EUCTR2016-001653-40-PL进行中（未招募）1 期
A Phase 2b, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of Orally Administered ALS-008176 Regimens in Adult Subjects Hospitalized with Respiratory Syncytial Virus - A Phase 2b study for adults with Respiratory Syncytial Virus.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 216
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
- •Each potential subject must satisfy all of the following criteria to be enrolled in the study:
- •1. Men or women =18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place), defined at the time of randomization.
- •2. Hospitalized (or in emergency room prior to hospitalization) at the
- •time of randomization and unlikely to be discharged for the first 24
- •hours after randomization.
- •3. Criterion modified per Amendment 2:
- •3.1 Diagnosed with RSV infection based on polymerase chain reaction
- •(PCR)-based assay with or without co-infection with another respiratory
- •pathogen (eg, influenza, human metapneumovirus, or bacteria).
- •4. Criterion modified per Amendment 2:
- •4.1 Has an acute respiratory illness with signs and symptoms consistent
- •with a viral infection (eg, fever, cough, nasal congestion, runny nose,
- •sore throat, myalgia, lethargy, shortness of breath, or wheezing) with
- •onset =5 days from the anticipated time of randomization.
- •5. Criterion modified per Amendment 2:
- •5.1 With the exception of the RSV disease, medically stable on the basis
- •of medical history, physical examination, vital signs, and 12-lead ECG
- •performed at screening. If there are abnormalities, they must be
- •consistent with the underlying illness in the study population and/or
- •RSV infection. This determination must be recorded in the subject's
- •source documents and initialed by the investigator.
- •6. Medically stable on the basis of clinical laboratory tests performed at
- •screening. If the results of the serum chemistry, haematology, or
- •urinalysis are outside the normal reference ranges, the subject may be
- •included only if the investigator judges the abnormalities or deviations
- •from normal do not pose an unacceptable risk to the subject, are not
- •clinically significant, or are appropriate and reasonable for the
- •population under study. This determination must be recorded in the
- •subject's source documents and initialed by the investigator. A single
- •repeat laboratory evaluation is allowed for eligibility determination.
- •7. Must sign an ICF (or their legally acceptable representative must sign)
- •indicating that he or she understands the purpose of, and procedures
- •required for, the study and is willing to participate in the study.
- •8. Criterion modified per Amendment 2:
- •8.1 A woman must have a negative urine ß-human chorionic
- •gonadotropin at screening.
- •9. Criterion modified per Amendment 2:
- •9.1 Contraceptive use by women should be consistent with local
- •regulations regarding the use of contraceptive methods for subjects
- •participating in clinical studies.
- •Before randomization, a woman must be either:
- •a. Not of childbearing potential defined as:
- •Postmenopausal: a postmenopausal state is defined as >45 years and
- •no menses for 12 consecutive months without an alternative medical
- •Permanently sterile: permanent sterilization methods include
- •hysterectomy, bilateral salpingectomy, bilateral tubal occlusion/ligation
- •procedures (without reversal operation), and bilateral oophorectomy.
- •b. Of childbearing potential and, if heterosexually active,
- •Practicing a highly effective method of contraception (failure rate of
- •<1% per year when used consistently and correctly)
- 另有 4 项未显示
排除标准
- •4.2. Exclusion Criteria
- •Any potential subject who meets any of the following criteria will be
- •excluded from participating in the study:
- •1. Subjects who are not expected to survive for more than 48 hours.
- •2. Subjects who have had major thoracic or abdominal surgery in the 6
- •weeks prior to randomization.
- •3. Criterion modified per Amendment 2:
- •3.1 Subjects who are considered by the investigator to be
- •immunocompromised within the past 12 months, whether due to
- •underlying medical condition (e.g., malignancy or genetic disorder) or
- •medical therapy (e.g., medications other than corticosteroids for the
- •treatment of COPD or asthma exacerbations, chemotherapy, radiation,
- •stem cell or solid organ transplant).
- •4. Subjects with a known history of human immunodeficiency virus
- •(HIV) or chronic viral hepatitis.
- •5. Subjects with ALT =3 times the upper limit of normal (ULN) AND
- •bilirubin =2×ULN (direct >35%) OR ALT =5×ULN at screening.
- •6. Criterion modified per Amendment 2:
- •6.1 Subjects undergoing peritoneal dialysis, haemodialysis, or
- •hemofiltration or with an estimated glomerular filtration rate (GFR,
- •determined by Chronic Kidney Disease Epidemiology Collaboration
- •[CKDEPI] equation) of <60 mL/min/1.73m2.
- •7. Known allergies, hypersensitivity, or intolerance to ALS-008176 or its
- •excipients (refer to the IB).
- •8. Criterion deleted per Amendment 2
- •9. Subjects unwilling to undergo mid-turbinate nasal swab procedures or
- •with any physical abnormality which limits the ability to collect regular
- •nasal specimens.
- •10. Subjects unable to take medications enterally or with a known
- •gastrointestinal-related condition that is considered by the sponsor or
- •investigator to be likely to interfere with study drug absorption.
- •11. Women who are pregnant or breastfeeding.
- •12. Criterion modified per Amendment 2:
- •12.1 Men who plan to father a child while enrolled in this study or within
- •104 days after the last dose of study drug.
- •13. Subjects taking any disallowed therapies as noted in Section 8 before
- •the planned first dose of study drug.
- •14. Criterion modified per Amendment 2:
- •14.1 Subjects who received prescription medications intended to prevent
- •or treat the RSV infection itself (eg, ribavirin, IV immunoglobulin,
- •palivizumab), an investigational drug, an investigational vaccine, or used
- •an invasive investigational medical device within 30 days or 5 half-lives
- •(whichever is longer) before the planned first dose of study drug or is
- •currently enrolled in an investigational study.
- •15. Subjects with any condition for which, in the opinion of the
- •investigator, participation would not be in the best interest of the
- •subject (e.g., compromise the well-being) or that could prevent, limit, or
- •confound the protocol-specified assessments.
- •16. Subjects who have used systemic corticosteroids for >7 consecutive
- •days immediately prior to randomization at doses higher than 20
- 另有 9 项未显示
研究者
相似试验
进行中（未招募）
1 期
A controlled clinical trial to study RM-131 (relamorelin) in patients with vomiting symptoms and diabetic gastroparesisEUCTR2014-005623-27-GBMotus Therapeutics, Inc.393
进行中（未招募）
1 期
A Phase 2b study for adults hospitalized with Respiratory Syncytial Virus.Respiratory Syncytial Virus InfectionEUCTR2016-001653-40-NLJanssen-Cilag International NV49
进行中（未招募）
1 期
A Phase 2b study for adults hospitalized with Respiratory Syncytial Virus.Respiratory Syncytial Virus InfectionEUCTR2016-001653-40-BGJanssen-Cilag International NV49
进行中（未招募）
1 期
A study to investigate the effects of lumicitabine (JNJ-64041575) in hospitalized adults infected with human metapneumovirusHuman metapneumovirus infectionMedDRA version: 20.0Level: PTClassification code 10066226Term: Metapneumovirus infectionSystem Organ Class: 10021881 - Infections and infestationsEUCTR2017-001696-22-ESJanssen-Cilag International NV180
进行中（未招募）
1 期
A study to investigate the effects of lumicitabine (JNJ-64041575) in hospitalized adults infected with human metapneumovirusHuman metapneumovirus infectionMedDRA version: 20.0Level: PTClassification code 10066226Term: Metapneumovirus infectionSystem Organ Class: 10021881 - Infections and infestationsEUCTR2017-001696-22-SEJanssen-Cilag International NV180