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.
Обзор исследования
Статус
Условия
Подробное описание
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.
Тип исследования
Регистрация (Действительный)
Фаза
- Фаза 2
Контакты и местонахождение
Места учебы
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California
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Duarte, California, Соединенные Штаты, 91010
- City of Hope
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Orange, California, Соединенные Штаты, 92868
- Children's Hospital of Orange County
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Palo Alto, California, Соединенные Штаты, 94305
- Stanford University Medical Center
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Illinois
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Chicago, Illinois, Соединенные Штаты, 60637
- University of Chicago
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Indiana
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Indianapolis, Indiana, Соединенные Штаты, 42367
- Indiana Blood and Marrow Transplantation
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Kansas
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Kansas City, Kansas, Соединенные Штаты, 66160
- University of Kansas Cancer Center
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Maryland
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Baltimore, Maryland, Соединенные Штаты, 21287
- John Hopkins University School of Medicine
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Massachusetts
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Boston, Massachusetts, Соединенные Штаты, 02115
- Brigham & Women's Hospital
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Minnesota
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Minneapolis, Minnesota, Соединенные Штаты, 55455
- University of Minnesota, School of Medicine
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Missouri
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Saint Louis, Missouri, Соединенные Штаты, 63110
- Washington University School of Medicine
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New Jersey
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Hackensack, New Jersey, Соединенные Штаты, 07601
- Hackensack University Medical Center
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New York
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New York, New York, Соединенные Штаты, 10021
- Weill Cornell Medical College/New York Presbyterian Hospital
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New York, New York, Соединенные Штаты, 10065
- Weill Cornell Medical College-Peds
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North Carolina
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Durham, North Carolina, Соединенные Штаты, 27710
- Duke University
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Ohio
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Columbus, Ohio, Соединенные Штаты, 43210
- The Ohio State University Wexner Medical Center
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Oklahoma
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Oklahoma City, Oklahoma, Соединенные Штаты, 73104
- University of Oklahoma
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Pennsylvania
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Philadelphia, Pennsylvania, Соединенные Штаты, 19104
- Hospital of the University of Pennsylvania
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Pittsburgh, Pennsylvania, Соединенные Штаты, 15213
- University of Pittsburgh Medical Center
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South Carolina
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Charleston, South Carolina, Соединенные Штаты, 29425
- Medical University of South Carolina
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Tennessee
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Memphis, Tennessee, Соединенные Штаты, 38105
- St. Jude Children's Research Hospital
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Texas
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Houston, Texas, Соединенные Штаты, 77030
- The University of Texas MD Anderson Cancer Center
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Washington
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Seattle, Washington, Соединенные Штаты, 98105
- Seattle Children's Hospital
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Seattle, Washington, Соединенные Штаты, 98109-1024
- Fred Hutchinson Cencer Research Center
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
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
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Нерандомизированный
- Интервенционная модель: Одногрупповое задание
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: 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
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Экспериментальный: 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
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Временное ограничение |
|---|---|
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Cumulative incidence and severity of AEs, SAEs, and lab abnormalities as a measure of safety and tolerability.
Временное ограничение: 2 years
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2 years
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Вторичные показатели результатов
Мера результата |
Временное ограничение |
|---|---|
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Proportion of subjects with PIV viral load reduction at Day 28
Временное ограничение: 2 years
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2 years
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Соавторы и исследователи
Спонсор
Следователи
- Учебный стул: Ron Moss, MD, CEO, Ansun Biopharma, Inc.
Даты записи исследования
Изучение основных дат
Начало исследования
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оценивать)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- DAS181-2-06
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .