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EDP-938 for Children with RSV (RSVPEDs Trial)
Phase 2
Recruiting
Research Sponsored by Enanta Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects diagnosed with RSV infection
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 29 days
Awards & highlights
RSVPEDs Trial Summary
This trial will study the effects of EDP-938 in children with RSV infection. The safety, pharmacokinetics, and efficacy of EDP-938 will be evaluated.
Who is the study for?
This trial is for children with RSV infection. It includes kids aged 6 months to less than 3 years, and infants from about a month old to under 6 months who were born after at least 29 weeks of pregnancy. Caregivers must understand the study's needs and ensure the child can complete it. Children on certain life support, with recent transplants or cancer treatments, chronic oxygen therapy, immune deficiencies, or recent RSV medications are excluded.Check my eligibility
What is being tested?
The study tests EDP-938 against a placebo in two parts to check its safety and effectiveness in treating RSV in children. The first part will focus on how well the drug works and if it's safe; the second part will look into how much of the drug gets into the bloodstream and how long it stays there.See study design
What are the potential side effects?
While specific side effects for EDP-938 aren't listed here, common side effects for antiviral drugs like this may include nausea, vomiting, diarrhea, headache, dizziness, fatigue or allergic reactions. Each child's experience could vary.
RSVPEDs Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with an RSV infection.
RSVPEDs Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 29 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 29 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
AUC of EDP-938 (Part 1)
Daily change from baseline in RSV shedding (Part 2)
Predose concentration of EDP-938 (Part 1)
+1 moreSecondary outcome measures
AUC for RSV RNA viral load (Part 1 and Part 2)
AUC of EDP-938 (Part 2)
Daily change in RSV shedding (Part 1)
+7 moreSide effects data
From 2022 Phase 2 trial • 82 Patients • NCT041961015%
Diarrhoea
5%
Urinary tract infection
3%
Urine ketone body present
3%
Blood chloride decreased
3%
Anaemia
3%
Alanine aminotransferase increased
3%
Dyspepsia
3%
Protein total decreased
3%
Blood creatine phosphokinase increased
3%
Blood cholesterol increased
3%
Hepatic function abnormal
3%
Leukocytosis
3%
Blood sodium decreased
3%
Headache
3%
Haemoptysis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
EDP-938
RSVPEDs Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: EDP-938Experimental Treatment1 Intervention
EDP-938, oral suspension, once daily for 5 days
Group II: PlaceboPlacebo Group1 Intervention
Matching placebo, orally, once daily for 5 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
EDP-938
2021
Completed Phase 2
~420
Find a Location
Who is running the clinical trial?
Enanta PharmaceuticalsLead Sponsor
33 Previous Clinical Trials
2,258 Total Patients Enrolled
Enanta Pharmaceuticals, IncLead Sponsor
39 Previous Clinical Trials
2,894 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not need life support treatments and am expected to survive my current illness.I am a child aged between 28 days and 36 months, and if under 6 months, I was born after 29 weeks of gestation.I have not had, nor am I waiting for, any transplant or received chemotherapy or radiation in the last year.I use oxygen at home regularly before being admitted.I haven't taken any medication to prevent or treat RSV infection recently.I have been diagnosed with an RSV infection.I have an immune deficiency not including IgA deficiency.I started showing symptoms of a respiratory illness less than a week ago.
Research Study Groups:
This trial has the following groups:- Group 1: EDP-938
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there currently enrollment for this investigation?
"Clinicaltrials.gov has verified that this trial is still accepting new participants, with the first posting of its recruitment efforts being on April 26th 2022 and a subsequent update occurring October 9th 20202."
Answered by AI
Could you summarize the potential risks associated with EDP-938?
"With only limited safety data available, EDP-938 received a score of 2 on our team's risk scale. This Phase 2 trial has yet to demonstrate any efficacy."
Answered by AI
Is it feasible to enroll in this research project?
"Those hoping to participate in the study must have been diagnosed with Respiratory Syncytial Virus and range between 28 days old up until no older than 36 months of age. The total number of participants sought is 90 individuals."
Answered by AI
What is the geographic breadth of this research endeavor?
"The research protocol is currently being implemented at 13 different sites, including Hollywood, Jacksonville and Chicago. To reduce transportation needs for the patients involved in this study, we recommend selecting a clinic that's close to your residence."
Answered by AI
Do individuals who have exceeded forty years of age qualify for this investigation?
"The enrollment qualifications set forth in this research trial specify that the youngest participants must be at least 28 days old and no more than 36 months of age."
Answered by AI
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