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History of Changes for Study: NCT01644877
Randomized, Double-blind, Placebo-controlled Phase II Study to Examine the Effects of DAS181 in Immunocompromised Patients With Parainfluenza Infection (DAS181-2-05)
Latest version (submitted September 21, 2017) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 July 18, 2012 None (earliest Version on record)
2 July 24, 2012 Recruitment Status, Study Status, Study Design and Contacts/Locations
3 February 28, 2014 Recruitment Status, Study Status, Outcome Measures, Study Identification, Contacts/Locations, Study Design, Oversight, Eligibility, Arms and Interventions and Study Description
4 April 7, 2014 Recruitment Status, Study Status and Contacts/Locations
5 April 29, 2014 Contacts/Locations and Study Status
6 May 13, 2014 Contacts/Locations and Study Status
7 June 5, 2014 Study Status and Contacts/Locations
8 May 19, 2015 Contacts/Locations and Study Status
9 July 14, 2015 Study Status, Contacts/Locations and Study Design
10 September 29, 2015 Contacts/Locations and Study Status
11 October 5, 2015 Study Status and Contacts/Locations
12 December 4, 2015 Study Status and Contacts/Locations
13 December 16, 2015 Contacts/Locations and Study Status
14 January 7, 2016 Contacts/Locations and Study Status
15 February 17, 2016 Study Status and Contacts/Locations
16 August 2, 2016 Recruitment Status, Study Status, Outcome Measures, Contacts/Locations and Study Design
17 July 18, 2017 Recruitment Status, Study Status and Contacts/Locations
18 September 21, 2017 Study Status
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Study NCT01644877
Submitted Date:  July 18, 2012 (v1)

Open or close this module Study Identification
Unique Protocol ID: DAS181-2-05
Brief Title: Randomized, Double-blind, Placebo-controlled Phase II Study to Examine the Effects of DAS181 in Immunocompromised Patients With Parainfluenza Infection (DAS181-2-05)
Official Title: Randomized, Double-blind, Placebo-controlled Phase II Study to Examine the Effects of DAS181 in Immunocompromised Patients With Parainfluenza Infection
Secondary IDs:
Open or close this module Study Status
Record Verification: July 2012
Overall Status: Not yet recruiting
Study Start: December 2012
Primary Completion: March 2014 [Anticipated]
Study Completion: October 2014 [Anticipated]
First Submitted: July 17, 2012
First Submitted that
Met QC Criteria:
July 18, 2012
First Posted: July 19, 2012 [Estimate]
Last Update Submitted that
Met QC Criteria:
July 18, 2012
Last Update Posted: July 19, 2012 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Ansun Biopharma, Inc.
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
Brief Summary: This protocol will seek to enroll immunocompromised patients diagnosed with parainfluenza infection.
Detailed Description:
Open or close this module Conditions
Conditions: Parainfluenza
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 120 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: DAS181
DAS181-F02, 10mg qd x 5 days
Drug: DAS181 dry powder, formulation F02
Placebo Comparator: Lactose Placebo Drug: Lactose Placebo
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Confirm the safety of DAS181 in the immunocompromised PIV patient population
[ Time Frame: 90 days ]

Open or close this module Eligibility
Minimum Age: 12 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Age > than or equal to 12 years, male or female;
  • Specific for LRI subjects, evidence of new parenchymal abnormalities by chest imaging
  • Able to provide informed consent or ascent
  • 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 within the past 6 months prior to screening
  • Specific for Upper Respiratory Infection subjects, a total symptom severity score of 3 or greater from one or more respiratory or non-respiratory symptoms:
    • Respiratory symptoms include rhinorrhea, hoarseness, sneezing, wheezing, sore throat, cough, earache, shortness of breath, pleuritic chest pain, hemoptysis
    • Non-respiratory symptoms include fever, chills, myalgia, malaise, arthralgia
  • Rapid culture, DFA or 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)
  • Female patients of child-bearing age who are capable of conception must meet the following criteria:
    • Have been sexually abstinent or have used contraceptive agents (oral contraceptive or other hormonal contraceptives including vaginal rings or transdermal patches, intrauterine device [IUD], or barrier methods including condoms) during the 4 weeks prior to date of screening (3 months prior to enrollment for oral/hormonal contraceptives)
    • Agree to be sexually abstinent or use contraceptive agents (oral contraceptive or other hormonal contraceptives including vaginal rings or transdermal patches, intrauterine device [IUD], or barrier methods including condoms) from the date of screening through 4 weeks after the last dose of study drug

Exclusion Criteria:

  • Mechanical ventilation that would preclude drug inhalation.
  • Current clinical evidence of a recognized or suspected uncontrolled non-PIV infectious illness with onset prior to screening.
  • Alanine aminotransferase or alkaline phosphatase greater than 5 times normal, within 30 days of screening.
  • Women who are pregnant (positive serum or urine pregnancy test), who are attempting to become pregnant, or who are breast-feeding.
  • 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.
  • Known concurrent respiratory co-infection at screening.
  • Subjects treated with oral, aerosolized or IV ribavirin.
  • Investigational drug used to research or treat PIV
  • Subjects with QTc interval > than or equal to 500msec
Open or close this module Contacts/Locations
Central Contact Person: Ronald B. Moss, M.D.
Telephone: 858-452-2631 Ext. 178
Email: rmoss@nexbio.com
Central Contact Backup: Carrie Hansen
Telephone: 858-452-2631 Ext. 172
Email: chansen@nexbio.com
Locations: United States, California
NexBio
San Diego, California, United States, 92121
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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