Respiratory syncytial virus (RSV) MedDRA version: 21.1 Level: PT Classification code 10061603 Term: Respiratory syncytial virus infection System Organ Class: 10021881 - Infections and infestations
Conditions
Sponsors
Enanta Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. An ICF signed and dated by the subject 2. Male or female individuals aged between 16 and 75 years, inclusive 3. Received an autologous HCT (within 6 months of signing ICF) or an allogeneic HCT (any time) using any conditioning regimen 4. Absolute lymphocyte count (ALC) 35 mIU/mL will also be considered to be postmenopausal.) 12. A male subject who has not had a vasectomy and is sexually active with a woman of childbearing potential must agree to use effective contraception from the date of Screening to 90 days after his last dose of study drug. Effective contraception is defined as a condom and at least one of the following for a female partner: a. Intrauterine device b. Oral, injectable, implantable, transdermal, or intravaginal contraceptive (Note: hormonal contraception must be associated with the inhibition of ovulation). 13. Male subjects must agr
Exclusion criteria
Exclusion criteria: 1. Admitted to the hospital primarily for a lower respiratory tract disease of any cause as determined by the Investigator. 2. Known to be concurrently infected with other respiratory viruses (eg, severe acute respiratory syndrome coronavirus 2 [SARS-CoV-2] or other coronavirus, influenza, parainfluenza, human rhinovirus, adenovirus, human metapneumovirus) within 7 days before signing the ICF, as determined by local testing. 3. Clinically significant viremia, bacteremia, or fungemia, or bacterial or fungal pneumonia within 2 weeks before signing the ICF that has not been adequately treated, as determined by the Investigator. 4. Pregnant or nursing female subjects. 5. History of drug and/or alcohol abuse that, in the opinion of the Investigator, may prevent adherence to protocol activities. 6. Known positive human immunodeficiency virus (HIV). 7. Heart disease: any congenital heart disease, congenital long QT syndrome, or any clinical manifestation resulting in QT interval prolongation. Chronic heart failure or ischemic heart disease or cardiac disease occurring as a consequence of antineoplastic treatment and for which treatment medications have not added or increased in the last 3 months are not exclusionary. 8. Known malignant tumor that may interfere with the aims of the study or a subject completing the study. 9. Prior or planned ileal resection or bariatric surgery. Subjects who have undergone gastric surgeries that do not affect drug absorption (eg, gastric band or gastric sleeve procedures) will be allowed to participate if they are stable for at least 1 year before signing the ICF. Gastrectomy will be allowed if stable for at least 3 years before signing the ICF. 10. Estimated glomerular filtration rate by Modification of Diet in Renal Disease (MDRD) 5 × ULN as measured in the 3 days before signing the ICF or at Screening. 12. Twelve-lead ECG demonstrating a QT interval corrected for heart rate according to Fridericia (QTcF) that is > 470 milliseconds or other clinically relevant abnormalities as judged by the Investigator at Screening. 13. Use of or intention to use any medication or supplement known to be a moderate or strong inducer or inhibitor of the CYP3A4 enzyme (Section 5.8) within 14 days before signing the ICF, with the exception of prophylactic azole antifungal therapies (e.g., fluconazole, itraconazole, ketoconazole, isavuconazole, posaconazole, and voriconazole), which are permitted with EDP-938 dose adjustment (Section 4.2.2) 14. Use of nonmarketed (according to region) or investigational agents, vaccines, biological products within 30 days or five half-lives before signing the ICF, whichever is longer. 15. Use of any investigational monoclonal anti-RSV antibodies within 4 months or five half-lives of signing the ICF, whichever is longer, or use of any investigational RSV vaccines after HCT. 16. Known hypersensitivity or allergy to EDP-938 or placebo or their excipients. 17. History of or currently experiencing a medical condition or any other finding (including laboratory test results) that, in the opinion of the Investigator, might confound the results of the study, pose an additional risk in administering study drug to the subject, could prevent, limit, or confound the protocol-specified assessments, or deems the subject unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of EDP-938 on the development of lower respiratory tract complication (LRTC) in HCT subjects with an acute RSV URTI;Secondary Objective: • To evaluate the effect of EDP-938 on RSV viral load as measured by quantitative reverse transcription polymerase chain reaction (RT-qPCR) of nasopharyngeal swab samples • To evaluate the effect of EDP-938 on progression to respiratory failure or all-cause mortality • To evaluate the progression of RSV infection using the InFLUenza Patient-Reported Outcome questionnaire • To evaluate the pharmacokinetics (PK) of EDP-938 and its metabolites • To evaluate the safety and tolerability of EDP-938 • To evaluate the effect of EDP-938 on infectious RSV viral load in nasopharyngeal swab samples as determined by a quantitative cell-based infectivity assay • To evaluate the relationship between the PK of EDP-938 and antiviral and clinical efficacy • To evaluate the incidence of major clinical events • To evaluate the length of hospital stay and time in the (ICU) • To evaluate the use of certain therapeutics • To evaluate the emergence of viral resistance with EDP-938 treatment ;Primary end point(s): • Incidence of LRTC through Day 28 defined as at least one of the following as determined by the Endpoint Adjudication Committee o Lower respiratory tract infection (LRTI) by RSV o LRTI as secondary bacterial pneumonia o LRTI by unusual pathogens o LRTC of unknown etiology;Timepoint(s) of evaluation of this end point: day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Change in RSV RNA viral load from Baseline through Day 49 in nasopharyngeal swab samples by RT-qPCR • Incidence of subjects who develop respiratory failure of any cause requiring mechanical ventilation (invasive or noninvasive) or all-cause mortality through Day 49 • Incidence of subjects with RSV RNA viral load below the limit of detection in subjects receiving EDP-938 through Day 49 • Time to RSV RNA viral load below the limit of detection • FLU-PRO questionnaire scores through Day 49 • Plasma PK concentrations of EDP-938 and its metabolites (EP-024636, EP-024594, EP-024595 and EP-024766) • Safety endpoints include, but are not limited to, adverse events (AEs), serious adverse events (SAEs), vital sign measurements, pulse oximetry measurements, and clinical laboratory test results (including chemistry, hematology, and urinalysis);Timepoint(s) of evaluation of this end point: day 49 | — |
Countries
Argentina, Australia, Belgium, Brazil, Canada, Colombia, France, Germany, Greece, Hong Kong, Israel, Italy, Korea, Republic of, Mexico, Netherlands, Poland, South Africa, Spain, Sweden, Taiwan, Turkey, United Kingdom, United States
Contacts
Public ContactRegulatory Affairs
Enanta Pharmaceuticals, Inc.
Outcome results
None listed