Clinical Trials Register

Summary
EudraCT Number:	2018-001730-18
Sponsor's Protocol Code Number:	TreatAIN
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2019-04-12
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

2018-001730-18

A.3

Full title of the trial

Phase III, random, one-site, pilot, open, parallell group trial for evaluating the eficacy and safety of electrocoagulation vs topic sinecatechins vs topic cidofovir in the High-grade anal intraepithelial neoplasia in HIV homosexuals males

Ensayo clínico fase III, aleatorizado, unicéntrico, piloto, abierto, de grupos paralelos para valorar la eficacia y seguridad de la electrocoagulación vs sinecatequinas tópicas vs cidofovir tópico en el tratamiento de la neoplasia intraepitelial anal de alto grado, en varones que tienen sexo con hombres con infección por VIH

A.3.1

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

A.3.2

Name or abbreviated title of the trial where available

TreatAIN

A.4.1

Sponsor's protocol code number

TreatAIN

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 Hospital Vall d'Hebron- Institut de Recerca
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	Fundació Hospital Vall d'Hebron- Institut de Recerca
B.5.2	Functional name of contact point	Joaquin Burgos
B.5.3	Address:
B.5.3.1	Street Address	Pg Vall d'Hebron, 119-129
B.5.3.2	Town/ city	Barcelona
B.5.3.3	Post code	08035
B.5.3.4	Country	Spain
B.5.4	Telephone number	34934894172
B.5.6	E-mail	jburgos@vhebron.net

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	Veregen
D.2.1.1.2	Name of the Marketing Authorisation holder	Exeltis Healthcare S.L.
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.3.1	Product name	Veregen
D.3.4	Pharmaceutical form	Ointment
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Cutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Camellia sinensis; Kuntze folium; epigalocatequina galato
D.3.9.3	Other descriptive name	CAMELLIA SINENSIS (GREEN TEA) LEAF EXTRACT
D.3.9.4	EV Substance Code	SUB127233
D.3.10	Strength
D.3.10.1	Concentration unit	% percent
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	1
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	Cidofovir
D.3.4	Pharmaceutical form	Cream
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Rectal use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	CIDOFOVIR
D.3.9.1	CAS number	113852-37-2
D.3.9.4	EV Substance Code	SUB06257MIG
D.3.10	Strength
D.3.10.1	Concentration unit	% percent
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	1
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

High-grade anal intraepithelial neoplasia

Neoplasia intraepitelial anal de alto grado

E.1.1.1

Medical condition in easily understood language

High-grade anal intraepithelial neoplasia

Neoplasia intraepitelial anal de alto grado

E.1.1.2

Therapeutic area

Diseases [C] - Virus Diseases [C02]

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 prove the efficacy and safety non-inferiority of cidofovir 1% ointment or sinecatechins 10% ointment treatment for high grade anal intraepithelial neoplasia with respect to electrocoagulation treatment in HIV-positive men and men who have sex with men.

Demostrar la no inferioridad en cuanto a eficacia y seguridad del tratamiento con cidofovir 1% en pomada tópica o de sinecatequinas 10% en pomada tópica, respecto a la electrocoagulación, para el tratamiento de la neoplasia intraepitelial anal de alto grado (HGAIN) en pacientes varones con sexo con otros varones, con infección por VIH.

E.2.2

Secondary objectives of the trial

-To compare patients proportion with any adverse event during the treatment.
-To describe the proportion of clinic and laboratory adverse events, which imply treatment dropout, in research treatment arm especially (cidofovir and sinecatechins).
-To evaluate the patient satisfaction about the different treatments by pre-established surveys.
-To compare the proportion of decreased extension of HGAIN patients, with absence of regression, 10 weeks (+/- 4 weeks) after end of treatment.
-To compare proportion of Human Papilloma Virus clearance in patients 10 weeks (+/- 4 weeks) after end of treatment.
-To evaluate 10 weeks (+/- 4 weeks) after end of treatment the expression variability of cellular proliferation markers and dysplasia, and their association with treatment result and recurrence.
-To describe the patients proportion with HGAIN recurrence after a complete or partial result, and medium until recurrence.
-To analize the costs of the three treatment arms.

•Comparar la proporción de pacientes con AA durante el tratamiento. •Describir la proporción de AA clínicos y de laboratorio, así como los que condicionan retirada del tratamiento, especialmente en las ramas de tratamiento experimental. •Evaluar la satisfacción del pte mediante cuestionarios predefinidos. •Comparar la proporción de pacientes con disminución de la extensión del HGAIN, en ausencia de regresión, a las 10 ss (+/-4 ss) tras finalizar el tratamiento. •Comparar la proporción de pacientes con aclaramiento del VPH a las 10 ss (+/-4 ss) tras finalizar el tratamiento. •Evaluar la variación en la expresión de marcadores de proliferación celular y de displasia a las 10 ss tras finalizar el tratamiento, y su asociación con la respuesta al tratamiento y la recidiva. •Describir la proporción de pacientes con recidiva del HGAIN en aquellos con respuesta completa o parcial, y la mediana de tiempo hasta la recidiva. • Analizar coste económico de las 3 ramas al final del tratamiento.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

-Men who have sex with men, older or same than 18 years old.
-HIV-1 positive men.
-High grade anal intraepithelial neoplasia recognised by biopsy during 12 months previous to study.
-Informed consent is signed voluntarily.

• Pacientes varones que tienen sexo con otros hombres, de edad igual o superior a 18 años.
• Pacientes infectados por VIH-1.
• Pacientes con HGAIN demostrada por biopsia en los 12 meses previos al estudio.
• Firma voluntaria del consentimiento informado.

E.4

Principal exclusion criteria

-Patient with any disease or condition which rules him out to participate in the research, by investigator opinion.
-Treated patients for HGAIN in the previous 6 months.
-Patients with relapsed HGAIN two or more times in the last three months.
-People with learning difficulties

• Cualquier enfermedad o condición del paciente que, en opinión del investigador, no sea la adecuada para que participe en el estudio.
• Pacientes que han recibido tratamiento previo del HGAIN en los últimos 6 meses.
• Paciente con dos o más recidivas del HGAIN en los últimos 3 años.
• Pacientes incapaces de entender el protocolo del estudio o cualquier otra condición que en opinión del investigador pueda comprometer el cumplimiento del protocolo.
• Historia o presencia de alergia a alguno de los fármacos del estudio o a sus componentes

E.5 End points

E.5.1

Primary end point(s)

The patients proportion with complete or partial regression of HGAIN at 10 weeks (+/-4 weeks) after the end of treatment.

Proporción de pacientes con regresión completa o parcial del HGAIN a las 10 semanas tras finalizar el tratamiento (con una desviación permitida de 4 semanas).

E.5.1.1

Timepoint(s) of evaluation of this end point

At 10 week (+/-4 weeks) after the end of treatment.

10 semanas (+/- 4 semanas) finalizado el tratamiento.

E.5.2

Secondary end point(s)

-Related to HIV infection: CD4+ cell count, HIV viral load, antiretroviral treatment.
-Related to sexual habits: number of sexual partners, condom use, sexually transmitted infections.
-Related to anal dysplasia: Previous anal dysplasia history, recieved
treatments, size and location of actual anal dysplasia, actual anal cellular proliferation markers and after treatment.
-Related to HPV infection: Previous HPV infection, actual and after treatment.
-Related to laboratory alterations: hemogram, renal function, liver function.
-Related to safety: Adverse events during the research.
-Related to compliance: Pre-established survey and collection of leftover medication.

• Relativas a infección por VIH: Linfocitos CD4+, carga viral VIH, tratamiento antirretroviral.
• Relativas a los hábitos sexuales: Número de parejas sexuales, uso de preservativo, enfermedades de transmisión sexual.
• Relativas a displasia anal: Historial previo de displasia anal, tratamientos recibidos, tamaño y localización de displasia anal actual, marcadores de proliferación de displasia anal actual y tras el tratamiento.
• Relativas a la infección por VPH: Infección VPH previa, actual y tras el tratamiento
• Relativas a alteraciones de laboratorio: Hemograma, función renal, función hepática.
• Relativas a la seguridad: Acontecimientos adversos que puedan aparecer.
• Relativas a la adherencia: Cuestionarios predefinidos y recogida de medicación sobrante.

E.5.2.1

Timepoint(s) of evaluation of this end point

During all the reasearch

Durante todo el estudio.

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)

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

Electrocoagulación

Electrocoagulation

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the 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

LVLS

Última visita 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:

100

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

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

108

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)

Standard of care according the site guidelines

Práctica clínica habitual de acuerdo a las guías terapéuticas del centro

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

2019-09-27

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-07-03

P. End of Trial
P.	End of Trial Status	Ongoing

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