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    The EU Clinical Trials Register currently displays   43876   clinical trials with a EudraCT protocol, of which   7294   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:2020-001966-13
    Sponsor's Protocol Code Number:EDP938-201
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-03-26
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2020-001966-13
    A.3Full title of the trial
    A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 2-PART STUDY TO EVALUATE EDP-938 REGIMENS IN SUBJECTS AGED 28 DAYS TO 36 MONTHS INFECTED WITH RESPIRATORY SYNCYTIAL VIRUS (RSV)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of EDP-938 in subjects aged 28 days to 36 months infected with respiratory syncytial virus (RSV)
    A.3.2Name or abbreviated title of the trial where available
    RSVPEDs
    A.4.1Sponsor's protocol code numberEDP938-201
    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 SponsorEnanta Pharmaceuticals, 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 supportEnanta Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEnanta Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointMaria Gawryl
    B.5.3 Address:
    B.5.3.1Street Address500 Arsenal Street
    B.5.3.2Town/ cityWatertown
    B.5.3.3Post codeMA 02472
    B.5.3.4CountryUnited States
    B.5.4Telephone number+16177443226
    B.5.6E-mailmgawryl@enanta.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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameEDP-938
    D.3.4Pharmaceutical form Powder for oral suspension
    D.3.4.1Specific paediatric formulation Yes
    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 INNnot available
    D.3.9.1CAS number 2070852-76-3
    D.3.9.2Current sponsor codeEDP-938
    D.3.9.3Other descriptive nameEP-023938, EP-3938, EPS-3938, EPC-3938
    D.3.9.4EV Substance CodeSUB214949
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboPowder for oral suspension
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Respiratory Syncytial Virus (RSV)
    E.1.1.1Medical condition in easily understood language
    Respiratory Syncytial Virus (RSV) can infect the lungs and windpipe. The infection could be particularly severe for small children, the elderly and in people with weak immune systems.
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10061603
    E.1.2Term Respiratory syncytial virus infection
    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
    Part 1
    • To evaluate the PK of EDP-938
    • To assess the safety and tolerability of EDP-938
    Part 2
    • To evaluate the antiviral activity of EDP-938
    E.2.2Secondary objectives of the trial
    Part 1
    • To evaluate the antiviral activity of EDP-938
    Part 2
    • To assess the safety and tolerability of EDP-938
    • To evaluate the PK of EDP-938
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female who is either≥6 months to ≤36 months (for Age Group
    1) or ≥28 days to <6 months, (for Age Group 2), defined at the time of randomization (Subjects in Age Group 2 must have been born ≥29 weeks of gestation to be eligible. If a subject was born <29 weeks of gestation the subject can only be enrolled in Age Group 1)
    2. Subjects diagnosed with RSV infection using an approved diagnostic assay, without known and/or documented coinfection with SARS-CoV-2. If RSV infection is not confirmed, caregivers may be asked to sign a RSV Diagnostic Test ICF allowing a rapid antigen RSV test to be performed;
    3. Subjects with signs of an acute respiratory illness (eg, fever [or symptoms of fever], cough, nasal congestion, runny nose, rapid breathing, shortness of breath, or wheezing) with onset ≤7 days before the time of signing the informed consent form (ICF)
    Note: Time of onset of symptoms is defined from the caregiver(s) estimated time of awareness of the first sign of respiratory infection
    4. Have a calculated creatinine clearance rate not below the lower limit of normal (LLN) for the subject’s age as determined by the Schwartz equation (Schwartz & Work, 2009) at Screening
    5. In the Investigator’s opinion, the subject’s caregiver understands and is able to comply with protocol requirements, instructions, and protocol-stated restrictions, and the subject is likely to complete the study as planned
    Additional inclusion criterion for Part 1 Cohort 1, Age Groups 2
    6. Subject is currently or is planned to be hospitalized as a consequence of RSV infection and is not anticipated to be discharged in less than 24 hours after enrollment
    E.4Principal exclusion criteria
    1. Use of or anticipated need for invasive monitoring and associated medical care, eg admission to ICU or equivalent medical setting, requirement for mechanical ventilation, cardiopulmonary bypass, hemodialysis, or extracorporeal membrane oxygenation; or subjects who are not expected to survive the current illness
    2. Subjects who have a medical history or a concurrent illness that in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject, or that could prevent, limit, or confound the protocol-specified assessments. Examples include liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, or metabolic conditions
    3. Subjects who are considered unable to take study drug orally, eg, as a consequence of acute respiratory distress, or unable to absorb study drug enterally
    4. Subjects who have received blood products within 6 months of study drug administration
    5. Subjects with underlying immune deficiency, eg, from confirmed human immunodeficiency virus infection or use of an immunosuppressive medication except immunoglobulin A deficiency
    6. Subjects who received (within 12 months before Screening) or who are currently on a waiting list for a bone marrow, stem cell, or solid organ transplant, or who received radiation or chemotherapy (within 12 months before screening)
    7. Subjects who have had major surgery in the 6 weeks before randomization
    8. Subject receiving chronic oxygen therapy at home before admission
    9. Subjects who are being breastfed by a mother taking any of the excluded medications
    10. Subjects whose mother received an investigational RSV vaccination while pregnant with the subject
    11. Receipt of systemic antiviral, , antifungal, or antimycobacterial therapy within 7 days of Screening
    12. Subjects who received systemic medications (either chronically [more than 14 days] or within 21 days before randomization) that are known to modulate the host’s immune response or increase viral shedding, such as immunomodulatory therapies. Systemic corticosteroids are not prohibited in Part 1
    13. Subjects who are receiving an investigational or approved medication that is intended to prevent or treat RSV infection (eg, ribavirin or palivizumab or other RSV specific monoclonal antibody) within 30 days or 5 half-lives (whichever is longer) before the first dose of study drug, and/or is currently enrolled in a clinical trial of such a medication.RSV-specific monoclonal antibodies are not prohibited in Part 1.
    14. Use of or intention to use any medication or supplement known to be a moderate or strong inducer or inhibitor of the cytochrome P450 3A4 enzyme within 14 days before the first dose of study drug
    15. Subjects who are enrolled in another investigational drug or vaccine study
    16. Known allergy/hypersensitivity or intolerance to EDP-938 placebo or their excipients
    E.5 End points
    E.5.1Primary end point(s)
    Part 1
    1) PK parameters of EDP-938 including area under the curve (AUC) and predose concentrations
    2) Safety and tolerability of EDP-938 compared to placebo as assessed by, but not limited to, AEs, vital signs, and clinical laboratory results

    Part 2
    1) Daily change in RSV shedding in nasal swab samples determined using quantitative qPCR from before the first dose of study drug (Baseline) through treatment phase
    E.5.1.1Timepoint(s) of evaluation of this end point
    Part 1
    1) From Day 1 up to 10 hours post Day 5 dose
    2) From baseline up to Day 28

    Part 2
    1) From baseline up to Day 14
    E.5.2Secondary end point(s)
    Part 1
    1) AUC for RSV RNA viral load measured in nasal swab samples by quantitative reverse transcription polymerase chain reaction (RT-qPCR)
    2) Daily change in RSV shedding in nasal swab samples determined using RT-qPCR from before the first dose of study drug (Baseline) through the treatment phase
    3) Proportion of subjects with RSV RNA viral load below the limit of detection (LOD) in subjects receiving EDP-938 compared to placebo
    4) Time to RSV RNA viral load being undetectable

    Part 2
    1) Safety and tolerability of EDP-938 compared to placebo as assessed by, but not limited to, AEs, vital signs, and clinical laboratory results
    2) AUC for RSV RNA viral load measured in nasal swab samples by RT-qPCR
    3) Proportion of subjects with RSV RNA viral load below the LOD in subjects receiving EDP-938 compared to placebo
    4) Time to RSV RNA viral load being undetectable
    5) PK parameters of EDP-938 including AUC and predose concentrations
    6) Time to discharge for hospitalized subjects;
    7) Time to use of oxygen for hospitalized subjects who are not receiving oxygen at the time they receive the first dose of study drug;
    8) Proportion of hospitalized subjects requiring oxygen supplementation or have an increased oxygen requirement
    9) Time to mechanical ventilation for hospitalized subjects;
    10) Proportion of hospitalized subjects requiring mechanical ventilation;
    11) Deaths among hospitalized subjects;
    12) Time to hospitalization for initial outpatients who are subsequently hospitalized;
    13) Proportion of outpatients who are subsequently hospitalized or died;
    14) Time to resolution of symptoms for outpatients who are not hospitalized.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Part 1
    1) From baseline up to Day 14
    2) From baseline up to Day 14
    3) From baseline up to Day 14
    4) From baseline up to Day 14

    Part 2
    1) From baseline up to Day 28
    2) From baseline up to Day 14
    3) From baseline up to Day 14
    4) From baseline up to Day 14
    5) From Day 1 up to 10 hours post Day 5 dose
    6) to 14) From baseline up to Day 28
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 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 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 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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
    Argentina
    Australia
    Brazil
    Israel
    Korea, Republic of
    Mexico
    New Zealand
    South Africa
    Taiwan
    United States
    Germany
    Poland
    Romania
    Spain
    United Kingdom
    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
    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 months5
    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 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 Yes
    F.1.1Number of subjects for this age range: 90
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 84
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 6
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    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 Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    infants and toddlers (≥28 days to ≤36 months)
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 25
    F.4.2.2In the whole clinical trial 90
    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
    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 Decision2021-05-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-02-23
    P. End of Trial
    P.End of Trial StatusOngoing
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