Clinical Trials Directory

Trials / Terminated

TerminatedNCT04633187

Effects of EDP-938 in Hematopoietic Cell Transplant Recipients Infected With Respiratory Syncytial Virus of the Upper Respiratory Tract

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

Status
Terminated
Phase
Phase 2
Study type
Interventional
Enrollment
9 (actual)
Sponsor
Enanta Pharmaceuticals, Inc · Industry
Sex
All
Age
16 Years – 75 Years
Healthy volunteers
Not accepted

Summary

This was 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.

Conditions

Interventions

TypeNameDescription
DRUGEDP-938EDP-938 800mg Dose adjustments were made for subjects taking azole antifungals.
DRUGPlaceboSubjects took EDP-938 matching placebo tablets once a day orally for 21 days

Timeline

Start date
2021-07-07
Primary completion
2023-05-31
Completion
2023-05-31
First posted
2020-11-18
Last updated
2024-08-22
Results posted
2024-08-22

Locations

64 sites across 19 countries: United States, Argentina, Belgium, Brazil, Canada, China, Colombia, France, Greece, Israel, Italy, Mexico, Poland, South Africa, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom

Regulatory

Source: ClinicalTrials.gov record NCT04633187. Inclusion in this directory is not an endorsement.