NL-OMON43361已完成2 期
A Phase 2b, Randomized, Controlled Trial Evaluating GS 5806 in Lung Transplant (LT) Recipients with Respiratory Syncytial Virus (RSV) Infection - GS-US-218-1797
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 2
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
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 local 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
- •7) Ability and willingness to complete necessary study procedures
排除标准
- •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;
- •muromonab-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
- •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
- •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
- •17) Clinically significant liver function test abnormalities as defined by an ALT or AST
- •> 5 times the ULN obtain
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