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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01924793
Other study ID # DAS181-2-06
Secondary ID
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
Health authority
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:

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Study Design


Related Conditions & MeSH terms


Intervention

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

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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
See also
  Status Clinical Trial Phase
Completed NCT02984280 - Specific Respiratory Infections as Triggers of Acute Medical Events N/A
Suspended NCT00186927 - A Study to Assess the Safety of Live Intranasal Sendai Virus Vaccine in Children and Toddlers Phase 1
Recruiting NCT03808922 - Phase III DAS181 Lower Tract PIV Infection in Immunocompromised Subjects (Substudy: DAS181 for COVID-19): RCT Study Phase 3
Completed NCT01644877 - A Phase II, Randomized, Double-blind, Placebo-controlled Study to Examine the Effects of DAS181 in Immunocompromised Subjects With Lower Respiratory Tract Parainfluenza Infection on Supplemental Oxygen Phase 2
Completed NCT00641017 - Safety of and Immune Response to Recombinant Live-Attenuated Parainfluenza Type 1 Virus Vaccine Phase 1