Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2020-005513-41
    Sponsor's Protocol Code Number:TA799-012
    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:2021-08-05
    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
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2020-005513-41
    A.3Full title of the trial
    An open-label extension trial to evaluate the long-term safety of apraglutide in short bowel syndrome
    Estudio de prolongación sin enmascaramiento para evaluar la seguridad a largo plazo de apraglutida en el síndrome de intestino corto
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Long-term safety of apraglutide in short bowel syndrome
    Estudio para evaluar la seguridad a largo plazo de apraglutida en el síndrome de intestino corto
    A.4.1Sponsor's protocol code numberTA799-012
    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 SponsorVectivBio AG
    B.1.3.4CountrySwitzerland
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportVectivBio AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVectivBio AG
    B.5.2Functional name of contact pointClinical Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street AddressAeschenvorstadt 36
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4051
    B.5.3.4CountrySwitzerland
    B.5.5Fax number+4144 660 6590
    B.5.6E-mailclinicaltrial.enquiries@vectivbio.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 No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/18/2102
    D.3 Description of the IMP
    D.3.1Product nameapraglutide
    D.3.2Product code TA799
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAPRAGLUTIDE
    D.3.9.1CAS number 1295353-98-8
    D.3.9.2Current sponsor codeTA799; FE 203799
    D.3.9.3Other descriptive nameapraglutide
    D.3.9.4EV Substance CodeSUB193006
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    short bowel syndrome
    síndrome de intestino corto
    E.1.1.1Medical condition in easily understood language
    short gut
    intestino corto
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10049416
    E.1.2Term Short-bowel syndrome
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess long-term safety and tolerability of apraglutide in subjects with SBS-IF
    Evaluar la seguridad y la tolerabilidad a largo plazo de apraglutida en pacientes con SIC-FI
    E.2.2Secondary objectives of the trial
    To evaluate markers indicative of clinical effects of apraglutide
    Evaluar marcadores indicativos de los efectos clínicos de apraglutida
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Males and females with a diagnosis of SBS-IF secondary to surgical resection of the small intestine, with CIC or stoma, who have completed parent trials TA799-007 or TA799-013 and:
    a. Did not meet any stopping criteria.
    b. Received a minimum of 70% of the planned doses in the trial (unless an AE precluded the subject from meeting this percentage; in this case, the Investigator will decide if the subject will benefit from enrolling in the trial).
    c. Complete the last two scheduled visits of the parent trial. Subjects who were forced to withdraw from TA799-007 for logistical reasons not related to the efficacy or safety of apraglutide (e.g., hospitalization for a car accident, COVID-19 pandemic, or emergency surgery) which resulted in several consecutive missed doses may be eligible to participate in this trial upon approval by the Medical Monitor.
    2. Able to give informed consent and agree to follow the details of participation as outlined in this protocol.
    3. Women of childbearing potential must agree to use a highly effective method of contraception during the trial and for 4 weeks after the end of trial (EOT) visit.
    4. Male subjects with a female partner of childbearing potential must commit to practice methods of contraception and abstain from sperm donation during the trial and for 2 weeks after the EOT Visit.
    1. Pacientes de ambos sexos con diagnóstico de SIC-FI secundario a una resección quirúrgica del intestino delgado, con CEC o estoma, que hayan completado los estudios originarios TA799-007 o TA799-013 y que:
    a. No cumplan ninguno de los criterios de interrupción.
    b. Hayan recibido al menos el 70 % de las dosis programadas en el estudio (a menos que un AA hubiera impedido al paciente cumplir este porcentaje; en este caso, el investigador decidirá si el reclutamiento en el estudio puede ser beneficioso para el paciente).
    c. Hayan completado las dos últimas visitas programadas del estudio originario. En el caso de los pacientes que tuvieron que retirarse del estudio TA799-007 por razones logísticas no relacionadas con la eficacia o la seguridad de apraglutida (por ejemplo, por una hospitalización por un accidente de coche, la pandemia de la COVID-19 o una cirugía de urgencia) y que por ello dejaron de recibir varias dosis consecutivas, pueden ser elegibles para participar en este estudio, previa aprobación del monitor médico.
    2. Ser capaz de proporcionar el consentimiento informado y estar de acuerdo en seguir los detalles de participación según se define en este protocolo.
    3. Las mujeres que puedan quedarse embarazadas deben comprometerse a utilizar un método anticonceptivo muy eficaz durante el estudio y las 4 semanas posteriores a la visita correspondiente al final de este (final del estudio [FDE]).
    4. Los pacientes varones con una pareja que pueda quedarse embarazada deben comprometerse a utilizar métodos anticonceptivos y abstenerse de donar esperma durante el estudio y las 2 semanas posteriores a la visita del FDE.
    E.4Principal exclusion criteria
    1. Subject not capable of understanding or not willing to adhere to the trial visit schedules and other protocol requirements.
    2. Any other reason judged not eligible by the Investigator.
    1. Pacientes que no puedan comprender o no estén dispuestos a cumplir los calendarios de visitas del estudio y otros requisitos del protocolo.
    2. Cualquier otra razón que el investigador considere que haga que el paciente no sea elegible.
    E.5 End points
    E.5.1Primary end point(s)
    - Adverse events (AE; system organ class, frequency and severity)
    - Occurrence of clinically relevant AEs of special interest (AESIs):
    o Injection site reactions
    o Gastrointestinal (GI) obstructions
    o Gallbladder, biliary and pancreatic disease
    o Fluid overload
    o Colorectal polyps
    o Malignancies
    - Clinical chemistry, hematology, hemostasis and urinalysis
    - Occurrence of clinically relevant changes in vital signs (systolic and diastolic blood pressure, heart rate)
    - Occurrence of clinically relevant changes in electrocardiogram (ECG; intervals and rhythm)
    - Acontecimientos adversos (AA; sistema, órgano y clase; frecuencia y gravedad)
    - Incidencia de AA de interés especial (AAIE) clínicamente relevantes:
    o Reacciones en el lugar de inyección
    o Obstrucciones gastrointestinales (GI)
    o Colecistopatía, enfermedad biliar y pancreática
    o Hipervolemia
    o Pólipos colorrectales
    o Neoplasias malignas
    • Bioquímica clínica, hematología, hemostasis y análisis de orina
    • Incidencia de cambios clínicamente relevantes en las constantes vitales (tensión arterial sistólica y diastólica, frecuencia cardíaca)
    • Incidencia de cambios clínicamente relevantes en los electrocardiogramas (ECG; intervalos y ritmo)
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 104
    semana 104
    E.5.2Secondary end point(s)
    - Change from baseline in PS volume at Week 104
    - Change from baseline in PS frequency at Week 104
    - Change from baseline in PS composition at Week 104
    - Change from baseline in PS infusion time at Week 104
    - Percentage of subjects reaching enteral autonomy by Week 104
    - Change from baseline in body weight at Week 104
    - Change from baseline on QoL measures at Week 104
    - Cambio entre el período inicial y la semana 104 en el volumen del AP
    - Cambio entre el período inicial y la semana 104 en la frecuencia del AP
    - Cambio entre el período inicial y la semana 104 en la composición del AP
    - Cambio entre el período inicial y la semana 104 en el tiempo de infusión del AP
    - Porcentaje de pacientes que alcancen la autonomía entérica en la semana 104
    - Cambio entre el período inicial y la semana 104 en el peso corporal
    - Cambio entre el período inicial y la semana 104 en el Índice de la calidad del sueño de Pittsburgh (PSQI)
    - Cambio entre el período inicial y la semana 104 en la Impresión global del cambio percibido por el paciente (PGIC)
    - Cambio entre el período inicial y la semana 104 en la Impresión global de la gravedad percibida por el paciente (PGIS)
    E.5.2.1Timepoint(s) of evaluation of this end point
    week 104
    semana 104
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA26
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    China
    Israel
    Japan
    Korea, Republic of
    Taiwan
    United States
    Belgium
    Denmark
    France
    Germany
    Italy
    Norway
    Poland
    Spain
    Sweden
    United Kingdom
    Czechia
    Argentina
    E.8.7Trial 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
    LVLS
    ultima visita del ultimo paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    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 No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 84
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 70
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 72
    F.4.2.2In the whole clinical trial 154
    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
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-11-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-10-29
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sun May 19 14:20:59 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA