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
PIV
1 other identifier
interventional
23
1 country
23
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Aug 2013
Typical duration for phase_2
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 11, 2013
CompletedStudy Start
First participant enrolled
August 1, 2013
CompletedFirst Posted
Study publicly available on registry
August 19, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2017
CompletedJuly 19, 2017
July 1, 2017
3.8 years
July 11, 2013
July 18, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Cumulative incidence and severity of AEs, SAEs, and lab abnormalities as a measure of safety and tolerability.
2 years
Secondary Outcomes (1)
Proportion of subjects with PIV viral load reduction at Day 28
2 years
Study Arms (2)
Formulation of DAS181-F02 Dry Powder in Bulk
EXPERIMENTALThe 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
EXPERIMENTALSubjects 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.
Interventions
Administered via Nebulizer
Eligibility Criteria
You may qualify if:
- 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
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
City of Hope
Duarte, California, 91010, United States
Children's Hospital of Orange County
Orange, California, 92868, United States
Stanford University Medical Center
Palo Alto, California, 94305, United States
University of Chicago
Chicago, Illinois, 60637, United States
Indiana Blood and Marrow Transplantation
Indianapolis, Indiana, 42367, United States
University of Kansas Cancer Center
Kansas City, Kansas, 66160, United States
John Hopkins University School of Medicine
Baltimore, Maryland, 21287, United States
Brigham & Women's Hospital
Boston, Massachusetts, 02115, United States
University of Minnesota, School of Medicine
Minneapolis, Minnesota, 55455, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Weill Cornell Medical College/New York Presbyterian Hospital
New York, New York, 10021, United States
Weill Cornell Medical College-Peds
New York, New York, 10065, United States
Duke University
Durham, North Carolina, 27710, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210, United States
University of Oklahoma
Oklahoma City, Oklahoma, 73104, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Seattle Children's Hospital
Seattle, Washington, 98105, United States
Fred Hutchinson Cencer Research Center
Seattle, Washington, 98109-1024, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Ron Moss, MD, CEO
Ansun Biopharma, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 11, 2013
First Posted
August 19, 2013
Study Start
August 1, 2013
Primary Completion
May 1, 2017
Study Completion
May 1, 2017
Last Updated
July 19, 2017
Record last verified: 2017-07