Clinical Trials Register

Summary
EudraCT Number:	2018-003300-39
Sponsor's Protocol Code Number:	FCO-CYT-2018-01
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2018-10-25
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

Spain - AEMPS

A.2

EudraCT number

2018-003300-39

A.3

Full title of the trial

Clinical trial of efficacy and safety of the combination of reduced duration prophylaxis followed by immuno-guided prophylaxis in lung transplant recipients.

Ensayo clínico de eficacia y seguridad de la combinación de profilaxis de duración reducida seguida de profilaxis inmunoguiada en receptores de trasplante pulmonar.

A.3.1

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

Clinical trial of efficacy and safety of the combination of reduced duration prophylaxis followed by immuno-guided prophylaxis in lung transplant recipients.

Ensayo clínico de eficacia y seguridad de la combinación de profilaxis de duración reducida seguida de profilaxis inmunoguiada en pacientes transplantados de pulmón.

A.3.2

Name or abbreviated title of the trial where available

CYTOCOR

A.4.1

Sponsor's protocol code number

FCO-CYT-2018-01

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT03699254

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	Fundación para la Investigación Biomédica de Córdoba
B.1.3.4	Country	Spain
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	Instituto de Salud Carlos III
B.4.2	Country	Spain
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Fundación para la Investigación Biomédica de Córdoba
B.5.2	Functional name of contact point	Antonio Miguel Luque Pineda
B.5.3	Address:
B.5.3.1	Street Address	Avenida Menéndez Pidal S/N
B.5.3.2	Town/ city	Córdoba
B.5.3.3	Post code	14004
B.5.3.4	Country	Spain
B.5.4	Telephone number	0034957011040
B.5.5	Fax number	0034957736571
B.5.6	E-mail	uicec@imibic.org

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	Yes
D.2.1.1.1	Trade name	VALCYTE
D.2.1.1.2	Name of the Marketing Authorisation holder	Roche Farma, S.A.
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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.3.4	Pharmaceutical form	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	VALGANCICLOVIR HYDROCHLORIDE
D.3.9.1	CAS number	175865-59-5
D.3.9.4	EV Substance Code	SUB16471MIG
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	450
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	Yes
D.2.1.1.1	Trade name	CYMEVENE
D.2.1.1.2	Name of the Marketing Authorisation holder	Roche Farma, S.A.
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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.3.4	Pharmaceutical form	Powder for concentrate for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	GANCICLOVIR SODIUM
D.3.9.1	CAS number	107910-75-8
D.3.9.4	EV Substance Code	SUB02312MIG
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	500
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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Cytomegalovirus Infection in subjects who underwent lung transplantation.

Infección por citomegalovirus en pacientes trasplantados de pulmón.

E.1.1.1

Medical condition in easily understood language

Virus Infection in subjects who underwent lung transplantation.

Infección por virus en pacientes trasplantados de pulmón.

E.1.1.2

Therapeutic area

Diseases [C] - Virus Diseases [C02]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.1
E.1.2	Level	PT
E.1.2	Classification code	10011831
E.1.2	Term	Cytomegalovirus infection
E.1.2	System Organ Class	10021881 - Infections and infestations

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	10010187
E.1.2	Term	Complications of transplanted lung
E.1.2	System Organ Class	10022117 - Injury, poisoning and procedural complications

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	10025127
E.1.2	Term	Lung transplant
E.1.2	System Organ Class	10042613 - Surgical and medical procedures

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 assess the efficacy of reduced duration prophylaxis followed by immuno-guided prophylaxis to prevent cytomegalovirus disease.

Evaluar la eficacia de la profilaxis de duración reducida seguida de la profilaxis inmunoguiada para evitar la enfermedad por citomegalovirus.

E.2.2

Secondary objectives of the trial

In those subjects recruited within the experimental arm who develop citomegalovirus disease despite receiving the immuno-guided prophylaxis based on QF-reactive (cut-off point of 0.2 UI/mL), it will be assessed if a different cut-off point might predict the protection against the disease with greater reliability.

En aquellos pacientes del brazo experimental en los que, utilizando la profilaxis inmunoguiada basada en QF-reactivo (cut-off 0.2 UI/mL), el paciente desarrolle enfermedad por citomegalovirus, un objetivo secundario será valorar si un punto de corte diferente podría predecir con mayor fiabilidad protección frente a la enfermedad.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Subjects with cytomegalovirus positive serology who underwent lung transplantation.
Subjects of 18 years of age or older.
Expected valgancilovir prophylactic treatment of 6 months after transplantation.
Patients who have signed the informed consent form.

Trasplantados pulmonares con serología citomegalovirus positiva pretrasplante.
Mayores de 18 años.
Que el tiempo previsto de profilaxis con valganciclovir sea de 6 meses posttrasplante.
Pacientes que hayan otorgado su consentimiento informado por escrito.

E.4

Principal exclusion criteria

HIV infected subjects.
Pregnant and/or lactating women.
Intolerance to Valganciclovir/Ganciclovir.
Subjects unable to comply with the protocolo follow-up visits.
Subjects who underwent multivisceral transplant.

Pacientes infectados por VIH.
Embarazadas y/o mujeres en período de lactancia.
Intolerancia hacia el Valganciclovir/Ganciclovir.
Pacientes que no puedan cumplir con el protocolo de seguimiento.
Pacientes con trasplante multivisceral.

E.5 End points

E.5.1

Primary end point(s)

Cytomegalovirus disease incidence rate at 18 months after lung transplantation.

Incidencia de enfermedad por citomegalovirus a los 18 meses del trasplante pulmonar.

E.5.1.1

Timepoint(s) of evaluation of this end point

18 months after lung transplantation.

A los 18 meses del trasplante pulmonar.

E.5.2

Secondary end point(s)

Effectiveness endpoint:
- Replication by cytomegalovirus incidence rate.
Explanatory endpoints:
- Demographic: age, gender and baseline disease.
- Type of transplant: single or double lung transplant.
- Before transplant cytomegalovirus serology.
- HLA) typing for donor and recipient subjects.
- Immunosuppressive induction treatment: dose and duration.
- Immunosuppressive maintenance treatment: dose and duration.
- Antiviral treatment against cytomegalovirus: dose and duration.
- Other opportunistic infections not associated with cytomegalovirus: bacterial, viral and fungal.
- Acute or chronic rejection of the transplant: time elapsed since the transplant, number of episodes and treatment.
- Adverse events attributable to antiviral treatment against cytomegalovirus.
Security Variables:
- Incidence and severity of adverse events.

Variables de eficacia:
- Incidencia de replicación por citomegalovirus.
Variables explicativas:
- Demográficas: edad, sexo y enfermedad de base.
- Tipo de trasplante: unipulmonar o bipulmonar.
- Serología citomegalovirus pretrasplante.
- Tipaje HLA donante y receptor.
- Tratamiento Inmunosupresor de inducción: dosis y duración.
- Tratamiento Inmunosupresor de mantenimiento: dosis y duración.
- Tratamiento antiviral frente a citomegalovirus: dosis y duración.
- Otras infecciones oportunistas no asociadas a citomegalovirus: bacterianas, víricas y fúngicas.
- Rechazo agudo o crónico del injerto: tiempo trascurrido desde el trasplante, número de episodios y tratamiento.
- Efectos adversos atribuibles al tratamiento antiviral frente a citomegalovirus.
Variables de Seguridad:
- Incidencia y severidad de los acontecimientos adversos.

E.5.2.1

Timepoint(s) of evaluation of this end point

In every trial visit:
Visit 1: within 30 days after lung transplantation.
Visit 2: 30 days after lung transplantation.
Visit 3: 60 days after lung transplantation.
Visit 4: 90 days after lung transplantation.
Visit 5: 120 days after lung transplantation.
Visit 6: 150 days after lung transplantation.
Visit 7: 180 days after lung transplantation.
Visit 8: 210 days after lung transplantation.
Visit 9: 240 days after lung transplantation.
Visit 10: 270 days after lung transplantation.
Visit 11: 300 days after lung transplantation.
Visit 12: 330 days after lung transplantation.
Visit 13: 360 days after lung transplantation.
Visit 14: 450 days after lung transplantation.
Visit 15: 540 days after lung transplantation.

En cada visita del estudio
Visita 1: dentro de los 30 días posteriores al trasplante pulmonar.
Visita 2: 30 después del trasplante pulmonar.
Visita 3: 60 después del trasplante pulmonar.
Visita 4: 90 después del trasplante pulmonar.
Visita 5: 120 después del trasplante pulmonar.
Visita 6: 150 después del trasplante pulmonar.
Visita 7: 180 después del trasplante pulmonar.
Visita 8: 210 después del trasplante pulmonar.
Visita 9: 240 después del trasplante pulmonar.
Visita 10: 270 después del trasplante pulmonar.
Visita 11: 300 después del trasplante pulmonar.
Visita 12: 330 después del trasplante pulmonar.
Visita 13: 360 después del trasplante pulmonar.
Visita 14: 450 después del trasplante pulmonar.
Visita 15: 540 después del trasplante pulmonar.

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

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

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

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Terapia estándar

Standard therapy

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

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

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

Last visit of the last subject.

Última visita del último paciente.

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

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:

127

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

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

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

150

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.

Ninguno.

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

2018-12-21

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-11-02

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2023-05-29

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