Clinical Trials Register

Summary
EudraCT Number:	2013-002579-16
Sponsor's Protocol Code Number:	FFF/2013
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:	2014-11-04
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

2013-002579-16

A.3

Full title of the trial

PHASE III CLINICAL TRIAL, single-center, randomized, double blind IN TWO GROUPS PARALLELS TO COMPARE THE EFFICACY AND SAFETY OF RICH PLASMA GROWTH FACTORS (PRGF) IN FRONT OF fibrin glue (TISSUCOL ®) FOR SEALING ANAL AND CRIPTOGLANDULAR FISTULA AFTER 48 WEEKS

ENSAYO CLÍNICO FASE III, UNICÉNTRICO, ALEATORIZADO, DOBLE CIEGO EN DOS GRUPOS PARALELOS PARA COMPARAR LA EFICACIA Y SEGURIDAD DEL PLASMA RICO EN FACTORES DE CRECIMIENTO (PRGF) FRENTE AL ADHESIVO DE FIBRINA (TISSUCOL®) PARA EL SELLADO DE LAS FÍSTULA ANALES DE ORIGEN CRIPTOGLANDULAR TRAS UN PERIODO DE 48 SEMANAS

A.3.1

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

Study to determine how safe and effective is a therapy for the treatment of anal fistula, compared with another treatment that is considered of choice for this disease

Estudio para determinar como es de seguro y eficaz un tratamiento para el tratamiento de la fístula anal, en comparación con otro tratamiento que se considera de elección para esta enfermedad

A.3.2

Name or abbreviated title of the trial where available

FFF2013

A.4.1

Sponsor's protocol code number

FFF/2013

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	C. HOSPITALARIO VIRGEN DEL ROCIO
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	FISEVI
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	C. HOSPITALARIO VIRGEN DEL ROCIO
B.5.2	Functional name of contact point	FUNDACION GESTION INVESTIGACION SEV
B.5.3	Address:
B.5.3.1	Street Address	AVDA MANUEL SIUROT S/N
B.5.3.2	Town/ city	SEVILLE
B.5.3.3	Post code	41013
B.5.3.4	Country	Spain
B.5.4	Telephone number	+34955012292
B.5.6	E-mail	mariavmaestre@gmail.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	PLATELET RICH FACTORS
D.3.4	Pharmaceutical form	Rectal solution
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intralesional use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PRGF
D.3.9.3	Other descriptive name	PLATELETS
D.3.9.4	EV Substance Code	SUB25592
D.3.10	Strength
D.3.10.1	Concentration unit	% percent
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	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	Yes
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	Comparator
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	TISSUCOL
D.2.1.1.2	Name of the Marketing Authorisation holder	BAXTER, 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	TISSUCOL
D.3.4	Pharmaceutical form	Injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intralesional use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	TISSUCOL
D.3.9.1	CAS number	9002-04-4
D.3.9.2	Current sponsor code	TISSUCOL
D.3.9.3	Other descriptive name	HUMAN THROMBIN
D.3.9.4	EV Substance Code	SUB20551
D.3.10	Strength
D.3.10.1	Concentration unit	% percent
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	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	Yes
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

Anal and criptoglandular fistula

Fístula anal compleja de origen criptoglandular

E.1.1.1

Medical condition in easily understood language

Although most fistulas are simple and can be solved easily fewer cases of them are complex, since it must preserve continence, while eradicates the suppurative process

Aunque la mayoría de las fístulas son simples un menor número de ellas son complejas, constituyendo un reto puesto que debe preservarse la continencia, a la vez que erradica el proceso supurativo

E.1.1.2

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

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 evaluate the efficacy and safety of PRGF as sealant for the treatment of anal fistula cryptoglandular against fibrin, which is the current gold standard treatment for sealing anal fistulas.

Evaluar la eficacia y seguridad de PRFG como agente sellante para el tratamiento de la fístula anal de origen criptoglandular frente a la de fibrina, que es el tratamiento gold stándard actual para el sellado de las fístulas anales.

E.2.2

Secondary objectives of the trial

- To assess the clinical response are wholly or partially, at each visit and at the end of the trial, compared to baseline data.
- Assess the time to clinical remission wholly or partially defined at each visit and at the end of the trial, compared to baseline data.
- To assess the radiological response by endoanal ultrasound at the end of the trial compared to baseline ultrasound data.
- Assess changes in quality of life, assessed using the Quality of Life Questionnaire SF36 at each visit and at the end of the trial, compared to baseline data.
Safety evaluation

- Evaluar la respuesta clínica ?total o parcial-, en cada visita y a la finalización del ensayo, respecto a los datos basales.
- Evaluar el tiempo hasta la remisión clínica ?total o parcial- definida en cada visita y a la finalización del ensayo, respecto a los datos basales.
- Evaluar la respuesta radiológica mediante ecografía endoanal al final del ensayo respecto a los datos ecográficos basales.
- Evaluar las variaciones de la calidad de vida, valorada mediante el Cuestionario de calidad de vida SF36 en cada visita y a la finalización del ensayo, respecto a los datos basales.
La evaluación de la seguridad

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Signed consent
Older than 18 years
Cryptoglandular anal fistulas. There may be at most 3 external orifices open and a maximum one inner hole.

Firma de consentimiento
Edad mayor de 18 años
Fístulas anales de origen criptoglandular. Pueden existir como máximo 3 orificios externos abiertos y como máximo 1 orificio interno.

E.4

Principal exclusion criteria

Filed or coexisting undrained collections.
ASA IV
History of radiation therapy in the perineal area
No internal opening
Pregnant (IF POSSIBLE PREGNANCY PREGNANCY TEST DO)
immunosuppression
Patients with active neoplasia or neoplasia has had a less than a year.
HIV
Simple fistula (submucosal / subcutaneous / low intersphincteric)

Colecciones interpuestas o coexistentes no drenadas.
ASA IV
Antecedentes de radioterapia en la zona perineal
No localización del orificio interno
Embarazadas (SI HAY POSIBILIDAD DE EMBARAZO HACER TEST DE GESTACIÓN)
Inmunodepresión
Pacientes con neoplasia activa o que haya tenido una neoplasia hace menos de un año.
HIV
Fístula simples (submucosas/subcutáneas/interesfinterianas bajas)

E.5 End points

E.5.1

Primary end point(s)

The fistula is considered cured when the external fistula orifice, are closed and / or does not drain after compression finger. Persistence of symptoms after three months of surgery: recurrence and / or failure of treatment is considered.

La Fístula se considera curada cuando el orificio fistuloso externo, esta cerrado y/o no drena, tras compresión con dedo. Se considera recurrencia y/o fracaso de tratamiento: persistencia de síntomas después de tres meses de la cirugía.

E.5.1.1

Timepoint(s) of evaluation of this end point

At three, six, and twelve months after treatment

A los 3, 6 y 12 meses post tratamiento

E.5.2

Secondary end point(s)

The safety assessment will be part of the secondary endpoints and include possible adverse events PRGF measured by recording adverse events reported during the study and clinical findings of the physical examination. The evaluation will also consider the evaluation of fecal incontinence.

La evaluación de la seguridad formará parte de los criterios de valoración secundarios e incluirá los posibles acontecimientos adversos de PRFG, medida mediante el registro de los acontecimientos adversos notificados durante el estudio y los hallazgos clínicos de la exploración física. En dicha evaluación se considerará también la valoración de incontinencia fecal.

E.5.2.1

Timepoint(s) of evaluation of this end point

At three, six, and twelve months after treatment

A los 3, 6 y 12 meses post tratamiento

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

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)

Yes

E.8.2.2

Placebo

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

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

complete cure, defined as 1 year after discharge or no stained by OFE and this is completely re-epithelized. A partial cure when within 1 year after the seal has not stained by oozing or OFE, but it is completely re-epithelized NO.
The primary efficacy was measured at each follow-up period (1, 3, 6 months), the secondary efficacy measure after one year follow-up after treatment

curación completa, se define cuando al cabo de 1 año no presenta supuración ni manchado por el OFE y este se encuentra totalmente reepitelizado. Un curación parcial cuando al cabo de 1 año posterior al sellado no presenta supuración ni manchado por el OFE, pero el éste NO se encuentra totalmente reepitelizado.
La eficacia primaria se medirá en cada periodo de seguimiento (1, 3, 6 meses), la eficacia secundaria se medirá al cabo de un año de seguimiento tras tratamiento

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:

104

F.1.3

Elderly (>=65 years)

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

104

F.4.2

For a multinational trial

F.4.2.1

In the EEA

104

F.4.2.2

In the whole clinical trial

104

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)

Monitoring and control by surgery to see if the fistula again recidivarse
According to clinical practice

Seguimiento y control por parte de cirugía para ver si vuelve a recidivarse la fístula
Según práctica clínica habitual

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

2014-12-09

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2014-06-02

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

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