EUCTR2018-004318-16-DK进行中（未招募）1 期
A Phase III Randomized Placebo-Controlled Study to Examine the Efficacy and Safety of DAS181 for the Treatment of Lower Respiratory Tract Parainfluenza Infection in Immunocompromised Subjects - STOP PIV - Phase III DAS181 Lower Tract PIV Infection in Immunocompromised Subjects
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 192
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Subjects must meet all of the following inclusion criteria to be eligible for participation in this study:
- •1. Requires, at the time of randomization, supplemental oxygen =2 LPM due to hypoxemia, defined by meeting at least one of the following criteria:
- •- SpO2 <92% on or off supplemental oxygen
- •- mechanical or non-invasive ventilation (CPAP or Bi-PAP)
- •- Written declaration from Investigator that subject is clinically hypoxemic and removal of oxygen supplementation would not be considered clinically appropriate for the purpose of measuring SpO2 while on room air
- •Note: Documentation of hypoxemia prior to or during the most recent oxygen supplementation must be available in source documents.
- •Note: Subjects who also require invasive mechanical ventilation (MV) or non-invasive positive pressure ventilation (CPAP or bi-PAP) are eligible, although ventilator support is not mandatory
- •2. Immunocompromised, as defined by one or more of the following:
- •- Received an autologous or allogeneic hematopoietic stem cell transplantation (HSCT) at any time in the past
- •- Received a solid organ transplant at any time in the past
- •- Has been or is currently being treated with chemotherapy for hematologic malignancies (e.g., leukemia, myeloma, lymphoma) and/or solid tumor malignancies (e.g., lung, breast, brain cancer) at any time in the past
- •- Has an immunodeficiency due to congenital abnormality (only applicable to subjects age < 18 years old) or pre-term birth (only applicable to subjects age = 2 years old)
- •3. Has, within 3 days prior to randomization, a confirmed LRTI with a sialic acid dependent respiratory virus (SAD-RV, see definition). This can be confirmed by:
- •- bronchoalveolar lavage (BAL) positive for SAD-RV
- •- lung biopsy positive for SAD-RV
- •- chest imaging with a new or worsening finding of pulmonary infiltrate, bronchiolitis, or pneumonitis temporally associated with an upper respiratory tract sample (e.g., tracheal aspirate, sputum, nasopharyngeal swab (NPS), nasopharyngeal wash) positive for SAD-RV
- •Note: These requirements can be fulfilled by results from samples and/or chest imaging that are collected/performed locally as per standard of care within 3 days prior to randomization.
- •Note: For all subjects, after obtaining informed consent but within 3 days prior to randomization, a separate nasopharyngeal swab sample will be collected and sent to the central laboratory for confirmation of a SAD-RV. The results from the central lab analysis are not required to initiate the subject on study treatment.
- •4. If female, subject must meet one of the following conditions:
- •- Not be of childbearing potential, defined as one or more of the following conditions:
- •-Premenarchal
- •-Postmenopausal for at least 1 year
- •-Surgically sterile due to bilateral tubal ligation, bilateral oophorectomy, or hysterectomy;
- •- Be of childbearing potential and meet all of the following criteria:
- •-Has a negative urine or serum pregnancy test (beta-human chorionic gonadotropin) at screening
- •-Agrees to practice an acceptable method of contraception (or meets criteria for waiving contraception) from screening until at least 30 days after last dose of study medication (see Section 8.10.1) for details)
- •Note: Additional contraception requirements may need to be followed according to local regulations and/or requirements.
- •5. Non-vasectomized males are required to practice effective birth control methods (see Section 8.10.1) from screening until at
排除标准
- •Subjects who meet any of the following exclusion criteria will not be enrolled in this study:
- •1. Subjects may not be on hospice care or, in the opinion of the investigator, have a low chance of survival during the first 10 days of treatment
- •2. Subjects with Alanine Aminotransferase (ALT), Aspartate
- •Aminotransferase (AST), or Alkaline Phosphatase (ALP) =3x ULN and
- •Total Bilirubin (TBILI) =2x ULN.
- •Note: Subjects with ALT/AST/ALP = 3x ULN and TBILI =2x ULN that
- •have been chronically stable (for >1 year on more than one assessment)
- •due to known liver pathology including malignancy (primary or
- •metastasis), chronic medications, transplantation, or chronic infection
- •will not be excluded
- •3. Female subjects breastfeeding or planning to breastfeed at any time
- •through 30 days after the last dose of study drug
- •4. Subjects taking any other investigational drugs used to treat pulmonary infection.
- •5. Psychiatric or cognitive illness or recreational drug/alcohol use that, in the opinion of the principal investigator, would affect subject safety and/or compliance
- •6. Subjects with known hypersensitivity to DAS181 and/or any of its components
- •7. Subjects with severe sepsis due to either their baseline SAD-RV infection or a concurrent viral, bacterial, or fungal infection and meet at least one of the following criteria:
- •? Has evidence of vital organ failure outside of the lung (e.g., liver,
- •kidney), or
- •? Requires vasopressors to maintain blood pressure
研究者
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