CompletedPhase 2

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

United States23 participantsStarted 2013-08

Plain-language 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.

Who can participate

Age range12 Years

SexALL

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Inclusion criteria

✓. Age ≥12 years
✓. Able to provide informed consent or child assent with parental consent
✓. Immunocompromised, as defined by one of the following:
✓. Confirmed Parainfluenza virus by nasopharyngeal swab or tracheal aspirate for one of the following:
✓. Female subjects of child-bearing potential who are capable of conception must be:
✓. 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

What they're measuring

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

Timeframe: 2 years

Trial details

NCT IDNCT01924793

SponsorAnsun Biopharma, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-05

View on ClinicalTrials.gov More Parainfluenza trials