Effects of EDP-938 in Adult Hematopoietic Cell Transplant Recipients Who Are Infected With Acute Respiratory Syncytial Virus (RSV) of the Upper Respiratory Tract

  • STATUS
    Recruiting
  • End date
    Dec 15, 2022
  • participants needed
    200
  • sponsor
    Enanta Pharmaceuticals
Updated on 25 August 2021

Summary

This is a Phase 2b, randomized, double-blind, placebo-controlled, multicenter study evaluating the efficacy and safety of EDP-938 in HCT recipients with acute RSV infection and symptoms of URTI.

Details
Condition rsv infection, Respiratory syncytial virus infection
Treatment Placebo, EDP-938
Clinical Study IdentifierNCT04633187
SponsorEnanta Pharmaceuticals
Last Modified on25 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Received an autologous or allogeneic HCT using any conditioning regimen
Absolute lymphocyte count (ALC) <500 cells/ L
Laboratory confirmed RSV diagnosis from a respiratory sample obtained not more than 3 days prior signing the ICF
New onset of at least one of the following respiratory symptoms within 3 days before signing the ICF: nasopharyngeal discharge, nasopharyngeal congestion, sneezing, sinus congestion, sore throat, hoarseness, earache, cough, shortness of breath, respiratory wheeze, or worsening of one of these symptoms if present chronically (associated with a previously existing diagnosis [eg, chronic rhinorrhea, chronic lung disease]) in the 3 days before signing the ICF or at Screening
No evidence of new abnormalities consistent with LRTI on a chest X-ray performed in the 2 days before signing the ICF or at the Screening visit if there is no chest X-ray available in the 2 days before signing the ICF
Oxygen saturation >92% on room air
A woman of childbearing potential who is sexually active with a male must agree to use two effective methods of contraception from the date of Screening until 30 days after her last dose of study drug
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

Exclusion Criteria

Admitted to the hospital primarily for a lower respiratory tract disease of any cause as determined by the Investigator
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
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
Known positive human immunodeficiency virus (HIV)
Any clinical manifestation resulting in QT prolongation
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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