ParainfluenzaPhase 2PIVNCT01924793
An Open Label Study to Examine the Effects of DAS181 Administered by Dry Powder Inhaler (DPI) or Nebulized Formulation in Immunocompromised Subjects With Parainfluenza (PIV) Infection
A Phase 2 study testing DAS181-F02 Dry Powder in Bulk and DAS181-F02 Nebulized Formulation Inhaled Dose in people with Parainfluenza, run by Ansun Biopharma, Inc. at 23 sites in United States.
Trial summary
This protocol will seek to enroll up to 60 immunocompromised subjects diagnosed with parainfluenza infection. All subjects will have additional PK and Immunogenicity blood samples collected. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Parainfluenza
- What is being tested?
- DAS181-F02 Dry Powder in Bulk and DAS181-F02 Nebulized Formulation Inhaled Dose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 23 sitesUnited States
- Study dates
- Aug 2013to May 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age ≥12 years
- Able to provide informed consent or child assent with parental consent
- Immunocompromised, as defined by one of the following:
- Allogeneic hematopoietic cell transplantation (HCT)
- Lung or lung-heart transplantation
- Patients treated with chemotherapy for hematologic malignancies or autologous HCT
Show all 13Show fewer
- Confirmed Parainfluenza virus by nasopharyngeal swab or tracheal aspirate for one of the following:
- Respiratory virus panel
- DFA
- Qualitative/quantitative RT-PCR test for parainfluenza virus performed at the local laboratory (a confirmatory PCR test will be done at the central lab but is not required to start the patient on study).
- Female subjects of child-bearing potential who are capable of conception must be:
- post-menopausal (one year or greater without menses), surgically incapable of childbearing, or practicing two effective methods of birth control. Acceptable methods include intrauterine device, spermicide, barrier, male partner surgical sterilization and hormonal contraception. A female subject must agree to practice two acceptable methods of birth control during the 28 day study period. Abstinence is not an acceptable method of contraception. All reproductive female subjects must have a negative serum pregnancy test during the screening visit.
- Male subjects must agree to use medically accepted form of contraception during the 28 day study period.
Who cannot join
- Psychiatric or cognitive illness or recreational drug/alcohol use that, in the opinion of the principal investigator, would affect patient safety and/or compliance.
- Any significant finding in the patient's medical history or physical examination that, in the opinion of the investigator, would affect patient safety, ability to use the dry powder inhaler or compliance with the dosing schedule.
- Subjects currently treated with oral, aerosolized or IV ribavirin
- Subjects taking any investigational drug used to research or treat PIV
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
John Hopkins University School of Medicine
Baltimore, Maryland, 21287
Brigham & Women's Hospital
Boston, Massachusetts, 02115
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Chicago
Chicago, Illinois, 60637
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
City of Hope
Duarte, California, 91010
Duke University
Durham, North Carolina, 27710
Hackensack University Medical Center
Hackensack, New Jersey, 07601
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Indiana Blood and Marrow Transplantation
Indianapolis, Indiana, 42367
University of Kansas Cancer Center
Kansas City, Kansas, 66160
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
University of Minnesota, School of Medicine
Minneapolis, Minnesota, 55455
Weill Cornell Medical College/New York Presbyterian Hospital
New York, New York, 10021
Weill Cornell Medical College-Peds
New York, New York, 10065
University of Oklahoma
Oklahoma City, Oklahoma, 73104
Children's Hospital of Orange County
Orange, California, 92868
Stanford University Medical Center
Palo Alto, California, 94305
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Seattle Children's Hospital
Seattle, Washington, 98105
Fred Hutchinson Cencer Research Center
Seattle, Washington, 98109-1024
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
This protocol will seek to enroll up to 60 immunocompromised subjects diagnosed with parainfluenza infection.
All subjects will have additional PK and Immunogenicity blood samples collected.
Read the detailed description
The study will investigate the safety, tolerability, clinical and virologic effect of DAS1814 for the treatment of PIV infections in up to 60 immunocompromised patients with no other treatment options.
Eligible immunocompromised patients positively diagnosed with PIV infection will receive DAS181 by DPI or Nebulized formulation.
DPI: 10 mg DAS181 will be administered for seven (7) consecutive days for up to a total cumulative dose of 70mg.
Nebulized: DAS181 F02 formulation in solution will be administered for seven (7) consecutive days for up to a total cumulative dose of 28.9 mg.
Assessment of viral shedding and viral resistance testing will be performed on collected viral load samples. Blood samples will be obtained to evaluate safety at each scheduled visit.
Routine safety monitoring (including Adverse Event (AE) reporting, clinical laboratory tests, vital signs, electrocardiogram (ECG) and )2 levels) will be conducted in all subjects. A final safety assessment will occur at Day 28 (+/- 2 days) after enrollment/first dose of study drug. Survival, diary cards, and quality of life will be collected at Day 60 and 90. PK will be collected at each visit on all subjects from baseline/visit 2 to visit 11/Day 28. Immunogenicity samples will be collected at selected time points in all subjects.
- Conditions
- Parainfluenza
- Being tested
- DAS181-F02 Dry Powder in Bulk, DAS181-F02 Nebulized Formulation Inhaled Dose
- Medical subject headings
- Paramyxoviridae Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DAS181-F02 Dry Powder in BulkDrug
Administered via DPI
DAS181-F02 Nebulized Formulation Inhaled DoseDrug
Administered via Nebulizer
| Study group | Role | What they receive |
|---|---|---|
| Formulation of DAS181-F02 Dry Powder in Bulk | Experimental | The DAS181-F02 nebulized formulation includes 10mL of normal saline to prepare a liquid solution referred to as DAS181-F02 nebulized.
Dry Powder Inhaled Dose:
Non-ventilated subjects, capable of using a cyclohaler, will be treated by Dry Powder Inhalation. Each subject will receive a targeted daily dose of 10mg for 7 days for a total of 70mg of DAS181-F02. If a subject requires ventilation, the subject will be allowed to continue dosing following the Nebulized formulation instruction. Receives: Drug: DAS181-F02 Dry Powder in Bulk |
| Nebulized Formulation Inhaled Dose | Experimental | Subjects unable to use the Dry Powder Inhaler (as determined by site Investigator) on continuous positive airway pressure (CPAP), Bi-level positive airway pressure (BIPAP) or requiring mechanical ventilation will be treated by Nebulized formulation. The subject will remain on the nebulized formulation for the duration of the study regardless of ventilation status. DAS-F02 10 mg will be utilized to prepare the nebulized solution per the Study Reference Manual.
Multiple methods (T piece, face mask, direct to ET tube) will be allowed for the nebulized dose administration. Detailed specification for nebulized dose administration will be defined in the Study Reference Manual. Receives: Drug: DAS181-F02 Nebulized Formulation Inhaled Dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative incidence and severity of AEs, SAEs, and lab abnormalities as a measure of safety and tolerability.
Measured: 2 years
Secondary outcomes (1)
Proportion of subjects with PIV viral load reduction at Day 28
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParainfluenzaStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ansun Biopharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ron Moss, MD, CEO, Study chair, Ansun Biopharma, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01924793
- Sponsor's protocol ID
- DAS181-2-06
- Acronym
- PIV
- Status last verified
- Jul 2017
- First submitted
- 11 Jul 2013
- Last updated
- 19 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Study to Examine the Effects of DAS181 Administered by Dry Powder Inhaler (DPI) or Nebulized Formulation in Immunocompromised Subjects With Parainfluenza (PIV) Infection
- ClinicalTrials.gov ID
- NCT01924793
- Acronym / sponsor ID
- PIV / DAS181-2-06
- Conditions
- Parainfluenza
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Ansun Biopharma, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 19 Aug 2013 (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 protocol will seek to enroll up to 60 immunocompromised subjects diagnosed with parainfluenza infection.
All subjects will have additional PK and Immunogenicity blood samples collected.
Detailed description
The study will investigate the safety, tolerability, clinical and virologic effect of DAS1814 for the treatment of PIV infections in up to 60 immunocompromised patients with no other treatment options.
Eligible immunocompromised patients positively diagnosed with PIV infection will receive DAS181 by DPI or Nebulized formulation.
DPI: 10 mg DAS181 will be administered for seven (7) consecutive days for up to a total cumulative dose of 70mg.
Nebulized: DAS181 F02 formulation in solution will be administered for seven (7) consecutive days for up to a total cumulative dose of 28.9 mg.
Assessment of viral shedding and viral resistance testing will be performed on collected viral load samples. Blood samples will be obtained to evaluate safety at each scheduled visit.
Routine safety monitoring (including Adverse Event (AE) reporting, clinical laboratory tests, vital signs, electrocardiogram (ECG) and )2 levels) will be conducted in all subjects. A final safety assessment will occur at Day 28 (+/- 2 days) after enrollment/first dose of study drug. Survival, diary cards, and quality of life will be collected at Day 60 and 90. PK will be collected at each visit on all subjects from baseline/visit 2 to visit 11/Day 28. Immunogenicity samples will be collected at selected time points in all subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Formulation of DAS181-F02 Dry Powder in Bulk | Experimental | Drug: DAS181-F02 Dry Powder in BulkThe DAS181-F02 nebulized formulation includes 10mL of normal saline to prepare a liquid solution referred to as DAS181-F02 nebulized. Dry Powder Inhaled Dose: Non-ventilated subjects, capable of using a cyclohaler, will be treated by Dry Powder Inhalation. Each subject will receive a targeted daily dose of 10mg for 7 days for a total of 70mg of DAS181-F02. If a subject requires ventilation, the subject will be allowed to continue dosing following the Nebulized formulation instruction. |
| Nebulized Formulation Inhaled Dose | Experimental | Drug: DAS181-F02 Nebulized Formulation Inhaled DoseSubjects unable to use the Dry Powder Inhaler (as determined by site Investigator) on continuous positive airway pressure (CPAP), Bi-level positive airway pressure (BIPAP) or requiring mechanical ventilation will be treated by Nebulized formulation. The subject will remain on the nebulized formulation for the duration of the study regardless of ventilation status. DAS-F02 10 mg will be utilized to prepare the nebulized solution per the Study Reference Manual. Multiple methods (T piece, face mask, direct to ET tube) will be allowed for the nebulized dose administration. Detailed specification for nebulized dose administration will be defined in the Study Reference Manual. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- Age ≥12 years
- Able to provide informed consent or child assent with parental consent
- Immunocompromised, as defined by one of the following:
- Confirmed Parainfluenza virus by nasopharyngeal swab or tracheal aspirate for one of the following:
- Female subjects of child-bearing potential who are capable of conception must be:
Key exclusion criteria (4 listed)
- Psychiatric or cognitive illness or recreational drug/alcohol use that, in the opinion of the principal investigator, would affect patient safety and/or compliance.
- Any significant finding in the patient's medical history or physical examination that, in the opinion of the investigator, would affect patient safety, ability to use the dry powder inhaler or compliance with the dosing schedule.
- Subjects currently treated with oral, aerosolized or IV ribavirin
- Subjects taking any investigational drug used to research or treat PIV
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 |
|---|---|---|
| DAS181-F02 Dry Powder in BulkAdministered via DPI | Drug | Formulation of DAS181-F02 Dry Powder in Bulk |
| DAS181-F02 Nebulized Formulation Inhaled DoseAdministered via Nebulizer | Drug | Nebulized Formulation Inhaled Dose |
Primary outcome
Cumulative incidence and severity of AEs, SAEs, and lab abnormalities as a measure of safety and tolerability.
Time frame: 2 years
1 secondary outcome
Proportion of subjects with PIV viral load reduction at Day 28
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2017.
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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.
Ron Moss, MD, CEO study chair
Ansun Biopharma, Inc.
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DAS181-F02 Dry Powder in Bulk and DAS181-F02 Nebulized Formulation Inhaled Dose in people with Parainfluenza, run by Ansun Biopharma, Inc. at 23 sites in United States.
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 13 inclusion and 4 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: finished, as of the sponsor's last update on 19 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cumulative incidence and severity of AEs, SAEs, and lab abnormalities as a measure of safety and tolerability. (time frame: 2 years). 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 19 Jul 2017.