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    The EU Clinical Trials Register currently displays   43881   clinical trials with a EudraCT protocol, of which   7295   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2011-000905-30
    Sponsor's Protocol Code Number:REM-TEN-2011-01
    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:2012-01-24
    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.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2011-000905-30
    A.3Full title of the trial
    CLINICAL TRIAL WITH PROPHYLACTIC TENOFOVIR FOR HAEMATOLOGICAL CANCER PATIENTS SHOWING A HBc-Ab POSITIVE AND HBs-Ag PATTERN AND TO BE TREATED WITH RITUXIMAB (PREBLIN STUDY)
    ENSAYO CLÍNICO DE TENOFOVIR EN PROFILAXIS DE PACIENTES HEMATOLÓGICOS ANTI-HBc POSITIVO Y AgHBs NEGATIVO EN TRATAMIENTO CON RITUXIMAB (Estudio PREBLIN)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    CLINICAL TRIAL WITH PROPHYLACTIC TENOFOVIR FOR HAEMATOLOGICAL CANCER PATIENTS SHOWING A HBc-Ab POSITIVE AND HBs-Ag PATTERN AND TO BE TREATED WITH RITUXIMAB (PREBLIN STUDY)
    ENSAYO CLÍNICO DE TENOFOVIR EN PROFILAXIS DE PACIENTES HEMATOLÓGICOS ANTI-HBc POSITIVO Y AgHBs NEGATIVO EN TRATAMIENTO CON RITUXIMAB (Estudio PREBLIN)
    A.3.2Name or abbreviated title of the trial where available
    PREBLIN
    A.4.1Sponsor's protocol code numberREM-TEN-2011-01
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorRafael Esteban Mur
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportGilead Sciences, Inc.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPharmacoeconomics & Outcomes Research Iberia
    B.5.2Functional name of contact pointPORIB
    B.5.3 Address:
    B.5.3.1Street AddressCalle Segundo Mata 1 2ª plata oficina 16
    B.5.3.2Town/ cityPozuelo de Alarcón
    B.5.3.3Post code28224
    B.5.3.4CountrySpain
    B.5.4Telephone number34917159147
    B.5.5Fax number34917159469
    B.5.6E-mailMA_casado@porib.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name VIREAD
    D.2.1.1.2Name of the Marketing Authorisation holderGilead Sciences, Inc.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameVIREAD
    D.3.2Product code J05AF07
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTENOFOVIR DISOPROXIL FUMARATO
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another 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.1.1Medical condition(s) being investigated
    CHRONIC HEPATITIS B
    HEPATITIS CRÓNICA B
    E.1.1.1Medical condition in easily understood language
    CHRONIC HEPATITIS B
    HEPATITIS CRÓNICA B
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10008910
    E.1.2Term Chronic hepatitis B
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To compare in HBcAb- positive and HBsAg-negative haematological cancer patients, the prophylactic use of TDF versus observation assessed as the percentage of patients who experienced HBV reactivation (seroreversion or reappearance of the HBsAg) in plasma and/or an increase of HBV DNA levels ≥ 1 log10 IU/mL compared with the baseline value during the 18 months after the starting of treatment with rituximab
    • Comparar, en pacientes hematológicos Anti-HBc positivo y AgHBs negativo, el tratamiento antiviral profiláctico con TDF versus observación, para evaluar el porcentaje de pacientes que sufren una reactivación del VHB (seroreversión: reaparición del antígeno de superficie, AgHBs positivo, y/o elevación de la carga viral ≥ 1 log10 IU/ml sobre la lectura basal) durante los 18 meses posteriores al inicio del tratamiento con rituximab.
    E.2.2Secondary objectives of the trial
    •To asses the proportions of patients in each treatment group that experience reactivation of the VHB during the trial. Patients were considered to experience reactivation of the VHB when they satisfied at least on e of the following criteria:
    Seroreversion: reappearance of the surface antigen (HBsAg) in plasma
    An elevation of HBV DNA levels ≥ 10-fold compared with the baseline value
    •To asses the incidence of hepatitis and liver failure or decompensation
    •To asses overall survival of patients
    •To asses the proportion of patients that discontinued the trial due to adverse clinical reactions or laboratory abnormalities related to TDF.
    • Evaluación de la proporción de pacientes que muestran una reactivación del VHB durante toda su participación en el estudio, definiendo la reactivación por 2 criterios opcionales
    -Seroreversión: reaparición del antígeno de superficie (AgHBs positivo)
    - Elevación de la carga viral: ≥ 1 log10 (IU/ml) sobre la lectura basal
    • Evaluar la incidencia de hepatitis, fallo o descompensación hepáticos.
    • Evaluar la supervivencia global de los pacientes.
    • Evaluar la proporción de pacientes que debe abandonar el estudio por acontecimientos adversos clínicos o por anomalías de laboratorio relacionados con TDF.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Male and female patients over 18 years of age
    •Patients diagnosed with haematological cancer scheduled to receive treatment with rituximab alone or in combination with other chemotherapy
    •Evidence of previous exposure to HBV: HBcAb-positive patients
    •HBsAg negative patients
    •Signed Informed consent
    • Varones o mujeres, mayores de 18 años.
    • Pacientes con diagnóstico de neoplasia hematológica que van a recibir tratamiento con rituximab en monoterapia o en combinación con quimioterapia
    • Evidencia serológica previa de exposición al VHB: anticuerpo anticore (Anti-HBc) positivo.
    • Antígeno de superficie (AgHBs) negativo.
    • Consentimiento informado firmado.
    E.4Principal exclusion criteria
    • Intolerance to any treatment component.
    • Co-infection with HIV.
    • Presence of hepatocellular carcinoma
    • Patients with severe or moderate renal failure
    • Liver or kidney transplant or severe renal, lung or neurological diseases that under investigator criteria may interfere in the patient’s participation during the clinical trial.
    • Pregnancy or breastfeeding.
    • Treatment within the last 30 days with any experimental (non-authorised) drug.
    • Any other disease or condition that might render the patient ineligible for the trial.
    • Intolerancia a alguno de los componentes del régimen terapéutico.
    • Coinfección con VIH.
    • Pacientes con insuficiencia renal grave o moderada
    • Presencia de carcinoma hepatocelular.
    • Enfermedades renales, pulmonares o neurológicas graves que pudieran interferir en la participación del paciente en el estudio.
    • Mujeres embarazadas o en período de lactancia.
    • Tratamiento con cualquier medicamento en investigación (no aprobado) durante los últimos 30 días.
    Cualquier otro trastorno que, en opinión del investigador, haga al paciente inapropiado para su reclutamiento o que pueda interferir en su participación y en la conclusión del estudio
    E.5 End points
    E.5.1Primary end point(s)
    • Proportion of patients that experience a reactivation of HBV after 18 months of treatment with rituximab. Patients were considered to experience reactivation of the VHB when they satisfied at least on e of the following criteria:
    - Seroreversion: reappearance of the surface antigen (HBsAg) in plasma
    - An elevation of HBV DNA levels ≥ 10 log10 IU/mL compared with the baseline value
    *Viral load will be determined preferably through ADN-VHB COBAS Ampliprep Taqman HBV. Hospitals without access to this technique will use the quantification methods ordinarily used in their hospital in clinical practice: COBAS-Amplicor HBV Monitor Test; Roche Diagnostics, PCR assay (LightCycler – FastStart DNA Master, Roche Diagnostic, Mannheim, Germany) or any other
    • Evaluación de la proporción de pacientes que muestran una reactivación del VHB durante los 18 meses posteriores al inicio de tratamiento con rituximab, definiendo la reactivación por 2 criterios opcionales (uno, otro o los dos)
    o Seroreversión: reaparición del antígeno de superficie (AgHBs positivo)
    o Elevación de la carga viral: ≥ 1 log10 (IU/ml) sobre la lectura basal
    Las determinaciones de la carga viral (niveles de ADN-VHB) se llevarán a cabo preferentemente mediante la técnica cuantitativa de detección de ADN-VHB COBAS Ampliprep Taqman HBV, con un límite de detección (LDD) de 3,4 UI/ml.
    Sin embargo, en caso de no utilizarse en los centros la técnica descrita anteriormente, las determinaciones de la carga viral (niveles de ADN-VHB) se llevarán a cabo mediante la técnica cuantitativa de detección de ADN-VHB que se utilice en la práctica clínica habitual en cada uno de los centros participantes:
    - COBAS-Amplicor HBV Monitor Test; Roche Diagnostics, con un LDD de 40 UI/ml.
    - PCR assay (LightCycler – FastStart DNA Master, Roche Diagnostic, Mannheim, Germany) con un LDD de 200 UI/ml.
    E.5.1.1Timepoint(s) of evaluation of this end point
    • After 18 months of treatment with rituximab
    • Tras 18 meses de tratamiento con rituximab
    E.5.2Secondary end point(s)
    •Proportion of patients in the three groups of treatment that have experienced a HBV reactivation during the clinical trial. Patients were considered to experience reactivation of the VHB when they satisfied at least one of the following criteria:
    - Seroreversion: reappearance of the surface antigen (HBsAg) in plasma
    - An elevation of HBV DNA levels ≥ 10 log10 IU/mL compared with the baseline value
    • Incidence of hepatitis and liver failure or decompensation
    • HBsAg titers in the different treatment groups (when available)
    • Overall patient-survival
    • Safety evaluation (adverse reaction and renal function parameters) in the different treatment groups.
    • Evaluación de la proporción de pacientes que muestran una reactivación del VHB en los tres grupos de tratamiento durante toda su participación en el estudio, definiendo la reactivación por 2 criterios opcionales (uno, otro o los dos)
    -Seroreversión: reaparición del antígeno de superficie (AgHBs positivo)
    -Elevación de la carga viral: ≥ 1 log10 (IU/ml) sobre la lectura basal
    • Evaluación de la incidencia de hepatitis, fallo o descompensación hepáticos, relacionadas con la infección por el VHB.
    • Evaluación del título de AgHBs en los diferentes grupos de tratamiento (cuando se disponga de la técnica de cuantificación).
    • Evaluación de la supervivencia global de los pacientes.
    • Evaluación de la seguridad (efectos adversos, parámetros de función renal) en los grupos de tratamiento y para el fármaco en estudio.
    E.5.2.1Timepoint(s) of evaluation of this end point
    • After 2,4,6,8,10,12,14 y 16 months of treatment with rituximab
    • After 18 months of treatment with rituximab
    • After 18 months of treatment with rituximab
    • After 18 months of treatment with rituximab
    • After 18 months of treatment with rituximab
    • Tras 2,4,6,8,10,12,14 y 16 meses de tratamiento con rituximab
    • Tras 18 meses de tratamiento con rituximab
    • Tras 18 meses de tratamiento con rituximab
    • Tras 18 meses de tratamiento con rituximab
    • Tras 18 meses de tratamiento con rituximab
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    NO INTERVENCIÓN
    OBSERVATION
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned17
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    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 trial will coincide with the date of the last scheduled visit of the last recruited patient.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months7
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 95
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 3
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state98
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 98
    F.4.2.2In the whole clinical trial 98
    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)
    the expected normal treatment of that condition
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2011-07-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-05-06
    P. End of Trial
    P.End of Trial StatusCompleted
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