Clinical 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

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

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

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 Summary:

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.

Sponsor: Ansun Biopharma, Inc.

Current Primary Outcome: Cumulative incidence and severity of AEs, SAEs, and lab abnormalities as a measure of safety and tolerability. [ Time Frame: 2 years ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Proportion of subjects with PIV viral load reduction at Day 28 [ Time Frame: 2 years ]

Original Secondary Outcome: Same as current

Information By: Ansun Biopharma, Inc.

Dates:
Date Received: July 11, 2013
Date Started: August 2013
Date Completion:
Last Updated: May 19, 2015
Last Verified: May 2015