RhinovirusPhase 2NCT03024177
A Study of Vapendavir Treatment of Hematopoietic Stem Cell Transplant Subjects With Symptomatic Rhinovirus Infection
A Phase 2 study testing Vapendavir in people with Rhinovirus and Upper Respiratory Tract Infection, run by Vaxart.
Trial summary
This is a randomized, double-blind, placebo-controlled study of vapendavir treatment of laboratory-confirmed and symptomatic HRV infection of the upper respiratory tract in allogeneic and autologous stem cell transplant subjects. Read more about this study
- Who is it for?
- Ages 16 to 75 years
- Conditions the study is for
- Rhinovirus, Upper Respiratory Tract Infection
- What is being tested?
- Vapendavir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento Apr 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Allogeneic or autologous HSC transplant within last 6 months using any conditioning regimen, or HSC transplant subjects with current chronic graft vs host disease requiring systemic treatment at any time point post-transplant;
- Documented HRV in the upper respiratory tract (e.g., nasal swab, nasopharyngeal swab, nasal wash) as determined by local testing;
- Subject presents to clinic reporting symptoms of a cold with the presence of at least 2 symptoms associated with HRV infection and with an onset such that they can be randomized and dosed preferably within 72 hours but up to a 5 day window (120 hours) interval from symptom onset to study treatment initiation;
- Capable of giving written informed consent that includes compliance with the requirements and restrictions listed in the consent form. Informed consent and subject assent for subjects below the legal age of consent will be documented by means of a written, signed, and dated ICF and assent document. For subjects below the legal age of consent, the parent/legal guardian will provide informed consent and subjects below the legal age of consent will provide assent to participate in the study, in compliance with local regulations;
- Subject is able to understand and comply with the protocol requirements;
- Ability to maintain adequate oral intake of medication;
- Female subjects who are not postmenopausal for at least 2 years or surgically sterile with complete hysterectomy or bilateral oophorectomy and male subjects, who are not surgically sterile via vasectomy, must agree to use a double barrier method of birth control, such as, a condom plus spermicidal agent (foam/gel/film/cream/suppository) from the time of randomization until 30 days after completion of study drug dosing. Male subjects cannot donate sperm during the study starting at day 1 and for 90 days after completion of study drug dosing;
- Female subjects must not be breastfeeding or pregnant.
Who cannot join
- Positive test result within 5 days prior to Study Day 1 inclusive for any of the following viral respiratory pathogen that are not HRV: respiratory syncytial virus, influenza, parainfluenza, adenovirus, or human metapneumovirus;
- Clinically significant bacterial, fungal, or viral lower respiratory tract infection within 2 weeks prior to Study Day 1 (subject cannot have lower respiratory tract infection at Study Day 1) inclusive that has not been adequately treated, as determined by the investigator;
- Clinically significant systemic bacteremia or fungemia within 7 days prior to Study Day 1 that has not been adequately treated, as determined by the investigator and the Medical Monitor;
- Subjects receiving high dose systemic steroids defined as >2mg/kg per day or prednisone or prednisone equivalent currently or within the 7 days prior to Study Day 1;
- Subjects with diagnosis of a lower respiratory infection at Study Day 1, subjects with O2 saturation of less than 92% in the absence of supplemental oxygen, or those requiring invasive mechanical ventilation or non-invasive mechanical ventilation with BIPAP or CPAP at the time of randomization, and/or a history or current evidence of chronic obstructive airways disease, emphysema, cystic fibrosis or current, uncontrolled or severe asthma;
- Moderate to severe hepatic veno-occlusive disease (VOD), now known as moderate to severe sinusoidal obstructive syndrome (SOS), defined as meeting Baltimore Criteria for moderate or severe VOD disease;
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- At the time of randomization, currently in hospice, or at overt risk of death, in the judgment of the investigator. If relapsed with hematologic malignancy, subject may be enrolled if status not futile and subject expected at the time of randomization to survive to complete the study;
- Subjects with absolute lymphocyte count of >2000 cells/mm3 within 5 days of randomization (Study Day 1);
- Subjects with other known clinical significant laboratory abnormalities from local lab testing performed within 30 days prior to Study Day 1 will be considered for inclusion, if in the opinion of the investigator or Medical Monitor the abnormalities will not significantly jeopardize the safety of the subject or are related to the underlying study disease and/or transplant and the abnormalities will not impair the validity of the study;
- Known history of estimated creatinine clearance < 50 mL/min (as calculated via the Cockcroft-Gault method);
- Known history of HIV/AIDS. Known history of active HBV or HCV infection that has not resolved with treatment;
- Current abuse of alcohol or any use of illicit drugs;
- Received an investigational drug or investigational vaccine within 14 calendar days or 5 half-lives (whichever is longer) which does have US market approval for a related indication or different dosing regimen, or use of an investigational medical device within 14 calendar days prior to Study Day 1, or has received vapendavir at any previous time;
- Subjects unable to tolerate bilateral nasopharyngeal sampling required for this study, as determined by the investigator.
About this study
Official title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study of Vapendavir Treatment of Hematopoietic Stem Cell Transplant Subjects With Symptomatic Rhinovirus Infection
This is a randomized, double-blind, placebo-controlled study of vapendavir treatment of laboratory-confirmed and symptomatic HRV infection of the upper respiratory tract in allogeneic and autologous stem cell transplant subjects. The aim of this study is to evaluate the effect of vapendavir on laboratory-confirmed HRV upper-respiratory tract infection in HSCT patients, as measured by viral load changes, worsening of upper respiratory tract infection (URTI) to lower respiratory tract infection (LRTI), duration of clinical symptoms, the occurrence of supplemental oxygen use, duration of viral shedding, hospital admission and duration of hospitalization, incidence of secondary bacterial infection, and mortality rates. Additionally, the safety and tolerability of vapendavir, and the vapendavir plasma levels achieved in the HSCT population, and the profile of viral resistance development will also be assessed.
- Conditions
- Rhinovirus, Upper Respiratory Tract Infection
- Being tested
- Vapendavir, Placebo Oral Tablet
- Keywords
- Human rhinovirus, HRV, Hematopoietic Stem Cell Transplant, HSCT, Antiviral, vapendavir, Allogeneic, Autologous
- Medical subject headings
- Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VapendavirDrug
Also called BTA798
Vapendavir Tablets, 264 mg
Placebo Oral TabletDrug
Vapendavir 264 mg matching tablets
| Study group | Role | What they receive |
|---|---|---|
| Vapendavir 528 mg | Experimental | Not described Receives: Drug: Vapendavir |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy: Time-weighted average change from baseline to end of treatment visit in HRV viral load (HRV-RNA log10 copies/mL)
Measured: Study Day 1 to end of treatment (Study Day 14)
Safety: Proportion of treatment-emergent adverse events
Measured: Study Day 1 - 90
Safety: Proportion of treatment-related serious adverse events
Measured: Study Day 1 - 90
Safety: Incidence of treatment-emergent Grade 3 or greater clinical laboratory abnormalities
Measured: Study Day 1 - 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2017 (estimated)
- Primary completionApr 2017
Why it stopped: Study is withdrawn due to company decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RhinovirusStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vaxart
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anna Novotney-Barry, Study director, Aviragen Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03024177
- Sponsor's protocol ID
- BTA798-204
- Status last verified
- May 2018
- First submitted
- 12 Jan 2017
- Last updated
- 7 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study of Vapendavir Treatment of Hematopoietic Stem Cell Transplant Subjects With Symptomatic Rhinovirus Infection
- ClinicalTrials.gov ID
- NCT03024177
- Acronym / sponsor ID
- BTA798-204
- Conditions
- Rhinovirus, Upper Respiratory Tract Infection
- Keywords
- Human rhinovirus, HRV, Hematopoietic Stem Cell Transplant, HSCT, Antiviral, vapendavir, Allogeneic, Autologous
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study is withdrawn due to company decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- VaxartIndustry (pharma, biotech, devices)
- Primary completion
- Apr 2017 (actual)
- First posted
- 18 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, double-blind, placebo-controlled study of vapendavir treatment of laboratory-confirmed and symptomatic HRV infection of the upper respiratory tract in allogeneic and autologous stem cell transplant subjects. The aim of this study is to evaluate the effect of vapendavir on laboratory-confirmed HRV upper-respiratory tract infection in HSCT patients, as measured by viral load changes, worsening of upper respiratory tract infection (URTI) to lower respiratory tract infection (LRTI), duration of clinical symptoms, the occurrence of supplemental oxygen use, duration of viral shedding, hospital admission and duration of hospitalization, incidence of secondary bacterial infection, and mortality rates. Additionally, the safety and tolerability of vapendavir, and the vapendavir plasma levels achieved in the HSCT population, and the profile of viral resistance development will also be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vapendavir 528 mg | Experimental | Drug: Vapendavir |
| Placebo | Placebo comparator | Drug: Placebo Oral Tablet |
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)
- Allogeneic or autologous HSC transplant within last 6 months using any conditioning regimen, or HSC transplant subjects with current chronic graft vs host disease requiring systemic treatment at any time point post-transplant;
- Documented HRV in the upper respiratory tract (e.g., nasal swab, nasopharyngeal swab, nasal wash) as determined by local testing;
- Subject presents to clinic reporting symptoms of a cold with the presence of at least 2 symptoms associated with HRV infection and with an onset such that they can be randomized and dosed preferably within 72 hours but up to a 5 day window (120 hours) interval from symptom onset to study treatment initiation;
- Capable of giving written informed consent that includes compliance with the requirements and restrictions listed in the consent form. Informed consent and subject assent for subjects below the legal age of consent will be documented by means of a written, signed, and dated ICF and assent document. For subjects below the legal age of consent, the parent/legal guardian will provide informed consent and subjects below the legal age of consent will provide assent to participate in the study, in compliance with local regulations;
- Subject is able to understand and comply with the protocol requirements;
Key exclusion criteria (14 listed)
- Positive test result within 5 days prior to Study Day 1 inclusive for any of the following viral respiratory pathogen that are not HRV: respiratory syncytial virus, influenza, parainfluenza, adenovirus, or human metapneumovirus;
- Clinically significant bacterial, fungal, or viral lower respiratory tract infection within 2 weeks prior to Study Day 1 (subject cannot have lower respiratory tract infection at Study Day 1) inclusive that has not been adequately treated, as determined by the investigator;
- Clinically significant systemic bacteremia or fungemia within 7 days prior to Study Day 1 that has not been adequately treated, as determined by the investigator and the Medical Monitor;
- Subjects receiving high dose systemic steroids defined as >2mg/kg per day or prednisone or prednisone equivalent currently or within the 7 days prior to Study Day 1;
- Subjects with diagnosis of a lower respiratory infection at Study Day 1, subjects with O2 saturation of less than 92% in the absence of supplemental oxygen, or those requiring invasive mechanical ventilation or non-invasive mechanical ventilation with BIPAP or CPAP at the time of randomization, and/or a history or current evidence of chronic obstructive airways disease, emphysema, cystic fibrosis or current, uncontrolled or severe asthma;
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 |
|---|---|---|
| VapendavirAlso: BTA798Vapendavir Tablets, 264 mg | Drug | Vapendavir 528 mg |
| Placebo Oral TabletVapendavir 264 mg matching tablets | Drug | Placebo |
Primary outcome
Efficacy: Time-weighted average change from baseline to end of treatment visit in HRV viral load (HRV-RNA log10 copies/mL)
Time frame: Study Day 1 to end of treatment (Study Day 14)
Safety: Proportion of treatment-emergent adverse events
Time frame: Study Day 1 - 90
Safety: Proportion of treatment-related serious adverse events
Time frame: Study Day 1 - 90
Safety: Incidence of treatment-emergent Grade 3 or greater clinical laboratory abnormalities
Time frame: Study Day 1 - 90
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2018.
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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.
Anna Novotney-Barry study director
Aviragen Therapeutics, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vapendavir in people with Rhinovirus and Upper Respiratory Tract Infection, run by Vaxart.
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 14 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: withdrawn, as of the sponsor's last update on 7 May 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Efficacy: Time-weighted average change from baseline to end of treatment visit in HRV viral load (HRV-RNA log10 copies/mL) (time frame: Study Day 1 to end of treatment (Study Day 14)). The study lists 4 primary outcomes in all. 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 7 May 2018.