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    The EU Clinical Trials Register currently displays   42319   clinical trials with a EudraCT protocol, of which   6970   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2020-005224-12
    Sponsor's Protocol Code Number:KAFTAC2020
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-01-04
    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
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedNetherlands - Competent Authority
    A.2EudraCT number2020-005224-12
    A.3Full title of the trial
    Elexacaftor/tezacaftor/ivacaftor in patients with cystic fibrosis using tacrolimus, a drug - drug interaction study
    Elexacaftor/tezacaftor/ivacaftor in patienten met cystic fibrosis die tacrolimus gebruiken, een geneesmiddelen interactie studie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Kaftrio in cystic fibrosis patients currently using tacrolimus, a drug drug interaction study
    Kafrtrio in patienten met taaislijmziekte die tacrolimus gebruiken, een geneesmiddelen interactie studie
    A.3.2Name or abbreviated title of the trial where available
    Kaftac
    A.4.1Sponsor's protocol code numberKAFTAC2020
    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 SponsorHaga Teaching Hospital
    B.1.3.4CountryNetherlands
    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 supportHaga Teaching Hospital
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHaga Teaching Hospital
    B.5.2Functional name of contact pointDept of pulmonology and CF
    B.5.3 Address:
    B.5.3.1Street AddressEls Borst-Eilersplein 275
    B.5.3.2Town/ cityThe Hague
    B.5.3.4CountryNetherlands
    B.5.6E-mailr.vandermeer@hagaziekenhuis.nl
    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 Kaftrio
    D.2.1.1.2Name of the Marketing Authorisation holderVertex Pharmaceuticals
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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/3/18/2116
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.11 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
    cystic fibrosis patients
    E.1.1.1Medical condition in easily understood language
    patients with cystic fibrosis
    E.1.1.2Therapeutic area Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate the pharmacokinetic interaction of elexacaftor/tezacaftor/ivacaftor and tacrolimus in adult CF patients using tacrolimus after renal or liver transplantation by:
    - quantitating the effect of elexacaftor/tezacaftor/ivacaftor on the bioavailability of tacrolimus in CF patients with a history of liver or kidney transplantation and current on tacrolimus treatment.
    - quantitating the dose adjustment of tacrolimus during co-administration of elexacaftor/tezacaftor/ivacaftor.
    E.2.2Secondary objectives of the trial
    - To investigate the clinical effect of elexacaftor/tezacaftor/ivacaftor in CF patients using tacrolimus after renal or liver transplantation.
    - To quantitate the exposure to elexacaftor/tezacafor/ivacaftor in week 1, 2, 3 and 4 after starting elexacaftor/tezacaftor/ivacaftor.
    - To quantitate the number of side effects (adverse events and serious adverse events) when when co-administrating the elexacftor/tezacaftor/ivacaftor with tacrolimus.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Males and females aged 18 years or older on the date of informed consent
    -Diagnosis of cystic fibrosis with a genotype registered for the use of elexacaftor/tezacaftor/ivacaftor confirmed by genotype analysis.
    -Kidney or liver transplantation > 1 year ago
    -Current use of tacrolimus
    -Signed informed consent form (ICF)
    E.4Principal exclusion criteria
    -Use of drugs that are metabolized by the CYP3A enzyme or have a known influence on the CYP3A enzyme (inducers or inhibitors)
    -Having a contra indication for the use of elexacaftor/tezacaftor/ivacaftor
    -Organ rejection within the last 3 months
    -Pulmonary exacerbation within one month before the study period (defined as need for intravenous antibiotics)
    -Pregnancy or lactation
    -Pregnancy wish
    E.5 End points
    E.5.1Primary end point(s)
    - Pharmacokinetic parameters: T1/2, Tmax, Cmax, Cmin, AUC all measured without and with co administration of elexacaftor/tezacaftor/ivacaftor in order to measure RAUC of tacrolimus (RAUC=AUCtacro with elexacaftor/tezacaftor/ivacaftor/AUCtacro) in week 1, 2, 3 and 4 after starting elexacaftor/tezacaftor/ivacaftor. Change in T1/2, Tmax, Cmax, Cmin after co-administration with elexacaftor/tezacaftor/ivacaftor measured in week 1, 2, 3 and 4 after starting elexacaftor/tezacaftor/ivacaftor.
    - Number and level of dose adjustments made in order to stay within target tacrolimus values.
    E.5.1.1Timepoint(s) of evaluation of this end point
    at the end of the study period
    E.5.2Secondary end point(s)
    - Absolute change in lung function (FVC and FEV1), absolute change in quality of life (CFQ), , absolute change in nutritional status (weight, BMI) in week 1, 2, 3 and 4 after starting elexacaftor/tezacaftor/ivacaftor. Absolute change in sweatchloride from baseline through end of the study.
    - Through concentrations of elexacaftor, tezacaftor and ivacaftor measured in week 1, 2, 3 and 4 after starting elexacaftor/tezacaftor/ivacaftor.
    - Safety and tolerability based on the number and type of (S)AEs, laboratory values and vital signs.
    E.5.2.1Timepoint(s) of evaluation of this end point
    at the end of the study period
    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 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 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 Yes
    E.8.1.7.1Other trial design description
    a single centre open label controlled clinical drug-drug interaction trial
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned 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: 5
    F.1.3Elderly (>=65 years) No
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state5
    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)
    kaftrio will be continued if the treating physician and the patients agree.
    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 Decision2021-01-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-05-01
    P. End of Trial
    P.End of Trial StatusOngoing
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