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.
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
-
-
California
-
Duarte、California、アメリカ、91010
- City of Hope
-
Orange、California、アメリカ、92868
- Children's Hospital of Orange County
-
Palo Alto、California、アメリカ、94305
- Stanford University Medical Center
-
-
Illinois
-
Chicago、Illinois、アメリカ、60637
- University of Chicago
-
-
Indiana
-
Indianapolis、Indiana、アメリカ、42367
- Indiana Blood and Marrow Transplantation
-
-
Kansas
-
Kansas City、Kansas、アメリカ、66160
- University of Kansas Cancer Center
-
-
Maryland
-
Baltimore、Maryland、アメリカ、21287
- John Hopkins University School of Medicine
-
-
Massachusetts
-
Boston、Massachusetts、アメリカ、02115
- Brigham & Women's Hospital
-
-
Minnesota
-
Minneapolis、Minnesota、アメリカ、55455
- University of Minnesota, School of Medicine
-
-
Missouri
-
Saint Louis、Missouri、アメリカ、63110
- Washington University School of Medicine
-
-
New Jersey
-
Hackensack、New Jersey、アメリカ、07601
- Hackensack University Medical Center
-
-
New York
-
New York、New York、アメリカ、10021
- Weill Cornell Medical College/New York Presbyterian Hospital
-
New York、New York、アメリカ、10065
- Weill Cornell Medical College-Peds
-
-
North Carolina
-
Durham、North Carolina、アメリカ、27710
- Duke University
-
-
Ohio
-
Columbus、Ohio、アメリカ、43210
- The Ohio State University Wexner Medical Center
-
-
Oklahoma
-
Oklahoma City、Oklahoma、アメリカ、73104
- University of Oklahoma
-
-
Pennsylvania
-
Philadelphia、Pennsylvania、アメリカ、19104
- Hospital of the University of Pennsylvania
-
Pittsburgh、Pennsylvania、アメリカ、15213
- University of Pittsburgh Medical Center
-
-
South Carolina
-
Charleston、South Carolina、アメリカ、29425
- Medical University of South Carolina
-
-
Tennessee
-
Memphis、Tennessee、アメリカ、38105
- St. Jude Children's Research Hospital
-
-
Texas
-
Houston、Texas、アメリカ、77030
- The University of Texas MD Anderson Cancer Center
-
-
Washington
-
Seattle、Washington、アメリカ、98105
- Seattle Children's Hospital
-
Seattle、Washington、アメリカ、98109-1024
- Fred Hutchinson Cencer Research Center
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：非ランダム化
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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
|
|
実験的：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
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Cumulative incidence and severity of AEs, SAEs, and lab abnormalities as a measure of safety and tolerability.
時間枠：2 years
|
2 years
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Proportion of subjects with PIV viral load reduction at Day 28
時間枠：2 years
|
2 years
|
協力者と研究者
スポンサー
捜査官
- スタディチェア：Ron Moss, MD, CEO、Ansun Biopharma, Inc.
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- DAS181-2-06
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。