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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)

Primary Purpose

Parainfluenza

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
DAS181-F02 Dry Powder in Bulk
DAS181-F02 Nebulized Formulation Inhaled Dose
Sponsored by
Ansun Biopharma, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parainfluenza

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age ≥12 years
  2. Able to provide informed consent or child assent with parental consent

  3. 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

  4. 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).

  5. 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.

  6. Male subjects must agree to use medically accepted form of contraception during the 28 day study period.

Exclusion Criteria:

  1. Psychiatric or cognitive illness or recreational drug/alcohol use that, in the opinion of the principal investigator, would affect patient safety and/or compliance.
  2. 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.
  3. Subjects currently treated with oral, aerosolized or IV ribavirin
  4. Subjects taking any investigational drug used to research or treat PIV

Sites / Locations

  • City of Hope
  • Children's Hospital of Orange County
  • Stanford University Medical Center
  • University of Chicago
  • Indiana Blood and Marrow Transplantation
  • University of Kansas Cancer Center
  • John Hopkins University School of Medicine
  • Brigham & Women's Hospital
  • University of Minnesota, School of Medicine
  • Washington University School of Medicine
  • Hackensack University Medical Center
  • Weill Cornell Medical College/New York Presbyterian Hospital
  • Weill Cornell Medical College-Peds
  • Duke University
  • The Ohio State University Wexner Medical Center
  • University of Oklahoma
  • Hospital of the University of Pennsylvania
  • University of Pittsburgh Medical Center
  • Medical University of South Carolina
  • St. Jude Children's Research Hospital
  • The University of Texas MD Anderson Cancer Center
  • Seattle Children's Hospital
  • Fred Hutchinson Cencer Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Formulation of DAS181-F02 Dry Powder in Bulk

Nebulized Formulation Inhaled Dose

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Cumulative incidence and severity of AEs, SAEs, and lab abnormalities as a measure of safety and tolerability.

Secondary Outcome Measures

Proportion of subjects with PIV viral load reduction at Day 28

Full Information

First Posted
July 11, 2013
Last Updated
July 18, 2017
Sponsor
Ansun Biopharma, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01924793
Brief 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
Acronym
PIV
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ansun Biopharma, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parainfluenza

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Formulation of DAS181-F02 Dry Powder in Bulk
Arm Type
Experimental
Arm Description
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.
Arm Title
Nebulized Formulation Inhaled Dose
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
DAS181-F02 Dry Powder in Bulk
Intervention Description
Administered via DPI
Intervention Type
Drug
Intervention Name(s)
DAS181-F02 Nebulized Formulation Inhaled Dose
Intervention Description
Administered via Nebulizer
Primary Outcome Measure Information:
Title
Cumulative incidence and severity of AEs, SAEs, and lab abnormalities as a measure of safety and tolerability.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Proportion of subjects with PIV viral load reduction at Day 28
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ron Moss, MD, CEO
Organizational Affiliation
Ansun Biopharma, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
Children's Hospital of Orange County
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Stanford University Medical Center
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Indiana Blood and Marrow Transplantation
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
42367
Country
United States
Facility Name
University of Kansas Cancer Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
John Hopkins University School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Brigham & Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
University of Minnesota, School of Medicine
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Weill Cornell Medical College/New York Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Weill Cornell Medical College-Peds
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
The Ohio State University Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
University of Oklahoma
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
St. Jude Children's Research Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States
Facility Name
The University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Seattle Children's Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
Fred Hutchinson Cencer Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109-1024
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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