Clinical Trials Register

Summary
EudraCT Number:	2019-003957-27
Sponsor's Protocol Code Number:	20115
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2020-10-21
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

Italy - Italian Medicines Agency

A.2

EudraCT number

2019-003957-27

A.3

Full title of the trial

A randomized, double-blind, parallel group, placebo-controlled, multi-center study to assess the safety and tolerability of monthly subcutaneous administrations of a low and high dose cohort of osocimab to ESRD patients on regular hemodialysis

Studio randomizzato, in doppio cieco, a gruppi paralleli, controllato con placebo, multicentrico, disegnato per valutare la sicurezza e la tollerabilità di somministrazioni sottocutanee mensili di due dosaggi (basso e alto) di Osocimab in pazienti con ESRD sottoposti a regolare emodialisi

A.3.1

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

Study to investigate the safety of a drug called osocimab at low and high doses in adult patients with kidney failure requiring regular hemodialysis

Studio di fase 2b con Osocimab nella ESRD

A.3.2

Name or abbreviated title of the trial where available

CONVERT

A.4.1

Sponsor's protocol code number

20115

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	BAYER AG
B.1.3.4	Country	Germany
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	Bayer AG
B.4.2	Country	Germany
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Bayer AG
B.5.2	Functional name of contact point	Bayer Clinical Trials Contact
B.5.3	Address:
B.5.3.1	Street Address	N/A
B.5.3.2	Town/ city	Berlin
B.5.3.3	Post code	13342
B.5.3.4	Country	Germany
B.5.4	Telephone number	000000
B.5.5	Fax number	000000
B.5.6	E-mail	clinical-trials-contact@bayer.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	BAY 1213790
D.3.2	Product code	[BAY 1213790]
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	Osocimab
D.3.9.1	CAS number	2056878-75-0
D.3.9.2	Current sponsor code	BAY 1213790
D.3.9.4	EV Substance Code	SUB187446
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	150
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Solution for injection
D.8.4	Route of administration of the placebo	Subcutaneous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Prevention of thromboembolic events in ESRD patients on hemodialysis who are at risk for thromboembolic events

Prevenzione di eventi tromboembolici in Pazienti ESRD in emodialisi, a rischio per eventi tromboembolici.

E.1.1.1

Medical condition in easily understood language

Prevention of blood clots in end-stage renal disease patients

Prevenzione di coaguli di sangue in Pazienti con malattia renale allo stadio terminale

E.1.1.2

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

MedDRA Classification

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 clinically assess the safety of different doses of osocimab administered subcutaneously once a month as compared to placebo

Valutare clinicamente la sicurezza di dosi diverse di Osocimab, somministrato per via sottocutanea una volta al mese durante la fase di trattamento principale, rispetto a placebo

E.2.2

Secondary objectives of the trial

To assess the change of key pharmacodynamic parameter from baseline

Valutare la variazione del principale parametro PD rispetto al basale

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Participants must be at least 18 years of age
• Patients with end-stage renal disease on hemodialysis (including hemodiafiltration) for =3 months, receiving dialysis at least 9 hours a week and stable in the view of the investigator
• Body weight of at least 50 kg
• Male and/or female. Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

I partecipanti sono ritenuti eleggibili per lo studio soltanto se si applicano tutti i seguenti criteri:
Età
1. I partecipanti devono avere almeno 18 anni
Tipologia del partecipante e caratteristiche della malattia
2. Pazienti con malattia renale allo stadio terminale in emodialisi (inclusa emodiafiltrazione) da =3 mesi, sottoposti a dialisi per almeno 9 ore a settimana e considerati stabili dallo sperimentatore
Peso
3. Peso corporeo di almeno 50 kg
Sesso
4. Pazienti di sesso maschile e/o femminile
Il metodo contraccettivo utilizzato dai pazienti di sesso maschile o femminile deve essere conforme alle normative locali in materia di contraccezione per i partecipanti a studi clinici. Per maggiori informazioni consultare la sezione 10.4.
Consenso informato
5. Capacità di fornire il consenso informato firmato, descritto nella sezione 10.1.3, che include la conformità ai requisiti e alle restrizioni elencati nel consenso informato stesso (ICF) e in questo protocollo

E.4

Principal exclusion criteria

• Recent (<6 months before screening) clinically significant bleeding
• Hemoglobin (Hb) < 9.0 g/dL at screening
• Platelet count < 100 x 109/L
• aPTT or PT > ULN (upper limit of normal)
• Hepatic disease associated with ALT > 3x ULN, or total bilirubin >2x ULN with direct bilirubin > 20% of the total
• Sustained uncontrolled hypertension (diastolic blood pressure =100 mmHg and/or systolic blood pressure = 180 mmHg)
• Known intracranial neoplasm, arteriovenous malformation or aneurysm
• Known bleeding disorders e.g. von-Willebrand disease or Hemophilia A, B or C
• Recent (<3 months before screening) thromboembolic event, e.g. acute coronary syndrome, stroke or VTE (except dialysis access thrombosis)
• Recent (<3 months before screening) major surgery or scheduled major surgery during study participation
• Scheduled living donor renal transplant during study participation
• Persistent heart failure as classified by the New York Heart Association (NYHA) classification of 3 or higher
• Receiving antiplatelet therapy except daily ASA = 150 mg/day
• Receiving anticoagulation in therapeutic doses, other than standard anticoagulation during the hemodialysis procedure

I partecipanti sono esclusi dallo studio qualora si applichi uno qualsiasi dei seguenti criteri:
Condizioni mediche
1. Emorragia clinicamente significativa recente (<6 mesi prima dello screening)
2. Emoglobina (Hb) <9,0 g/dl
3. Conta delle piastrine <100 x 109/l
4. aPTT o PT > ULN (limite superiore rispetto al normale)
5. Malattia epatica associata ad ALT >3 x ULN o bilirubina totale >2 x ULN con bilirubina diretta >20% della bilirubina totale
6. Ipertensione sostenuta non controllata (pressione arteriosa diastolica =100 mmHg e/o pressione arteriosa sistolica =180 mmHg)
7. Neoplasia intracranica nota, malformazione arterovenosa o aneurisma
8. Disturbi emorragici noti, ad es. malattia di von Willebrand o emofilia A, B o Cm
9. Evento tromboembolico recente (<3 mesi prima dello screening), ad es. sindroe coronarica acuta, ictus o TEV (ad esclusione della trombosi dell’accesso dialitico)
10. Intervento chirurgico maggiore recente (<3 mesi prima dello screening) o programmato durante la partecipazione allo studio
11. Trapianto renale programmato da donatore vivente durante la partecipazione allo studio
12. Insufficienza cardiaca persistente di classe III o superiore in base alla classificazione della New York Heart Association (NYHA)
13. Assunzione di terapia antiaggregante, ad esclusione di trattamento giornaliero con ASA (acido acetilsalicilico) =150 mg/die
14. Assunzione di anticoagulanti in dosi terapeutiche, diversi da anticoagulanti standard durante la procedura di emodialisi
15. Aspettativa di vita inferiore a 6 mesi
16. Tumore maligno in atto che necessita di trattamento durante la partecipazione allo studio (ad esclusione del carcinoma cutaneo non melanoma o del carcinoma cervicale in situ)
17. Ipersensibilità nota al farmaco sperimentale o ai suoi eccipienti
Esperienza precedente/concomitante di studio clinico
18. Partecipazione a un altro studio clinico con un farmaco sperimentale entro 30 giorni oppure, se di durata superiore, entro 5 emivite dello stesso, prima della randomizzazione e durante lo studio

E.5 End points

E.5.1

Primary end point(s)

• Composite of major and clinically-relevant non-major bleeding events (in alignment with ISTH guidelines), as assessed by blinded Central Independent Adjudication Committee (CIAC)
• Composite of moderate and severe AEs and SAEs

• Composito di eventi emorragici maggiori o non maggiori ma clinicamente rilevanti (in accordo con le linee guida ISTH), in base alla valutazione in cieco del Comitato di Validazione Centrale Indipendente (CIAC)
• Composito di AE e SAE moderati e gravi

E.5.1.1

Timepoint(s) of evaluation of this end point

From the first dose at month 1 and up to 6 months

Dalla prima dose al mese 1 fino ai 6 mesi

E.5.2

Secondary end point(s)

• Activated partial thromboplastin time (aPTT) at trough levels measured by the kaolin-trigger method and analyzed as ratio to baseline
• Factor XIa (FXIa) activity at trough levels assessed with an aPTT-based coagulation test using FXI deficient plasma and analyzed as ratio to baseline

• Tempo di tromboplastina parziale attivata (aPTT), attività del FXIa presente ai livelli di valle del farmaco, dopo 6 mesi

E.5.2.1

Timepoint(s) of evaluation of this end point

At baseline and after 6 months

Al basale e dopo 6 mesi

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

Yes

E.6.3

Therapy

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

Yes

E.6.10

Pharmacogenetic

Yes

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

Information not present in EudraCT

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

Belgium

Bulgaria

China

Czech Republic

France

Greece

Hungary

Israel

Italy

Japan

Lithuania

Netherlands

Poland

Portugal

Russian Federation

Spain

Ukraine

United States

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

The end of the study is defined as the date of the last visit of the last subject in the study globally (LVLS)

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:

435

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

315

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

410

F.4.2.2

In the whole clinical trial

750

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

2020-08-07

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-07-16

P. End of Trial
P.	End of Trial Status	Completed

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Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
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