An Open Label Study to Examine the Effects of DAS181 Administered by Dry Powder Inhaler (DPI) or Nebulized Formulation in Immunocompromised Subjects With Parainfluenza (PIV) Infection (PIV)
This protocol will seek to enroll up to 60 immunocompromised subjects diagnosed with parainfluenza infection.
All subjects will have additional PK and Immunogenicity blood samples collected.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
The study will investigate the safety, tolerability, clinical and virologic effect of DAS1814 for the treatment of PIV infections in up to 60 immunocompromised patients with no other treatment options.
Eligible immunocompromised patients positively diagnosed with PIV infection will receive DAS181 by DPI or Nebulized formulation.
DPI: 10 mg DAS181 will be administered for seven (7) consecutive days for up to a total cumulative dose of 70mg.
Nebulized: DAS181 F02 formulation in solution will be administered for seven (7) consecutive days for up to a total cumulative dose of 28.9 mg.
Assessment of viral shedding and viral resistance testing will be performed on collected viral load samples. Blood samples will be obtained to evaluate safety at each scheduled visit.
Routine safety monitoring (including Adverse Event (AE) reporting, clinical laboratory tests, vital signs, electrocardiogram (ECG) and )2 levels) will be conducted in all subjects. A final safety assessment will occur at Day 28 (+/- 2 days) after enrollment/first dose of study drug. Survival, diary cards, and quality of life will be collected at Day 60 and 90. PK will be collected at each visit on all subjects from baseline/visit 2 to visit 11/Day 28. Immunogenicity samples will be collected at selected time points in all subjects.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Faza 2
Kontakty i lokalizacje
Lokalizacje studiów
-
-
California
-
Duarte, California, Stany Zjednoczone, 91010
- City of Hope
-
Orange, California, Stany Zjednoczone, 92868
- Children's Hospital of Orange County
-
Palo Alto, California, Stany Zjednoczone, 94305
- Stanford University Medical Center
-
-
Illinois
-
Chicago, Illinois, Stany Zjednoczone, 60637
- University of Chicago
-
-
Indiana
-
Indianapolis, Indiana, Stany Zjednoczone, 42367
- Indiana Blood and Marrow Transplantation
-
-
Kansas
-
Kansas City, Kansas, Stany Zjednoczone, 66160
- University of Kansas Cancer Center
-
-
Maryland
-
Baltimore, Maryland, Stany Zjednoczone, 21287
- John Hopkins University School of Medicine
-
-
Massachusetts
-
Boston, Massachusetts, Stany Zjednoczone, 02115
- Brigham & Women's Hospital
-
-
Minnesota
-
Minneapolis, Minnesota, Stany Zjednoczone, 55455
- University of Minnesota, School of Medicine
-
-
Missouri
-
Saint Louis, Missouri, Stany Zjednoczone, 63110
- Washington University School of Medicine
-
-
New Jersey
-
Hackensack, New Jersey, Stany Zjednoczone, 07601
- Hackensack University Medical Center
-
-
New York
-
New York, New York, Stany Zjednoczone, 10021
- Weill Cornell Medical College/New York Presbyterian Hospital
-
New York, New York, Stany Zjednoczone, 10065
- Weill Cornell Medical College-Peds
-
-
North Carolina
-
Durham, North Carolina, Stany Zjednoczone, 27710
- Duke University
-
-
Ohio
-
Columbus, Ohio, Stany Zjednoczone, 43210
- The Ohio State University Wexner Medical Center
-
-
Oklahoma
-
Oklahoma City, Oklahoma, Stany Zjednoczone, 73104
- University of Oklahoma
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Stany Zjednoczone, 19104
- Hospital of the University of Pennsylvania
-
Pittsburgh, Pennsylvania, Stany Zjednoczone, 15213
- University of Pittsburgh Medical Center
-
-
South Carolina
-
Charleston, South Carolina, Stany Zjednoczone, 29425
- Medical University of South Carolina
-
-
Tennessee
-
Memphis, Tennessee, Stany Zjednoczone, 38105
- St. Jude Children's Research Hospital
-
-
Texas
-
Houston, Texas, Stany Zjednoczone, 77030
- The University of Texas MD Anderson Cancer Center
-
-
Washington
-
Seattle, Washington, Stany Zjednoczone, 98105
- Seattle Children's Hospital
-
Seattle, Washington, Stany Zjednoczone, 98109-1024
- Fred Hutchinson Cencer Research Center
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- Age ≥12 years
- Able to provide informed consent or child assent with parental consent
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
Confirmed Parainfluenza virus by nasopharyngeal swab or tracheal aspirate for one of the following:
- Respiratory virus panel
- 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).
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 intrauterine device, spermicide, barrier, male partner surgical sterilization and hormonal contraception. A female subject must agree to practice two acceptable methods of birth control during the 28 day study period. Abstinence is not an acceptable method of contraception. 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 28 day study period.
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, ability to use the dry powder inhaler or compliance with the dosing schedule.
- Subjects currently treated with oral, aerosolized or IV ribavirin
- Subjects taking any investigational drug used to research or treat PIV
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Nielosowe
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: Formulation of DAS181-F02 Dry Powder in Bulk
The DAS181-F02 nebulized formulation includes 10mL of normal saline to prepare a liquid solution referred to as DAS181-F02 nebulized. Dry Powder Inhaled Dose: Non-ventilated subjects, capable of using a cyclohaler, will be treated by Dry Powder Inhalation. Each subject will receive a targeted daily dose of 10mg for 7 days for a total of 70mg of DAS181-F02. If a subject requires ventilation, the subject will be allowed to continue dosing following the Nebulized formulation instruction. |
Administered via DPI
|
|
Eksperymentalny: Nebulized Formulation Inhaled Dose
Subjects unable to use the Dry Powder Inhaler (as determined by site Investigator) on continuous positive airway pressure (CPAP), Bi-level positive airway pressure (BIPAP) or requiring mechanical ventilation will be treated by Nebulized formulation. The subject will remain on the nebulized formulation for the duration of the study regardless of ventilation status. DAS-F02 10 mg will be utilized to prepare the nebulized solution per the Study Reference Manual. Multiple methods (T piece, face mask, direct to ET tube) will be allowed for the nebulized dose administration. Detailed specification for nebulized dose administration will be defined in the Study Reference Manual. |
Administered via Nebulizer
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Ramy czasowe |
|---|---|
|
Cumulative incidence and severity of AEs, SAEs, and lab abnormalities as a measure of safety and tolerability.
Ramy czasowe: 2 years
|
2 years
|
Miary wyników drugorzędnych
Miara wyniku |
Ramy czasowe |
|---|---|
|
Proportion of subjects with PIV viral load reduction at Day 28
Ramy czasowe: 2 years
|
2 years
|
Współpracownicy i badacze
Sponsor
Śledczy
- Krzesło do nauki: Ron Moss, MD, CEO, Ansun Biopharma, Inc.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- DAS181-2-06
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .