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    The EU Clinical Trials Register currently displays   40635   clinical trials with a EudraCT protocol, of which   6629   are clinical trials conducted with subjects less than 18 years old.
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    EudraCT Number:2018-004318-16
    Sponsor's Protocol Code Number:DAS181-3-01
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2019-11-21
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedDenmark - DHMA
    A.2EudraCT number2018-004318-16
    A.3Full title of the trial
    A Phase III Randomized Placebo-Controlled Study to Examine the Efficacy and Safety of DAS181 for the Treatment of Lower Respiratory Tract Parainfluenza Infection in Immunocompromised Subjects
    Et randomiseret placebokontrolleret fase III-forsøg til undersøgelse af virkningen og sikkerheden af DAS181 til behandling af parainfluenzainfektion i de nedre luftveje hos immunsvækkede forsøgspersoner

    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    STOP PIV - Phase III DAS181 Lower Tract PIV Infection in Immunocompromised Subjects
    Et randomiseret placebokontrolleret fase III-forsøg til undersøgelse af virkningen og sikkerheden af DAS181 til behandling af parainfluenzainfektion i de nedre luftveje hos immunsvækkede forsøgspersoner. For bedre at kunne vurdere virkningsmekanismen af den aktive forsøgsmedicin DAS181, sammenlignes DAS181 med et inaktivt stof (placebo). Hvilken behandling personen skal have afgøres ved tilfældig distribution (randomisering).
    A.3.2Name or abbreviated title of the trial where available
    STOP PIV - Phase III DAS181 Lower Tract PIV Infection in Immunocompromised Subjects
    STOP PIV - fase III DAS181 PIV-infektion i de nedre luftveje hos immunsvækkede forsøgspersoner
    A.4.1Sponsor's protocol code numberDAS181-3-01
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03808922
    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 SponsorAnsun Biopharma, Inc.
    B.1.3.4CountryUnited States
    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 supportAnsun Biopharma, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAnsun Biopharma, Inc.
    B.5.2Functional name of contact pointMedical Monitor
    B.5.3 Address:
    B.5.3.1Street Address3030 Callan Road
    B.5.3.2Town/ citySan Diego
    B.5.3.3Post codeCA 92121
    B.5.3.4CountryUnited States
    B.5.4Telephone number858452 2631218
    B.5.5Fax number858452 0133
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.2Product code DAS181
    D.3.4Pharmaceutical form Inhalation solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFarbefusp
    D.3.9.2Current sponsor codeDAS181
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4.5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 Yes
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInhalation solution
    D.8.4Route of administration of the placeboInhalation use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Treatment of Lower Respiratory Tract Parainfluenza Infection in Immunocompromised Subjects
    E.1.1.1Medical condition in easily understood language
    Parainfluenza virus
    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 HLT
    E.1.2Classification code 10033796
    E.1.2Term Parainfluenzae viral infections
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate the efficacy of DAS181 on clinical outcome as measured by frequency of return to room air (RTRA) responders compared to placebo
    E.2.2Secondary objectives of the trial
    To evaluate the effect of DAS181 on the frequency and rate of return to room air (RTRA) compared to placebo

    To evaluate the effect of DAS181 on mortality (all-cause and pulmonary infection-related) compared to placebo

    To evaluate the effect of DAS181 on the frequency and rate of return to Clinical Stability (CS) compared to placebo

    To evaluate the effect of DAS181 on the length of initial hospital stay and of total days of hospitalization compared to placebo

    To evaluate the effect of DAS181 on pulmonary function compared to placebo
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    1. Main/Parent Optional Pharmacokinetics Sub-Study Information Sheet
    and Consent Form, version 2.0 dated 21Feb2019.

    2. Pediatric Pharmacokinetic Sub-Study Assent Form (12–17 Years Old) Assent of a Minor to Be in an Investigational Study, version 2.0 dated 21Feb2019.

    Objective is to investigate how the study drug is processed by the body by checking how much of the study drug is in the bloodstream at a particular point in time.
    E.3Principal inclusion criteria
    Subjects must meet all of the following inclusion criteria to be eligible for participation in this study:
    1. Requires, at the time of randomization, supplemental oxygen ≥2 LPM due to hypoxemia, defined by meeting at least one of the following criteria:
    - SpO2 <92% on or off supplemental oxygen
    - mechanical or non-invasive ventilation (CPAP or Bi-PAP)
    - Written declaration from Investigator that subject is clinically hypoxemic and removal of oxygen supplementation would not be considered clinically appropriate for the purpose of measuring SpO2 while on room air
    Note: Documentation of hypoxemia prior to or during the most recent oxygen supplementation must be available in source documents.
    Note: Subjects who also require invasive mechanical ventilation (MV) or non-invasive positive pressure ventilation (CPAP or bi-PAP) are eligible, although ventilator support is not mandatory
    2. Immunocompromised, as defined by one or more of the following:
    - Received an autologous or allogeneic hematopoietic stem cell transplantation (HSCT) at any time in the past
    - Received a solid organ transplant at any time in the past
    - Has been or is currently being treated with chemotherapy for hematologic malignancies (e.g., leukemia, myeloma, lymphoma) and/or solid tumor malignancies (e.g., lung, breast, brain cancer) at any time in the past
    - Has an immunodeficiency due to congenital abnormality (only applicable to subjects age < 18 years old) or pre-term birth (only applicable to subjects age ≤ 2 years old)
    3. Has, within 3 days prior to randomization, a confirmed LRTI with a sialic acid dependent respiratory virus (SAD-RV, see definition). This can be confirmed by:
    - bronchoalveolar lavage (BAL) positive for SAD-RV
    - lung biopsy positive for SAD-RV
    - chest imaging with a new or worsening finding of pulmonary infiltrate, bronchiolitis, or pneumonitis temporally associated with an upper respiratory tract sample (e.g., tracheal aspirate, sputum, nasopharyngeal swab (NPS), nasopharyngeal wash) positive for SAD-RV
    Note: These requirements can be fulfilled by results from samples and/or chest imaging that are collected/performed locally as per standard of care within 3 days prior to randomization.
    Note: For all subjects, after obtaining informed consent but within 3 days prior to randomization, a separate nasopharyngeal swab sample will be collected and sent to the central laboratory for confirmation of a SAD-RV. The results from the central lab analysis are not required to initiate the subject on study treatment.
    4. If female, subject must meet one of the following conditions:
    - Not be of childbearing potential, defined as one or more of the following conditions:
    -Postmenopausal for at least 1 year
    -Surgically sterile due to bilateral tubal ligation, bilateral oophorectomy, or hysterectomy;
    - Be of childbearing potential and meet all of the following criteria:
    -Has a negative urine or serum pregnancy test (beta-human chorionic gonadotropin) at screening
    -Agrees to practice an acceptable method of contraception (or meets criteria for waiving contraception) from screening until at least 30 days after last dose of study medication (see Section 8.10.1) for details)
    Note: Additional contraception requirements may need to be followed according to local regulations and/or requirements.
    5. Non-vasectomized males are required to practice effective birth control methods (see Section 8.10.1) from screening until at least 30 days after last dose of study medication
    6. Capable of understanding and complying with procedures as outlined in the protocol as judged by the Investigator and able to sign informed consent form prior to the initiation of any screening or study-specific procedures. Subjects must have the ability to return to the hospital to comply with required procedures if they are discharged during the study.
    Note: For subjects, including minors and patients with medical incapacity or impaired consciousness such that they are not able to give fully informed voluntary consent, the subjects' legal representative (parent, guardian or surrogate) must sign an institutional review board (IRB)/independent ethical committee (IEC)-approved informed consent document prior to the initiation of any screening or study-specific procedures. Minor subjects must also sign an IRB/IEC-approved assent form unless not required per local and institution regulations
    E.4Principal exclusion criteria
    Subjects who meet any of the following exclusion criteria will not be enrolled in this study:
    1. Subjects may not be on hospice care or, in the opinion of the investigator, have a low chance of survival during the first 10 days of treatment
    2. Subjects with Alanine Aminotransferase (ALT), Aspartate
    Aminotransferase (AST), or Alkaline Phosphatase (ALP) ≥3x ULN and
    Total Bilirubin (TBILI) ≥2x ULN.
    Note: Subjects with ALT/AST/ALP ≥ 3x ULN and TBILI ≥2x ULN that
    have been chronically stable (for >1 year on more than one assessment)
    due to known liver pathology including malignancy (primary or
    metastasis), chronic medications, transplantation, or chronic infection
    will not be excluded
    3. Female subjects breastfeeding or planning to breastfeed at any time
    through 30 days after the last dose of study drug
    4. Subjects taking any other investigational drugs used to treat pulmonary infection.
    5. Psychiatric or cognitive illness or recreational drug/alcohol use that, in the opinion of the principal investigator, would affect subject safety and/or compliance
    6. Subjects with known hypersensitivity to DAS181 and/or any of its components
    7. Subjects with severe sepsis due to either their baseline SAD-RV infection or a concurrent viral, bacterial, or fungal infection and meet at least one of the following criteria:
     Has evidence of vital organ failure outside of the lung (e.g., liver,
    kidney), or
     Requires vasopressors to maintain blood pressure
    E.5 End points
    E.5.1Primary end point(s)
    Percent of subjects who ‘Return to Room Air’ by Day 28
    E.5.1.1Timepoint(s) of evaluation of this end point
    by Day 28
    E.5.2Secondary end point(s)
    a. All-cause mortality rate at Day 28
    b. Percent of subjects who RTRA by Day 21
    c. Time (in days) to RTRA
    d. Percent of subjects who achieve CS by Day 28
    e. Percent of subjects discharged (without mortality or hospice) by Day 14, 21, 28 and 35
    f. Time (in days) to first hospital discharge (without mortality or
    g. Total number of inpatients days (up to Day 35)
    h. Mortality at Day 28 related to baseline SAD-RV infection
    i. Mortality at Day 35 related to baseline SAD-RV infection
    j. All-cause mortality rate at Day 35
    k. Change in pulmonary function (FEV1% predicted) from Day 1 (baseline) to Day 7, Day 14 and Day 28
    E.5.2.1Timepoint(s) of evaluation of this end point
    a. at Day 28
    b. by Day 21
    c. in days
    d. by Day 28
    e. by Day 14,21,28 and 35
    f. in days
    g. up to Day 35
    h. at Day 28
    i. at Day 35
    j. at Day 35
    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 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. 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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA19
    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
    Hong Kong
    Korea, Republic of
    United States
    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
    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 months2
    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 months2
    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 Yes
    F.1.1Number of subjects for this age range: 1
    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) Yes
    F. of subjects for this age range: 1
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F. of subjects for this age range: 1
    F.1.1.5Children (2-11years) Yes
    F. of subjects for this age range: 1
    F.1.1.6Adolescents (12-17 years) Yes
    F. of subjects for this age range: 1
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 85
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 46
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 23
    F.4.2.2In the whole clinical trial 192
    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)
    Treatment as per normal standard of care.
    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 Decision2020-01-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-01-23
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
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