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.
Verified April 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: April 7, 2014
Last verified: April 2014
  Purpose

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


Condition Intervention Phase
Parainfluenza
Drug: DAS181 dry powder, formulation F02
Drug: Lactose Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Ansun Biopharma, Inc.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 93
Study Start Date: March 2014
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DAS181
DAS181-F02, 4.5 mg qd x 10 days
Drug: DAS181 dry powder, formulation F02
Placebo Comparator: Lactose Placebo
placebo, 4.5 mg qd x 10 days
Drug: Lactose Placebo

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01644877

Contacts
Contact: Ronald B. Moss, M.D. 858-452-2631 ext 178 rmoss@nexbio.com
Contact: Carrie Hansen 858-452-2631 ext 172 chansen@nexbio.com

Locations
United States, California
City of Hope Not yet recruiting
Duarte, California, United States, 91010
Contact: Sanjeet Dadwal, MD    626-256-4673 ext 66202      
Principal Investigator: Sanjeet Dadwal, MD         
Ansun Biopharma, Inc Not yet recruiting
San Diego, California, United States, 92121
United States, Minnesota
University of Minnesota, School of Medicine Not yet recruiting
Minnesota, Minnesota, United States, 55455
Contact: Lisa Hostetler    612-624-0623    hoste005@umn.edu   
Contact: Darlette Luke    612-273-6212    dluke1@fairview.org   
Principal Investigator: Mark Schleiss         
United States, Missouri
Washington University School of Medicine Not yet recruiting
St. Louis, Missouri, United States, 63110
Contact: Steven Lawrence, MD    314-454-8225      
Principal Investigator: Steven Lawrence, MD         
United States, New Jersey
Hackensack University Medical Center Not yet recruiting
Hackensack, New Jersey, United States, 07601
Contact: Scott Rowley, MD    551-996-3872      
Principal Investigator: Scott Rowley, MD         
United States, New York
Weill Cornell Medical College/New York Presbyterian Hospital Not yet recruiting
New York, New York, United States, 10021
Contact: Rosemary Soave, MD    212-746-6319      
Principal Investigator: Rosemary Soave, MD         
United States, Ohio
Ohio State Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Lisa Hines    614-366-9385    lisa.hines@osumc.edu   
Contact: Nicole Theodoropoulos         
Principal Investigator: Stanley Martin         
United States, Texas
The University of Texas MD Anderson Cancer Center Not yet recruiting
Houston, Texas, United States, 77030
Contact: Roy Chemaly, MD    713-745-1116      
Principal Investigator: Roy Chemaly, MD         
United States, Washington
Fred Hutchinson Cencer Research Center Not yet recruiting
Seattle, Washington, United States, 98109-1024
Contact: Michael Boeckh, MD    206-667-6706      
Principal Investigator: Michael Boeckh, MD         
Sponsors and Collaborators
Ansun Biopharma, Inc.
  More Information

No publications provided

Responsible Party: Ansun Biopharma, Inc.
ClinicalTrials.gov Identifier: NCT01644877     History of Changes
Other Study ID Numbers: DAS181-2-05
Study First Received: July 17, 2012
Last Updated: April 7, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on April 23, 2014