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 ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Ansun Biopharma, Inc.
ClinicalTrials.gov Identifier:
NCT01644877
First received: July 17, 2012
Last updated: August 2, 2016
Last verified: August 2016
  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:
  • Clinical Stability [ Time Frame: 45 days ] [ Designated as safety issue: No ]
    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)


Secondary Outcome Measures:
  • Clinical Stability [ Time Frame: 45 days ] [ Designated as safety issue: No ]
    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).

  • Mortality [ Time Frame: 45 days ] [ Designated as safety issue: No ]
    Mortality rate at Day 45

  • Clinical Stability [ Time Frame: 45 days ] [ Designated as safety issue: No ]
    Time (in days) to reach clinical stability (including survival status or excluding survival status)

  • Clinical Stability [ Time Frame: 45 days ] [ Designated as safety issue: No ]
    Time (in days) to death

  • Clinical Stability [ Time Frame: 45 days ] [ Designated as safety issue: No ]
    Time (in days) to hospital discharge of CS non-responders and death


Enrollment: 111
Study Start Date: March 2014
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (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   (Child, Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 45 Study Locations
Sponsors and Collaborators
Ansun Biopharma, Inc.
  More Information

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: August 2, 2016
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 August 23, 2016