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    EudraCT Number:2019-001441-40
    Sponsor's Protocol Code Number:SC-Ta1-CF-001
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-05-24
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2019-001441-40
    A.3Full title of the trial
    A phase II trial to assess the activity and tolerability of Thymosin alpha 1 in Cystic Fibrosis Patients.
    Studio di Fase II per determinare l’attività e la tollerabilità di Timosina alfa 1 in pazienti con Fibrosi Cistica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of the use of the drug Thymosin alpha 1 in adults patients with Cystic Fibrosis.
    Studio dell'utilizzo del farmaco Timosina alfa-1 in pazienti adulti affetti da fibrosi cistica (FC).
    A.3.2Name or abbreviated title of the trial where available
    Thymosin alpha 1 in Cystic Fibrosis patients
    Timosina alpha 1 in Pazienti con Fibrosi Cistica
    A.4.1Sponsor's protocol code numberSC-Ta1-CF-001
    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 SponsorSciClone Pharmaceuticals Limited Ltd
    B.1.3.4CountryCayman Islands
    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 support
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedi Service S.r.l
    B.5.2Functional name of contact pointCRO
    B.5.3 Address:
    B.5.3.1Street AddressVia G. Matteotti 43/B
    B.5.3.2Town/ cityAgrate Brianza
    B.5.3.3Post code20864
    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.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameZadaxin
    D.3.2Product code [Ta1]
    D.3.4Pharmaceutical form Lyophilisate 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.3.9.1CAS number 62304-98-7
    D.3.9.2Current sponsor codeTa1
    D.3.9.3Other descriptive nameThymosin alpha 1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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. cell therapy medicinal product Information not present in EudraCT
    D. therapy medical product Information not present in EudraCT
    D. Engineered Product Information not present in EudraCT
    D. ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D. on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 Yes
    D. medicinal product typeImmunostimolante
    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
    Fibrosi Cistica
    E.1.1.1Medical condition in easily understood language
    Cystic Fibrosis
    Fibrosi Cistica
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10011762
    E.1.2Term Cystic fibrosis
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level SOC
    E.1.2Classification code 10021881
    E.1.2Term Infections and infestations
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The evaluation of the activity of Thymosin alpha 1 in patients with cystic fibrosis (CF) by means of variation of inflammatory cytokines (IL-1ß, IL-8, IL-17A, IL-6 and TNF-alpha) in serum and induced sputum.
    L’attività di Timosina alfa 1 sarà valutata tramite la variazione media delle citochine infiammatorie IL-1ß, IL-8, IL-17A, IL-6 and TNF-alfa nel siero e nello sputo indotto.
    E.2.2Secondary objectives of the trial
    - Evaluate the safety and tolerability of Thymosin alpha 1 by means of type, incidence, severity, timing, seriousness and relatedness of reported AEs, physical examinations, ECG and laboratory tests.

    - Evaluate the variation of neutrophil elastase in induced sputum, of c-reactive protein in blood and of sweat chloride concentration.

    - Evaluate and compare the first efficacy results about Thymosin alpha1 as assessed by changes before and after the treatment in lung functionality and quality of life.
    - Valutazione della sicurezza e della tollerabilità di Timosina alfa 1 tramite descrizione del tipo, dell’incidenza, della gravità, della correlazione temporale e causalità delle segnalazioni degli Eventi Avversi, esame obiettivo, ECG e test di laboratorio.

    - Valutazione dell’elastasi neutrofila nello sputo indotto, della proteina C reattiva nel sangue e delle concentrazioni di cloro nel sudore.

    - Valutazione dei primi risultati di efficacia di Timosina alfa1 come determinazione, prima e dopo il trattamento, della funzionalità polmonare e della qualità della vita del paziente.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Male or female, from 18 years of age (inclusive) at the time of screening.
    • Signed Informed Consent.
    • Confirmed diagnosis of CF, based on the following: two sweat chloride tests with a result = 60 mEq/L or two CFTR mutations on genetic test.
    • CF diagnosis independently of genetic mutations.
    • Clinical stability with no change in symptoms and/or medication within 4 weeks prior to screening.
    • Body mass index (BMI) = 15.0 (kg/m2).
    • Non-tobacco/nicotine-containing product user for a minimum of 6 months prior to screening.
    • Percent Predicted Forced Expiratory Volume (ppFEV1) > 40%, predicted at screening.
    • Female with pregnancy test negative and using an acceptable contraception method, except if postmenopausal for more than 2 years or sterilized for more than 3 months.
    • Blood pressure: DBP values between 60 and 89 mmHg, and SBP values between 90 and 139 mmHg. ECG normal or wave changes not considered clinically significant.
    • Pulse betweem 50 and 120 bpm unless deemed clinically. insignificant by the PI.
    • Maschi e Femmine di età = 18 anni
    • Firma del consenso informato.
    • Diagnosi confermata di Fibrosi Cistica basata su due test della concentrazione di cloro nel sudore con risultato = 60 mEq/L o due mutazioni di CFTR evidenziate da test genetico.
    • Diagnosi di Fibrosi Cistica indipendentemente dalla mutazione genetica.
    • Stabilità clinica con nessuna variazione dei sintomi e della terapia nelle 4 settimane antecedenti l’arruolamento
    • Indice di massa corporea = 15.0 (kg/m2).
    • Nessun utilizzo di prodotti contenenti tabacco/nicotina nei 6 mesi antecedenti l’arruolamento.
    • Volume espiratorio massimo nel primo secondo (FEV1) > 40% allo screening.
    • Test di gravidanza (per pazienti di sesso femminile) negativo ed utilizzo di un adeguato metodo di contraccezione, eccetto per pazienti in menopausa per più di due anni o sterilizzate da più di 3 mesi.
    • Pressione diastolica tra i 60 e gli 89, pressione sistolica tra i 90 e i 139. Valori di ECG normali o ritenuti non clinicamente significativi dal P.I
    • Battito tra 50 e i 120 bpm a meno che ritenuto non clinicamente significativo dal P.I.
    E.4Principal exclusion criteria
    • Clinical/laboratory/radiological/spirometric signs of unstable or unexpectedly deteriorating respiratory disease (30 days prior to the screening).
    • Any malignancy or chronic organ failure or disease that depart from the patient's usual baseline level of health as a patient with CF.
    • Patients with “F508del homozygous mutation” treated successfully with corrector potentiators, according to physicians’ judgment.
    • Intravenous antibiotic use in the last 4 weeks before screening.
    • Treatment with oxygen.
    • History of organ or hematological transplantation.
    • Kidney (creatinine 2-fold of the normal upper limit) or hepatic alterations (Child Pugh score equal to B or C).
    • History or presence of alcoholism or drug abuse within 2 years prior to the screening.
    • Personal or family history of prolonged QT syndrome; or a QTc interval >430 msec (males) or > 450 msec (females) using Bazett's formula (QTcB) or deemed clinically significant by the PI.
    • In the judgment of the PI, clinically significant hemoptysis (>30 ml per episode) within the last 180 days.
    • History of allergy, hypersensitivity, intolerance to Thymosin alpha1 and to its excipients (Mannitol, monobasic sodium phosphate monohydrate, dibasic sodium phosphate heptahydrate)
    • Ongoing or prior participation in an investigational drug study within 30 days of screening.
    • Parametri Clinici, di laboratorio, radiologici o spirometrici di instabilità o deterioramento respiratorio inatteso nei 30 giorni antecedenti la prima somministrazione di farmaco sperimentale.
    • Presenza di malattia tumorale oppure deterioramento cronico di organi, significativamente diverso dal quadro generale di salute del soggetto con Fibrosi Cistica.
    • Pazienti con mutazione F508del in omozigosi, trattati in modo soddisfacente con correttori/potenziatori, a giudizio del P.I.
    • Uso di antibiotici per i.v nelle 4 settimane antecedenti l’arruolamento.
    • Trattamento con ossigeno.
    • Presenza in storia medica di trapianti di organi o ematologici.
    • Alterazione renale (creatinina più di 2 volte il valore limite superiore) o epatica (Child Pugh B o C).
    • Anamnesi o presenza di alcolismo o abuso di farmaci nei 2 anni antecedenti la prima somministrazione di farmaco sperimentale.
    • Anamnesi personale o famigliare del prolungamento del tratto QT; oppure un intervallo QTc >430 msec (maschi) o >450 msec (femmine) utilizzando la formula di Bazett's (QTcB) oppure giudicato clinicamente significativo dallo sperimentatore
    • A giudizio dello sperimentatore, una epistassi clinicamente significativa (>30 cc per episodio) negli ultimi 180 giorni
    • Storia di allergie, ipersensibilità, intolleranza al principio attivo Timosina alfa 1 e ai suoi eccipienti (mannitolo,
    sodio fosfato monobasico monoidrato, sodio fosfato bibasico eptaidrato)
    • Partecipazione a studi clinici con farmaci sperimentali nei 30 giorni antecedenti lo screening o attualmente in corso.
    E.5 End points
    E.5.1Primary end point(s)
    The activity of Thymosin alpha 1 will be evaluated by means of variation of inflammatory cytokines (IL-1ß, IL-8, IL-17A, IL-6 and TNF-alpha) in serum and induced sputum,
    L’attività della Timosina alfa 1 sarà valutata tramite la variazione media delle citochine infiammatorie IL-1ß, IL-8, IL-17A, IL-6 and TNF-alfa nel siero e nello sputo indotto.
    E.5.1.1Timepoint(s) of evaluation of this end point
    It will be considered the difference between the values at the end of the first treatment period (week 8) and those at the baseline.
    Verrà considerata la differenza tra i valori al basale (reclutamento) e quelli alla fine del primo periodo di trattamento (8° settimana).
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    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. trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 No
    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.8.2.4Number of treatment arms in the trial1
    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.8.4.1Number of sites anticipated in Member State concerned1
    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 Information not present in EudraCT
    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
    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 months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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: 24
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1
    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 state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 24
    F.4.2.2In the whole clinical trial 24
    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)
    Patients after taking the two doses of drug (in the first sixteen weeks), enter an observation period (Follow up) for a further 8 weeks, in which they will not receive treatment, but any adverse events will be evaluated, in addition to the functionality of the treatment. Patients who will be involved in the study will be patients already being treated at the center and once the study is completed, they will continue to be followed by the center according to the best clinical practice
    I pazienti dopo aver assunto le due dosi di farmaco (nelle prime sedici settimane), entrano in un periodo di osservazione (Follow up) per ulteriori 8 settimane, nel quale non riceveranno il trattamento, ma saranno valutati eventuali eventi avversi, oltre alla funzionalità del trattamento. I pazienti che verranno coinvolti nello studio saranno pazienti già in cura presso il centro e una volta concluso lo studio , continueranno ad essere seguiti dal centro secondo la migliore pratica clinica.
    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 Decision2019-11-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-12-17
    P. End of Trial
    P.End of Trial StatusOngoing
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    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
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