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

Parainfluenza Clinical Trial

— DAS181-2-05  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01644877
• Other study ID #: DAS181-2-05
• Status: Completed
• Phase: Phase 2
• First received: July 17, 2012
• Last updated: September 21, 2017
• Start date: March 2014
• Est. completion date: December 15, 2016

Study information

• Verified date: September 2017
• Source: Ansun Biopharma, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: December 15, 2016
• Est. primary completion date: December 15, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Parainfluenza
• Paramyxoviridae Infections

Intervention

Drug:
• DAS181 dry powder, formulation F02

• Lactose Placebo

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Children's Hospital Colorado	Aurora	Colorado
United States	John Hopkins University School of Medicine	Baltimore	Maryland
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Brigham & Women's Hospital	Boston	Massachusetts
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Lurie Children's Hospital	Chicago	Illinois
United States	University of Chicago	Chicago	Illinois
United States	Cincinnati Children's Hospital	Cincinnati	Ohio
United States	Cleveland Clinic	Cleveland	Ohio
United States	Nationwide Children's	Columbus	Ohio
United States	City of Hope	Duarte	California
United States	Duke University Medical Center	Durham	North Carolina
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	Baylor College of Medicine	Houston	Texas
United States	Texas Children's Hospital	Houston	Texas
United States	The University of Texas MD Anderson Cancer Center	Houston	Texas
United States	Indiana Blood and Marrow Transplantation	Indianapolis	Indiana
United States	University of Iowa	Iowa City	Iowa
United States	Children's Mercy Hospital	Kansas City	Kansas
United States	University of Kansas	Kansas City	Kansas
United States	Loyola University Medical Center	Maywood	Illinois
United States	St. Jude Children's Research Hospital	Memphis	Tennessee
United States	University of Minnesota, School of Medicine	Minnesota City	Minnesota
United States	Vanderbilt- Henry-Joyce Cancer Clinic	Nashville	Tennessee
United States	Weill Cornell Medical College-Peds	New York	New York
United States	Weill Cornell Medical College/New York Presbyterian Hospital	New York	New York
United States	University of Oklahoma	Oklahoma City	Oklahoma
United States	Children's Hospital of Orange County	Orange	California
United States	Stanford University Medical Center	Palo Alto	California
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Mayo Clinic-Arizona	Phoenix	Arizona
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Virginia Commonwealth	Richmond	Virginia
United States	University of Rochester Medical Center	Rochester	New York
United States	UC Davis	Sacramento	California
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	University of Utah	Salt Lake City	Utah
United States	Ansun Biopharma, Inc	San Diego	California
United States	Fred Hutchinson Cencer Research Center	Seattle	Washington
United States	Seattle Children's Hospital	Seattle	Washington
United States	University of Washington Medical Center	Seattle	Washington
United States	Stonybrook	Stony Brook	New York
United States	Montefiore Medical Center	The Bronx	New York

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	Clinical Stability	Clinical stability survival (CSS) rate is defined as subjects who meet the clinical stability criteria and are alive at Study Day 45 (Responders) compared to those who have not met clinical stability criteria or have expired regardless of stability status (Non-responders)	45 days
Secondary	Clinical Stability	Clinical stability (CS) rate excluding survival status: Clinical stability (CS) rate is defined as subjects who reached clinical stability criteria (Responders) compared to those subjects who did not meet the clinical stability criteria (Non-responders).	45 days
Secondary	Mortality	Mortality rate at Day 45	45 days
Secondary	Clinical Stability	Time (in days) to reach clinical stability (including survival status or excluding survival status)	45 days
Secondary	Clinical Stability	Time (in days) to death	45 days
Secondary	Clinical Stability	Time (in days) to hospital discharge of CS non-responders and death	45 days