Clinical Trials Register

Summary
EudraCT Number:	2019-003957-27
Sponsor's Protocol Code Number:	20115
National Competent Authority:	Portugal - INFARMED
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2020-06-22
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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Portugal - INFARMED

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

Ensaio aleatorizado, com dupla ocultação, de grupos paralelos, controlado por placebo e multicêntrico para avaliar a segurança e a tolerabilidade da administração subcutânea mensal de osocimab em duas coortes, uma de baixa dose e outra de alta dose, em doentes com DRT sujeitos a hemodiálise regular

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

Ensaio para investigar a segurança de um medicamento chamado ososcimab numa dose baixa e numa dose alta em doentes adultos com insuficiência renal que requerem hemodiálise regular

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	004930300139003
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.3.9.3	Other descriptive name	BAY 1213790
D.3.9.4	EV Substance Code	SUB187446
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
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	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
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

Prevenção de eventos tromboembólicos em doentes com doença renal terminal (DRT) em hemodiálise e que estejam em risco de eventos tromboembólicos

E.1.1.1

Medical condition in easily understood language

Prevention of blood clots in end-stage renal disease patients

Prevenção de coágulos sanguíneos em doentes com doença renal terminal

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	21.1
E.1.2	Level	LLT
E.1.2	Classification code	10049910
E.1.2	Term	Thromboembolism prophylaxis
E.1.2	System Organ Class	100000004865

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.1
E.1.2	Level	LLT
E.1.2	Classification code	10066622
E.1.2	Term	Chronic hemodialysis
E.1.2	System Organ Class	100000004865

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.0
E.1.2	Level	PT
E.1.2	Classification code	10077512
E.1.2	Term	End stage renal disease
E.1.2	System Organ Class	10038359 - Renal and urinary 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 clinically assess the safety of different doses of osocimab administered subcutaneously once a month as compared to placebo

Avaliar clinicamente a segurança de doses diferentes de osocimab administrado por via subcutânea uma vez por mês em comparação com placebo

E.2.2

Secondary objectives of the trial

To assess the change of key pharmacodynamic parameter from baseline

Avaliar a alteração do parâmetro-chave de farmacodinâmica em relação ao valor basal

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.

- Participantes devem ter pelo menos 18 anos de idade
- Doentes com DRT em hemodiálise (incluíndo hemodiafiltração) por um período igual ou superior a 3 meses, a receber diálise durante pelo menos 9 horas por semana e estáveis do ponto de vista do Investigador
-Peso corporal de pelo menos 50 Kg
-Homem e/ou mulher. O uso de contraceptivos pelo homem ou mulher deve ser consistente com os regulamentos locais em relação aos métodos de contracepção para utilização dos participantes em ensaios clínicos

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

- Hemorragia recente clinicamente significativa (nos 6 meses anteriores à triagem)
- Hemoglobina (Hb) < 9.0 g/dL na triagem
- Contagem de plaquetas < 100 x 109 /L
- aPTT ou PT > ULN (limite superior do normal)
- Doença hepática associada com ALT > 3x ULN, ou bilirrubina total > 2x ULN com bilirrubina directa > 20% do total
- Hipertensão não controlada sustentada (pressão sanguínea diastólica igual ou superior a 100 mmHg e/ou pressão sanguínea sistólica igual ou superior a 180 mmHg)
- Neoplasia intracraniana conhecida, malformação arteriovenosa ou aneurisma
- Distúrbios hemorrágicos conhecidos, por exemplo doença de von-Willebrand ou Hemofilia A, B ou C
- Eventos tromboembólicos recentes (<3 meses anteriores à triagem), por exemplo síndrome coronário agudo, acidente vascular cerebral ou TEV (excepto trombose de acesso à diálise)
-Cirurgia major recente (< 3 meses anteriores à triagem) ou programada durante a participanção no ensaio
- Insuficiência cardíaca persistente com classificação igual ou superior a 3, classificada de acordo com a New York Heart Association (NYHA)
- A receber terapêutica antiplaquetária excepto ASA diário menor ou igual a 150 mg/dia
- A receber anticoagulação em doses terapêuticas, diferente da anticoagulação padrão durante o procedimento de hemodiálise

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

-Composto de eventos hemorrágicos major e clinicamente relevantes (em alinhamento com as orientações ISTH), conforme avaliado pelo Comité Independente de Adjudicação Central com ocultação
-Combinação de EA moderados e graves e EAG

E.5.1.1

Timepoint(s) of evaluation of this end point

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

Desde a primeira dose no mês 1 e até 6 meses

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 de tromboplastina parcial ativada (aPTT) em níveis mínimos medida pelo método de kaolin-trigger e analisada como proporção para a avaliação inicial
- Actividade do Factor XIa (FXIa) em níveis mínimos avaliada com base num teste de coagulação aPTT usando plasma deficitário em FXI e analisada como proporção para a avaliação inicial

E.5.2.1

Timepoint(s) of evaluation of this end point

At baseline and after 6 months

Na avaliação inicial e após 6 meses

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

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)

O fim do ensaio é definido como a data da Última Visita do Último Participante no ensaio a nível global (UVUP)

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

Nenhum

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

2020-08-10

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-09-21

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2022-05-30

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials