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

Parainfluenza Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01924793
• Other study ID #: DAS181-2-06
• Status: Completed
• Phase: Phase 2
• First received: July 11, 2013
• Last updated: July 18, 2017
• Start date: August 2013
• Est. completion date: May 2017

Study information

• Verified date: July 2017
• Source: Ansun Biopharma, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Parainfluenza
• Paramyxoviridae Infections

Intervention

Drug:
• DAS181-F02 Dry Powder in Bulk
Administered via DPI
• DAS181-F02 Nebulized Formulation Inhaled Dose
Administered via Nebulizer

Locations

Country	Name	City	State
United States	John Hopkins University School of Medicine	Baltimore	Maryland
United States	Brigham & Women's Hospital	Boston	Massachusetts
United States	Medical University of South Carolina	Charleston	South Carolina
United States	University of Chicago	Chicago	Illinois
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio
United States	City of Hope	Duarte	California
United States	Duke University	Durham	North Carolina
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	The University of Texas MD Anderson Cancer Center	Houston	Texas
United States	Indiana Blood and Marrow Transplantation	Indianapolis	Indiana
United States	University of Kansas Cancer Center	Kansas City	Kansas
United States	St. Jude Children's Research Hospital	Memphis	Tennessee
United States	University of Minnesota, School of Medicine	Minneapolis	Minnesota
United States	Weill Cornell Medical College-Peds	New York	New York
United States	Weill Cornell Medical College/New York Presbyterian Hospital	New York	New York
United States	University of Oklahoma	Oklahoma City	Oklahoma
United States	Children's Hospital of Orange County	Orange	California
United States	Stanford University Medical Center	Palo Alto	California
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Fred Hutchinson Cencer Research Center	Seattle	Washington
United States	Seattle Children's Hospital	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Ansun Biopharma, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative incidence and severity of AEs, SAEs, and lab abnormalities as a measure of safety and tolerability.		2 years
Secondary	Proportion of subjects with PIV viral load reduction at Day 28		2 years