Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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 (DAS181-2-05)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Ansun Biopharma, Inc.
Sponsor:
Information provided by (Responsible Party):
Ansun Biopharma, Inc.
ClinicalTrials.gov Identifier:
NCT01644877
First received: July 17, 2012
Last updated: June 5, 2014
Last verified: June 2014

July 17, 2012
June 5, 2014
March 2014
March 2015   (final data collection date for primary outcome measure)
Mortality [ Time Frame: 45 days ] [ Designated as safety issue: Yes ]
To measure the mortality rate at Day 45 in the hospitalized immunocompromised PIV infected subject population on supplemental oxygen.
Confirm the safety of DAS181 in the immunocompromised PIV patient population [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01644877 on ClinicalTrials.gov Archive Site
  • Safety and Tolerability of DAS181 [ Time Frame: 45 days ] [ Designated as safety issue: Yes ]
    To assess the safety and tolerability of DAS181 treatment in the immunocompromised PIV infection population
  • Clinical Stability [ Time Frame: 45 days ] [ Designated as safety issue: No ]
    To assess the impact of the DAS181 treatment in the immunocompromised PIV infected population on the clinical stability, use of supplemental oxygen, pulmonary function, mechanical ventilation and hospitalization
  • Viral Load [ Time Frame: 45 days ] [ Designated as safety issue: No ]
    To assess the impact of DAS181 treatment on PIV viral load, the viral load shedding and resistance.
Not Provided
Not Provided
Not Provided
 
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
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

This protocol will seek to enroll immunocompromised patients who are on supplemental oxygen and diagnosed with a parainfluenza infection.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Parainfluenza
  • Drug: DAS181 dry powder, formulation F02
  • Drug: Lactose Placebo
  • Experimental: DAS181
    DAS181-F02, 4.5 mg qd x 10 days
    Intervention: Drug: DAS181 dry powder, formulation F02
  • Placebo Comparator: Lactose Placebo
    placebo, 4.5 mg qd x 10 days
    Intervention: Drug: Lactose Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
93
April 2015
March 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age ≥12 years
  • Able to provide informed consent, child assent with parental consent or surrogate consent when applicable
  • Currently on invasive mechanical ventilation or noninvasive positive pressure ventilation (CPAP or bilevel positive airway pressure) or requiring > 2LPM supplemental oxygen therapy to maintain O2 saturation > 90% due to hypoxemia
  • Immunocompromised, as defined by one of the following: Autologous or Allogeneic hematopoietic cell transplantation (HSCT); Lung or lung-heart transplantation; Subjects treated with chemotherapy for hematologic malignancies; Subjects treated with chemotherapy for solid tumor malignancies
  • Confirmed parainfluenza at screening by one of the following methods using any sample type: Respiratory Virus Panel, Direct fluorescent antibody (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).
  • Confirmed PIV lower tract disease for subjects on mechanical ventilation will be defined as PIV detection in bronchoalveolar lavage (BAL) or biopsy within last 7 days of screening
  • Confirmed PIV lower tract disease for subjects on non-invasive positive pressure ventilation or supplemental oxygen will be defined as all of the following within the last 7 days of screening: New pulmonary infiltrate on chest imaging and at least one PIV sign and/or symptom as defined in section 10.3.6
  • 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 abstinence, intrauterine device, spermicide, barrier, male partner surgical sterilization and hormonal contraception. A female subject ≥18 years of age and of child bearing potential must agree to practice two acceptable methods of birth control during the study period. 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 study period. Abstinence is an acceptable method of contraception.

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 or compliance with the dosing schedule.
  • In the opinion of the Investigator, subjects with a low chance of survival during the first 5 days of treatment.
  • Subjects treated with oral, aerosolized or intravenous (IV) ribavirin for the treatment of PIV. A forty-eight hour (48 hr) wash out period prior to randomization is allowed.
  • Subjects with a history of RSV or MPV
  • Subjects taking any other investigational drug used to research or treat PIV.
  • Subjects with a history of allergic reactions to lactose.
  • Subjects with a history of documented Pseudomonas aeruginosa pneumonia confirmed radiographically and by culture from BAL.
Both
12 Years and older
No
Contact: Ronald B. Moss, M.D. 858-452-2631 ext 178 rmoss@ansunbiopharma.com
Contact: Carrie Hansen 858-452-2631 ext 172 chansen@ansunbiopharma.com
United States
 
NCT01644877
DAS181-2-05
Yes
Ansun Biopharma, Inc.
Ansun Biopharma, Inc.
Not Provided
Not Provided
Ansun Biopharma, Inc.
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP