustatyta FVIII inhibitorių.

A.4.1

Sponsor's protocol code number

NN7769-4514

A.5.3

WHO Universal Trial Reference Number (UTRN)

U1111-1249-4378

A.7

Trial is part of a Paediatric Investigation Plan

Yes

A.8

EMA Decision number of Paediatric Investigation Plan

P/450/2020

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Novo Nordisk A/S
B.1.3.4	Country	Denmark
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	Novo Nordisk A/S
B.4.2	Country	Denmark
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Novo Nordisk A/S
B.5.2	Functional name of contact point	Clinical Transparency (1452)
B.5.3	Address:
B.5.3.1	Street Address	Novo Allé
B.5.3.2	Town/ city	Bagsværd
B.5.3.3	Post code	2880
B.5.3.4	Country	Denmark
B.5.6	E-mail	clinicaltrials@novonordisk.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	NNC0365-3769 A
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	N/A
D.3.9.1	CAS number	MASKED
D.3.9.2	Current sponsor code	NNC0365-3769
D.3.9.4	EV Substance Code	SUB198393
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	10 to 100
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	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	Yes
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

Haemophilia A
Haemophilia A with inhibitors

Hemofilija A
Hemofilija A su Inhibitoriais

E.1.1.1

Medical condition in easily understood language

Haemophilia A
Haemophilia A with inhibitors

Hemofilija A
Hemofilija A su Inhibitoriais

E.1.1.2

Therapeutic area

Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

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	10018938
E.1.2	Term	Haemophilia A (Factor VIII)
E.1.2	System Organ Class	10010331 - Congenital, familial and genetic disorders

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	10053751
E.1.2	Term	Hemophilia A with anti factor VIII
E.1.2	System Organ Class	10010331 - Congenital, familial and genetic 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

To confirm the haemostatic effect of Mim8 as treatment prophylaxis for adult and adolescent patients with haemophilia A with or without inhibitors.

Patvirtinti profilaktikai skiriamo Mim8 hemostazinį poveikį tyrime dalyvaujantiems suaugusiesiems ir paaugliams, sergantiems hemofilija A, kuriems yra arba nėra nustatyta inhibitorių.

E.2.2

Secondary objectives of the trial

1. To investigate safety of Mim8 prophylaxis in adults and adolescents with haemophilia A with or without FVIII inhibitors.
2. To evaluate the consumption of factor product per bleed treatment (number of injections) after Mim8 prophylaxis in adults and adolescents with haemophilia A with or without inhibitors.
3. To evaluate the development of anti-Mim8 antibodies after Mim8 prophylaxis in adults and adolescents with haemophilia A with or without inhibitors.
4. To evaluate treatment burden after Mim8 prophylaxis in adults and adolescents with haemophilia A with or without inhibitors.
5. To evaluate aspects of patient’s physical functioning after Mim8 prophylaxis in adults and adolescents with haemophilia A with or without inhibitors.
6. To evaluate joint pain intensity after Mim8 prophylaxis in adults and adolescents with haemophilia A with or without inhibitors.

1.Patvirtinti profilaktikai skiriamo Mim8 hemostazinį poveikį tyrime dalyvaujantiems suaugusiesiems ir paaugliams,sergantiems hemof.A,kuriems yra arba nėra nustatyta inhibitorių
2.Įvertinti krešėjimo faktoriaus preparato suvartojimą kiekvieno kraujavimo atvejo gydymo metu(injekcijų skaičių)po Mim8 skyrimo profilaktikai suaugusiesiems ir paaugliams,sergantiems hemof.A,kuriems
yra arba nėra nustatyta inhibitorių
3.Įvertinti antikūnų prieš Mim8 susidarymą po Mim8 skyrimo profilaktikai suaugusiesiems ir paaugliams,sergantiems hemof.A,kuriems yra arba nėra nustatyta inhibitorių
4.Įvertinti gydymo naštą po Mim8 profilaktikos suaugusiems ir paaugliams,sergantiems hemof.A su inhibitoriais arba be jų
5.Įvertinti paciento fizinio funkcionavimo aspektus po Mim8 profilaktikos suaugusiems ir paaugliams,sergantiems hemof. A su inhibitoriais arba be jų
6.Įvertinti sąnarių skausmo intensyvumą po Mim8 profilaktikos suaugusiems ir paaugliams,sergantiems A hemofilija su inhibitoriais arba be jų.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
- Male or female with diagnosis of congenital haemophilia A of any severity based on medical records
- Patient has been prescribed, or in need of, treatment with factor VIII or bypassing agent in the last 26 weeks prior to screening
- Age above or equal to 12 years at the time of signing informed consent. Germany, Japan and Taiwan: Local requirements apply
- Body weight above or equal to 30 kg
- Applicable to patients on emicizumab prophylaxis: patient is willing to discontinue emicizumab at the time of screening
- Applicable to patients treated with no prophylaxis prior to enrolment: 5 or more bleeds in the last 26 weeks prior to screening visit
- Applicable to patients with FVIII activity above 1% who are on prophylactic treatment: 1 or more bleeds in the last 26 weeks prior to screening visit
- Willingness and ability to comply with scheduled visits and study procedures, including the completion of diary and patient-reported outcomes questionnaires

-Informuoto asmens sutikimo gavimas prieš bet kokių su tyrimu susijusių veiksmų atlikimą. Su tyrimu susiję veiksmai – tai bet kokios tyrimo tikslais atliekamos procedūros, įskaitant veiksmus tinkamumui
dalyvauti tyrime nustatyti.
-Vyras arba moteris su bet kokio sunkumo įgimtos hemofilijos A diagnoze, remiantis medicinine dokumentacija.
-Pacientas, kuriam per paskutines 26 savaites iki atrankos buvo paskirtas gydymas VIII faktoriaus preparatu arba krešėjimo sistemą apeinančiu preparatu arba nustatytas tokio gydymo poreikis.
-Amžius nuo 12 metų imtinai informuoto asmens sutikimo pasirašymo metu. Vokietija, Japonija ir Taivanas: prašome žr. 9 priede (10.9 skyrius) pateiktus vietoje galiojančius reikalavimus.
-Kūno svoris ≥ 30 kg.
-Taikoma pacientams, kuriems profilaktikai paskirtas emicizumabas: paciento pasirengimas nutraukti emicizumabo vartojimą, vertinant atrankos metu.
-Taikoma jokio profilaktinio gydymo iki registracijos dalyvauti tyrime negavusiems pacientams: ≥ 5 kraujavimo atvejai per paskutines 26 savaites iki atrankos vizito.
-Taikoma profilaktinį gydymą gaunantiems pacientams, kurių FVIII aktyvumas > 1 %: ≥ 1 kraujavimo atvejis per paskutines 26 savaites iki atrankos vizito.
-Pasirengimas ir gebėjimas dalyvauti planiniuose vizituose ir tyrimo procedūrose, įskaitant dienyno ir pacientų nurodomų baigčių klausimynų pildymą.

E.4

Principal exclusion criteria

- Previous participation in this trial. Participation is defined as signed informed consent
- Participation in any clinical trial of an approved or non-approved investigational medicinal product, within 30 days (or 5 half-lives of the investigational medicinal product, whichever is greater) before screening
- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method (highly effective contraceptive measures as defined in the protocol or as required by local regulation or practice). Breast feeding is allowed only during the run-in period
- Any disorder, except for conditions associated with haemophilia A, which in the investigator’s opinion might jeopardise subject’s safety or compliance with the protocol
- Known or suspected hypersensitivity to trial product(s), any constituents of the product or to related products
- Receipt of gene therapy at any given time point
- Ongoing or planned immune tolerance induction (ITI) therapy
- Major surgery planned at the time of screening
- Known congenital or acquired coagulation disorders other than haemophilia A
- Hepatic dysfunction defined as aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) above 3 times the upper limit combined with total bilirubin above 1.5 times the upper limit measured at screening
- Renal impairment defined as estimated Glomerular Filtration Rate (eGFR) below or equal to 30 ml/min/1.73 m^2 for serum creatinine measured at screening
- Previous or current thromboembolic disease or events (includes arterial and venous thrombosis including myocardial infarction, thrombotic microangiography (TMA), pulmonary embolism, cerebral infarction/thrombosis, deep vein thrombosis, other clinically significant thromboembolic events and peripheral artery occlusion) (with the exception of previous catheter-associated thrombosis for which anti-thrombotic treatment is not currently ongoing) or risk of thromboembolic disease, as evaluated by investigator
- Mental incapacity, unwillingness to cooperate, or a language barrier precluding adequate understanding and cooperation
- Other conditions (e.g. autoimmune disease) or laboratory abnormality that may increase risk of bleeding or thrombosis as evaluated by the investigator

-Ankstesnis dalyvavimas šiame tyrime. Dalyvavimas apibrėžiamas kaip pasirašytas informuoto asmens sutikimas.
-Dalyvavimas bet kokiame klinikiniame patvirtinto arba nepatvirtinto tiriamojo vaistinio preparato tyrime 30 dienų laikotarpiu (arba 5 atitinkamo tiriamojo vaistinio preparato pusėjimo trukmes atitinkančiu
laikotarpiu) iki atrankos.
-Nėščios, krūtimi maitinančios arba pastoti ketinančios moterys, taip pat vaisingo amžiaus moterys, nenaudojančios itin veiksmingo kontracepcijos metodo (10.4 skyriuje apibrėžtų arba remiantis vietoje galiojančiais reikalavimais ar praktika nustatytų itin veiksmingų kontracepcijos priemonių). Maitinimas krūtimi leistinas tik parengiamojo etapo metu.
-Bet koks sutrikimas, išskyrus su hemofilija A susijusias būkles, kuris,tyrėjo nuomone, gali kelti grėsmę tiriamojo asmens saugumui arba protokolo reikalavimų laikymuisi.
-Žinomas arba įtariamas padidėjęs jautrumas tyrimo laikotarpiu skiriamam preparatui (-ams), jo (jų) sudedamosioms dalims arba panašiems preparatams.
-Genų terapijos taikymas bet kuriuo metu
-Taikoma arba planuojama taikyti ITI terapija.
-Planuojama didelės apimties operacija, vertinant atrankos metu. Žr. didelės apimties operacijos apibrėžimą Protokolo 6–7 lentelėje.
-Žinomi įgimti arba įgyti krešėjimo sutrikimai, išskyrus hemofiliją A.
-Kepenų funkcijos sutrikimas, apibrėžiamas kaip AST ir (arba) ALT kiekis, > 3 kartus viršijantis viršutinę ribą, kartu su bendro bilirubino kiekiu, > 1,5 karto viršijančiu viršutinę ribą, vertinant atrankos metu.
-Inkstų funkcijos pablogėjimas, apibrėžiamas kaip apskaičiuotasis glomerulų filtracijos greitis (aGFG) ≤ 30 ml/min/1.73 m2, remiantis atrankos metu nustatytu kreatinino kiekiu serume.
-Tromboembolinė liga arba reiškiniaia anamnezėje arba šiuo metu (išskyrus su kateteriu susijusią trombozę anamnezėje, dėl kurios šiuo metu netaikomas antitrombozinis gydymas) arba tromboembolinės ligos
rizika tyrėjo vertinimu.
-Neveiksnumas dėl psichikos sutrikimo, nenoras bendradarbiauti arba kalbos barjeras, kliudantis tinkamai suprasti ir bendradarbiauti.
-Kitos būklės (pavyzdžiui, autoimuninė liga) arba laboratoriniais tyrimais nustatyta patologija, dėl kurių gali būti didesnė kraujavimo arba trombozės rizika tyrėjo vertinimu.

E.5 End points

E.5.1

Primary end point(s)

Number of treated bleeds

Gydytų kraujavimų skaičius

E.5.1.1

Timepoint(s) of evaluation of this end point

- No prophylaxis treatment (Arms 1 and 2): From randomisation (week 0) to end of main (week 26)
- Prophylaxis treatment (Arms 3 and 4): From initiation of run-in (26-52 weeks prior to week 0) to week 0 and from randomisation (week 0) to end of main (week 26)

-Jokio profilaktinio gydymo (1-oji ir 2-oji atšakos):
Nuo tiriamojo vaistinio preparato skyrimo atsitiktinės atrankos būdu (0-inę savaitę) iki pagrindinio etapo pabaigos (26-ąją savaitę)
-Profilaktinis gydymas (3-ioji ir 4-oji atšakos):
Nuo parengiamojo etapo pradžios (pieš 26–56 savaites iki 0-inės savaitės) iki 0-inės savaitės ir nuo tiriamojo vaistinio preparato skyrimo atsitiktinės atrankos būdu (0-inę savaitę) iki pagrindinio etapo pabaigos (26-ąją savaitę)

E.5.2

Secondary end point(s)

1. Number of injection site reactions
2. Occurrence of antiMim8 antibodies
3. Number of treated spontaneous bleeds
4. Number of treated joint bleeds
5. Number of treated traumatic bleeds
6. Number of target joint bleeds
7. Consumption of factor product per bleed treatment (number of injections)
8. Change in physical function domain of paediatric quality of life inventory (PEDS-QL)
9. Change in patient’s treatment burden using the haemophilia treatment experience measure (Hemo-TEM)
10. Change in patient’s joint pain score using Joint Pain Rating Scale

1. Reakcijų injekcijos vietoje skaičius
2. Antikūnų prieš Mim8 atsiradimas
3. Gydytų spontantinio kraujavimo atvejų skaičius
4. Gydytų kraujavimo į sąnarius atvejų skaičius
5. Gydytų trauminio kraujavimo atvejų skaičius
6. Gydytų kraujavimo į tikslinius sąnarius atvejų skaičius
7. Krešėjimo faktoriaus preparato suvartojimas kiekvieno kraujavimo
atvejo gydymo metu (injekcijų skaičius)
8. PEDS-QL Fizinės funkcijos dalies įverčio pokytis
9. Paciento gydymo naštos pokytis, remiantis Hemo-TEM
10. Paciento sąnarių skausmo įverčio pokytis, remiantis Sąnarių skausmo vertinimo skale

E.5.2.1

Timepoint(s) of evaluation of this end point

1. All subjects receiving Mim8 (Arms 2, 3 and 4): From randomisation (week 0) to end of main (week 26)
2. All subjects receiving Mim8 (Arms 2, 3 and 4): From randomisation (week 0) to end of extension (week 52)
3. – 7.:
- No prophylaxis treatment (Arms 1 and 2): From randomisation (week 0) to end of main (week 26)
- Prophylaxis treatment (Arms 3 and 4): From initiation of run-in (26-52 weeks prior to week 0) to week 0 and from randomisation (week 0) to end of main (week 26)
8. – 10.:
All subjects (Arms 1, 2, 3 and 4): From randomisation (week 0) to the end of the main part (week 26)

1. Visi Mim8 gaunantys tiriamieji asmenys (2-oji, 3-ioji ir 4-oji atšakos):Nuo tiriamojo vaistinio preparato skyrimo atsitiktinės atrankos būdu (0-inę savaitę) iki pagrindinio etapo pabaigos (26-ąją savaitę)
2. Visi Mim8 gaunantys tiriamieji asmenys (2-oji, 3-ioji ir 4-oji atšakos):Nuo tiriamojo vaistinio preparato skyrimo atsitiktinės atrankosbūdu (0-inę savaitę) iki tęstinio etapo pabaigos (52-ąją savaitę)
3.-7.: Jokio profilaktinio gydymo (1-oji ir 2-oji atšakos):Nuo tiriamojo vaistinio preparato skyrimo atsitiktinės atrankos būdu (0-inę savaitę) iki pagrindinio etapo pabaigos (26-ąją savaitę) Profilaktinis gydymas (3-ioji ir 4-oji atšakos): žr. protokolo santrauką.
8-10 Visi tiriamieji asmenys (1-oji, 2-oji, 3-ioji ir 4-oji atšakos):žr. protokolo santrauką.

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

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

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

Yes

E.8.1.7.1

Other trial design description

Intra-individual (within-patient) comparison

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

Yes

E.8.2.3.1

Comparator description

Different treatment regimen of Mim8

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

Switzerland

Taiwan

Canada

China

India

Israel

Japan

Korea, Republic of

Russian Federation

Saudi Arabia

Serbia

South Africa

United Kingdom

United States

European Union

Türkiye

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

Paskutinio paciento paskutinis vizitas

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)

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)

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:

190

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

230

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)

Subjects are invited to continue participation in Clinical trial NN7769-4532

Tiriamieji kviečiami tęsti dalyvavimą klinikiniame tyrime NN7769-4532

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

2021-06-25

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-04-29

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2024-12-17

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IMP with orphan designation in the indication
Orphan Designation Number:
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