EUCTR2015-002287-16-NL进行中（未招募）1 期
A Phase 2b, Randomized, Controlled Trial Evaluating GS-5806 in Lung Transplant (LT) Recipients with Respiratory Syncytial Virus (RSV) Infection
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
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
- •1) Males and females = 18 years of age who have received a LT (single or double) or heart/lung transplant > 90 days prior to Screening
- •2) Confirmed to be RSV-positive by local polymerase chain reaction (PCR) testing (starting from when the upper or lower respiratory tract sample is obtained) = 7 days prior to IMP administration on Day 1/Baseline
- •3) New onset or acute worsening, if the symptom is chronic, of at least 1 of the following respiratory symptoms = 7 days prior to IMP administration on Day 1/Baseline: nasal congestion, earache, runny nose, cough, sore throat, shortness of breath, or wheezing
- •4) An informed consent document signed and dated by the subject
- •5) A negative urine or serum pregnancy test for female subjects of childbearing potential at Screening within 1 day prior to IMP administration. When available, existing local pregnancy test results obtained prior to Screening may be used, provided the testing was completed within 1 day prior to IMP administration
- •6) Agreement from male and female subjects of childbearing potential who engage in heterosexual intercourse to use protocol specified method(s) of contraception as described in Appendix 6
- •7) Ability and willingness to complete necessary study procedures
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 45
排除标准
- •Related to concomitant or previous medication use:
- •1) Use of any non-marketed (according to region) investigational agents within 30 days, OR use of any investigational monoclonal anti-RSV antibodies within 4 months or 5 half-lives of Screening, whichever is longer, OR use of any prior investigational RSV vaccines
- •2) Use of a strong or moderate cytochrome P450 enzyme (CYP) inducer including but not limited to rifampin, St. John’s Wort, carbamazepine, phenytoin, efavirenz, bosentan, etravirine, modafinil, and nafcillin, within 2 weeks prior to the first dose of IMP
- •3) Use of any of the following lympholytic treatment within the stated time frame: anti-thymocyte globulin (ATG), < 3 months; anti-lymphoblast globulin (ALG), < 3 months; muronomab-CD3 (OKT3), < 3 months; rituximab < 6 months; alemtuzumab < 9 months
- •Related to transplant history:
- •4) Recipient of any other organ transplant prior to Screening, with the exception of a LT (single or double) or heart/lung transplant
- •5) Recipient of a hematopoietic cell transplant at any time
- •6) Presence of BOS Stage 3 at Screening defined as a FEV1 of 50% or less of baseline
- •Related to medical condition at Screening:
- •7) Respiratory failure requiring invasive mechanical ventilation
- •8) Evidence of shock requiring vasopressors
- •9) Known viral coinfection (including but not limited to influenza, metapneumovirus, human rhinovirus, parainfluenza, cytomegalovirus, or coronavirus) in the upper or lower respiratory tract = 14 days prior to Screening unless discussed with the medical monitor and deemed acceptable
- •10) Active systemic infection or infectious pneumonia of any etiology (ie, bacterial, viral [other than RSV] or fungal), including aspiration pneumonia, that is considered clinically significant by the investigator unless discussed with the medical monitor and deemed acceptable
- •11) Pregnant or lactating females
- •12) Evidence of recent and rapidly deteriorating lung function, occurring before the onset of the current viral respiratory infection, including but not limited to: acute lung allograft rejection, rapidly-progressive CLAD, and rCLAD (as determined by the investigator)
- •13) Any condition which, in the opinion of the investigator, would prevent full participation in this study or would interfere with the evaluation of the trial endpoints
- •Related to allergies:
- •14) Known hypersensitivity or allergy to the IMP, its metabolites, or formulation excipients (microcrystalline cellulose, mannitol, croscarmellose sodium, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol and talc)
- •15) History of hypersensitivity, anaphylactic reaction, Stevens-Johnson Syndrome, or toxic epidermal necroylsis response to sulfa drugs
- •Related to laboratory values:
- •16) Clinically significant kidney dysfunction as defined by:
- •An estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 as calculated by the Modification of Diet in Renal Disease (MDRD) study 4 parameter equation obtained from screening laboratory measurements or via local laboratory measurements obtained = 7 days prior to Screening. The eGFR may be manually calculated or the reported eGFR value may be used, but any automatically calculated eGFR must be calculated using the MDRD equation.
- •17) Clinically significant liver function test abnormalities as defined by a ALT or AST > 5 times the ULN obtained in screening laboratory measurements or via local laboratory measurements obtained = 7 days prior to Screening
研究者
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