Respiratory Syncytial Virus InfectionsPhase 2RSVTxNCT04633187
Effects of EDP-938 in Hematopoietic Cell Transplant Recipients Infected With Respiratory Syncytial Virus of the Upper Respiratory Tract
A Phase 2 study testing EDP-938 in people with Respiratory Syncytial Virus Infections, run by Enanta Pharmaceuticals, Inc at 64 sites in 19 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 75 years
- Conditions the study is for
- Respiratory Syncytial Virus Infections
- What is being tested?
- EDP-938
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 64 sitesin 19 countries
- Study dates
- 7 Jul 2021to 31 May 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
64 sites in 19 countries.
64 sites in 19 countries
Spain13 sites
Hospital Clinic de Barcelona
Barcelona, 08036
Hospital de San Pedro de Alcantara
Cáceres, Caceres, 10003
Hospital Universitario Virgen de La Arrixaca
El Palmar, Murcia, 30120
Hospital Universitario Virgen de Las Nieves
Granada, 18014
ICO l'Hospitalet - Hospital Duran i Reynals
L'Hospitalet de Llobregat, Barcelona, 08908
Hospital Universitario Ramon y Cajal
Madrid, 28034
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Universitario La Paz - PPDS
Madrid, 28046
Hospital Regional Universitario de Malaga - Hospital General
Málaga, 29010
Hospital General Universitario Morales Meseguer
Murcia, 30008
Hospital Universitario Son Espases
Palma de Mallorca, Balearic Islands, 07010
Hospital Universitario Virgen del Rocio - PPDS
Seville, 41013
Hospital Clinico Universitario de Valencia
Valencia, 46026
Brazil6 sites
Fundação PIO XII
Barretos, São Paulo, 14784
Chronos Pesquisa Clínica
Brasília, Federal District, 72145-450
Hospital de Clinicas de Porto Alegre (HCPA) - PPDS
Porto Alegre, Rio Grande do Sul, 90035
Hospital Universitário de Santa Maria
Santa Maria, Rio Grande do Sul, 97105-900
Hospital Alemão Oswaldo Cruz
São Paulo, São Paulo, 01323-903
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, São Paulo, 05403000
Italy6 sites
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona-Umberto I G.M. Lancisi G. Salesi
Ancona, The Marches, 60020
ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia - INCIPIT - PIN
Brescia, Lombardy, 25123
Azienda Ospedaliera Universitaria Careggi
Florence, 50134
A.O.U. Maggiore della Carità
Novara, Piedmont, 28100
Fondazione Policlinico Universitario A Gemelli
Roma, 00168
Azienda ULSS 8 "Berica" - Ospedale San Bortolo
Vicenza, Veneto, 36100
France5 sites
Hôtel Dieu -Angers
Angers, Maine-et-Loire, 49933
Hopital Cote de Nacre
Caen, 14000
Hôpital Claude Huriez
Lille, Nord, 59037
CHU de Nice
Nice, Alpes-Maritimes, 06202
Hôpital Saint Antoine
Paris, 75012
South Korea5 sites
Chungnam National University Hospital
Daejeon, 301-721
Seoul National University Hospital
Seoul, 03080
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, 06591
Samsung Medical Center
Seoul
Gachon University Gil Medical Center
Ulsan, 682714
Argentina4 sites
Fundación Favaloro
Buenos Aires, Ciudad Autónoma de BuenosAires, C1093AAS
Hospital Britanico de Buenos Aires
Buenos Aires, C1280AEB
Sanatorio Allende S.A.
Córdoba, Córdoba Province, X5000JHQ
Instituto Fides
La Plata, Ciudad Autónoma de BuenosAires, 483 5051
Israel4 sites
Rambam Medical Center
Haifa, 31096
Hadassah Medical Center
Jerusalem, 91120
Sheba Medical Center
Ramat Gan, 52621
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239
Belgium3 sites
Institute Jules Bordet
Anderlecht, Brussels Capital, 1070
UZ Antwerpen
Edegem, Antwerpen, 2650
Hôpital de Jolimont
La Louvière, 7100
South Africa3 sites
WITS Clinical Research Site
Johannesburg
Albert Alberts Stem Cell Transplant Centre
Pretoria, Gauteng, 0044
FCRN Clinical Trial Centre (Pty) Ldt
Vereeniging, Gauteng, 1935
Turkey (Türkiye)3 sites
Ege Universitesi Tip Fakultesi Hastanesi
Bornova, İzmir
Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
Samsun
Namik Kemal University
Tekirdağ, Tekirdağ
Greece2 sites
Attikon University General Hospital
Athens
Evangelismos General Hospital of Athens
Athens
Poland2 sites
Uniwersyteckie Centrum Kliniczne
Gdansk
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy Oddzial w Gliwi
Gliwice, Silesian Voivodeship
Taiwan2 sites
Changhua Christian Medical Foundation Changhua Christian Hospital
Changhua, 50006
Taipei Veterans General Hospital
Taipei
United States1 site
Augusta University Medical Center
Augusta, Georgia, 30912
About this study
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
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
- Respiratory Syncytial Virus Infections
- Being tested
- EDP-938, Placebo
- Medical subject headings
- Respiratory Syncytial Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EDP-938Drug
EDP-938 800mg
Dose adjustments were made for subjects taking azole antifungals.
PlaceboDrug
Subjects took EDP-938 matching placebo tablets once a day orally for 21 days
| Study group | Role | What they receive |
|---|---|---|
| EDP-938 | Experimental | Not described Receives: Drug: EDP-938 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects Who Develop Lower Respiratory Tract (LRTC) Complication
Measured: Day 1 through Day 28
Secondary outcomes (4)
Change From Baseline in RSV RNA Viral Load
Measured: 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
Measured: Day 1 through Day 49
Safety as Measured the Number of Participants With at Least One Treatment-emergent Adverse Event
Measured: Day 1 through Day 49
Plasma PK Concentrations of EDP-938 800mg
Measured: Day 1 Predose and Postdose, Day 4 Predose, Day 7 Predose and Postdose, Day 11 Predose, Day 16 Predose, Day 21 Predose and Postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2020
- Study start7 Jul 2021
- Primary completion31 May 2023
- Study completion31 May 2023
Why it stopped: Study was terminated due to a strategic business decision and not due to safety concerns.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Respiratory Syncytial Virus InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Enanta Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Enanta Pharmaceuticals, Inc, Study director, Enanta Pharmaceuticals, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04633187
- Sponsor's protocol ID
- EDP 938-103
- Acronym
- RSVTx
- Status last verified
- Jul 2024
- First submitted
- 11 Nov 2020
- Last updated
- 22 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04633187
- Acronym / sponsor ID
- RSVTx / EDP 938-103
- Conditions
- Respiratory Syncytial Virus Infections
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was terminated due to a strategic business decision and not due to safety concerns.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Enanta Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- 7 Jul 2021 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 18 Nov 2020 (actual)
- Results
- Posted 22 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EDP-938 | Experimental | Drug: EDP-938 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EDP-938EDP-938 800mg Dose adjustments were made for subjects taking azole antifungals. | Drug | EDP-938 |
| PlaceboSubjects took EDP-938 matching placebo tablets once a day orally for 21 days | Drug | Placebo |
Primary outcome
Percentage of Subjects Who Develop Lower Respiratory Tract (LRTC) Complication
Time frame: Day 1 through Day 28
4 secondary outcomes
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 the Number of Participants With at Least One Treatment-emergent Adverse Event
Time frame: Day 1 through Day 49
Plasma PK Concentrations of EDP-938 800mg
Time frame: Day 1 Predose and Postdose, Day 4 Predose, Day 7 Predose and Postdose, Day 11 Predose, Day 16 Predose, Day 21 Predose and Postdose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Enanta Pharmaceuticals, Inc study director
Enanta Pharmaceuticals, Inc
64 sites in 19 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EDP-938 in people with Respiratory Syncytial Virus Infections, run by Enanta Pharmaceuticals, Inc at 64 sites in 19 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 64 sites in Spain, Brazil, Italy, France, South Korea and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Subjects Who Develop Lower Respiratory Tract (LRTC) Complication (time frame: Day 1 through Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2024.