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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04633187
Recruitment Status : Recruiting
First Posted : November 18, 2020
Last Update Posted : October 14, 2022
Sponsor:
Information provided by (Responsible Party):
Enanta Pharmaceuticals, Inc

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Respiratory Syncytial Virus Infections Drug: EDP-938 Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Effects of EDP-938 in Hematopoietic Cell Transplant Recipients With Acute Respiratory Syncytial Virus Infection of the Upper Respiratory Tract
Actual Study Start Date : July 7, 2021
Estimated Primary Completion Date : April 2024
Estimated Study Completion Date : April 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: EDP-938 Drug: EDP-938

EDP-938 800mg

Dose adjustments will be made for subjects taking azole antifungals.
Placebo Comparator: Placebo Drug: Placebo
Subjects will take EDP-938 matching placebo tablets once a day orally for 21 days


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of subjects who develop Lower Respiratory Tract (LRTC) complication [ Time Frame: Day 1 through Day 28 ]

Secondary Outcome Measures :
  1. Change from baseline in RSV RNA viral load [ Time Frame: Day 1 through Day 49 ]
  2. Proportion of Subjects Progressing to Respiratory Failure (of any Cause) Requiring Mechanical Ventilation (Invasive or Noninvasive) or all-cause mortality [ Time Frame: Day 1 through Day 49 ]
  3. Safety as measured by frequency of adverse events (AEs) [ Time Frame: Day 1 through Day 49 ]
  4. Plasma PK Concentrations of EDP-938 [ Time Frame: Day 0 through Day 21 ]

Eligibility Criteria
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Ages Eligible for Study:   16 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Received an autologous HCT (within 6 months of signing ICF) or an allogeneic HCT (any time) using any conditioning regimen
  • Absolute lymphocyte count (ALC) <500 cells/ µL in allogeneic HCT recipients. Absolute lymphocyte count (ALC) <300 cells/ µL in autologous HCT recipients.
  • Laboratory confirmed RSV diagnosis from a respiratory sample obtained within 3 days before 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 imaging (chest x-ray and/or computed tomography) performed in the 2 days before signing the ICF or at the Screening visit if there is no chest X-ray and/or computed tomography available in the 2 days before signing the ICF.
  • Oxygen saturation >95% 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04633187


Contacts
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Contact: Enanta Pharmaceuticals, Inc (617) 607-0800 gdelarosa@enanta.com

Locations
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Sponsors and Collaborators
Enanta Pharmaceuticals, Inc
Investigators
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Study Director: Enanta Pharmaceuticals, Inc Enanta Pharmaceuticals, Inc
More Information
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Responsible Party: Enanta Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT04633187    
Other Study ID Numbers: EDP 938-103
First Posted: November 18, 2020    Key Record Dates
Last Update Posted: October 14, 2022
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infections
Virus Diseases
Respiratory Syncytial Virus Infections
Pneumovirus Infections
 Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections