EUCTR2014-002474-36-DE进行中（未招募）1 期
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Multi-Center Study Evaluating Antiviral Effects, Pharmacokinetics, Safety, and Tolerability of GS-5806 in Hematopoietic Cell Transplant (HCT) Recipients with Respiratory Syncytial Virus (RSV) Infection of the Upper Respiratory Tract.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 200
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. Adult male and female subjects 18 to 75 years of age. In Japan
- •subjects must be 20 to 75 years of age. In Singapore subjects must be
- •21 to 75 years of age
- •2. Received an autologous or allogeneic HCT using any conditioning
- •3. Documented to be RSV-positive as determined by local testing (eg,
- •PCR, DFA, RVP assay, or culture) using an upper respiratory tract sample
- •collected = 6 days prior to Day 1 or as determined at Screening as per Section 6.1.1
- •4. New onset of at least 1 of the following respiratory symptoms for = 7
- •days prior to Day 1: nasal congestion, runny nose, cough, or sore throat,
- •or worsening of one of these chronic (associated with a previously
- •existing diagnosis, eg, chronic rhinorrhea, seasonal allergies, chronic
- •lung disease) respiratory symptoms = 7 days prior to Day 1
- •5. No evidence of new abnormalities consistent with LRTI on a chest Xray
- •relative to the most recent chest X-ray, as determined by the local
- •radiologist. If a chest X-ray is not available or was not obtained during
- •standard care < 48 hours prior to Screening, a chest X-ray must be
- •obtained for Screening
- •6. O2 saturation = 92% on room air
- •7. An informed consent document signed and dated by the subject or a
- •legal guardian of the subject and the investigator or his/her designee. In
- •Sweden ICFs signed by a legal guardian must also be signed by a close
- •relative of the subject
- •8. A negative urine or serum pregnancy test is required for female
- •subjects (unless surgically sterile or greater than two years postXML
- •File Identifier: uTJrJoSmpFLIfUvCfdETFRFxWC4=
- •menopausal)
- •9. Male and female subjects of childbearing potential must agree to
- •contraceptive requirements as described in Appendix 5
- •10. Willingness to complete necessary study procedures and have
- •available a working telephone or email
- •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 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 150
排除标准
- •Related to concomitant or previous medication use:
- •1. Use of 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 investigational RSV vaccines after HCT.
- •2. Use of a moderate or strong 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
- •Related to medical history:
- •3. Admitted to the hospital primarily for a lower respiratory tract disease
- •of any cause as determined by the investigator
- •4. Pregnant, breastfeeding, or lactating females
- •5. Unable to tolerate nasal sampling required for this study, as
- •determined by the investigator
- •6. Known history of HIV/AIDS with a CD4 count <200 cells/µL within the
- •7. History of drug and/or alcohol abuse that, in the opinion of the
- •investigator, may prevent adherence to study activities
- •Related to medical condition at Screening:
- •8. Documented to be positive for other respiratory viruses (limited to
- •influenza, parainfluenza, human rhinovirus, adenovirus, human
- •metapneumovirus, or coronavirus) within 7 days prior to the Screening
- •visit, as determined by local testing (additional testing is not required)
- •9. Clinically significant bacteremia or fungemia within 7 days prior to
- •Screening that has not been adequately treated, as determined by the
- •investigator
- •10. Clinically significant bacterial, fungal, or viral pneumonia within 2
- •weeks prior to Screening that has not been adequately treated, as
- •determined by the investigator
- •11. Excessive nausea/vomiting at Screening, as determined by the
- •investigator, or an inability to swallow pills that precludes oral
- •administration of the IMP (for subjects without an NG tube in place)
- •12. Any condition which, in the opinion of the investigator, would
- •prevent full participation in this trial or would interfere with the
- •evaluation of the trial endpoints
- •Related to allergies:
- •13. 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)
- •14. History of hypersensitivity, anaphylactic reaction, Stevens-Johnson
- •Syndrome, or toxic epidermal necrolysis response to sulfa drugs
- •Related to laboratory results:
- •15. Creatinine clearance < 30 mL/min (calculated using the Cockcroft-
- •Gault method)
- •16. Clinically significant ALT/AST, as determined by the investigator
- •17. Clinically significant TB, as determined by the investigator
研究者
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