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

• ClinicalTrials.gov Identifier: NCT04633187
• Recruitment Status: Recruiting
• First Posted: November 18, 2020
• Last Update Posted: October 14, 2022
• Sponsor: Enanta Pharmaceuticals, Inc
• Information provided by (Responsible Party): Enanta Pharmaceuticals, Inc

Tracking Information

• First Submitted Date: November 11, 2020
• First Posted Date: November 18, 2020
• Last Update Posted Date: October 14, 2022
• Actual Study Start Date: July 7, 2021
• Estimated Primary Completion Date: April 2024 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: November 11, 2020): Proportion of subjects who develop Lower Respiratory Tract (LRTC) complication [ Time Frame: Day 1 through Day 28 ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: November 11, 2020)

• Change from baseline in RSV RNA viral load [ Time Frame: Day 1 through Day 49 ]
• 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 ]
• Safety as measured by frequency of adverse events (AEs) [ Time Frame: Day 1 through Day 49 ]
• Plasma PK Concentrations of EDP-938 [ Time Frame: Day 0 through Day 21 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effects of EDP-938 in Hematopoietic Cell Transplant Recipients Who Are Infected With Acute Respiratory Syncytial Virus (RSV) of the Upper Respiratory Tract
• 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Respiratory Syncytial Virus Infections

Intervention

• Drug: EDP-938

  EDP-938 800mg

  Dose adjustments will be made for subjects taking azole antifungals.

• Drug: Placebo
  Subjects will take EDP-938 matching placebo tablets once a day orally for 21 days

Study Arms

• Experimental: EDP-938
  Intervention: Drug: EDP-938
• Placebo Comparator: Placebo
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: November 11, 2020): 200
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: April 2024
• Estimated Primary Completion Date: April 2024 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 16 Years to 75 Years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

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

• Listed Location Countries: Argentina, Australia, Belgium, Brazil, Canada, China, Colombia, France, Germany, Greece, Israel, Italy, Korea, Republic of, Mexico, Poland, South Africa, Spain, Taiwan, Turkey, United Kingdom, United States

Administrative Information

• NCT Number: NCT04633187
• Other Study ID Numbers: EDP 938-103
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Enanta Pharmaceuticals, Inc
• Original Responsible Party: Same as current
• Current Study Sponsor: Enanta Pharmaceuticals, Inc
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Enanta Pharmaceuticals, Inc; Enanta Pharmaceuticals, Inc

• PRS Account: Enanta Pharmaceuticals, Inc
• Verification Date: May 2022