EUCTR2019-001509-25-GB进行中（未招募）1 期
A Two-Part Study With a Birth Cohort (Observational Stage) for Early Diagnosis of Respiratory Syncytial Virus (RSV), Followed by an Optional Phase 2a, Randomized, Double-blind, Placebo-controlled Study (Interventional Stage) to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of JNJ-53718678 in Infants With Acute Respiratory Tract Infection due to RSV
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,300
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
- •Part 1: Observational Stage
- •Each potential participant must satisfy all of the following criteria to be enrolled in the observational stage of the study:
- •1.The infant is =4 months of age at enrollment and asymptomatic for ARI-like symptoms requiring medical intervention at the time of consent to participate in the study.
- •2.Participant’s parent(s) (preferably both if available or as per local requirements) or their legally acceptable representative(s) must sign an ICF (observational stage) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to allow the infant to participate in the study and is willing/able to adhere to the study procedures and assessments to be performed by the parent(s)/caregiver(s) as well as those by the investigator/site staff.
- •3.At least 1 parent/caregiver must be able to use the RSV mobile App at home via his/her own Android/iOS electronic device (compatible with RSV mobile App).
- •4.At least 1 parent/caregiver should be of legal consent age (according to local regulation).
- •Part 2: Interventional Stage
- •Each potential participant must satisfy all of the following criteria to be enrolled in the interventional stage of the study:
- •1.The participant has been diagnosed with RSV infection using a rapid molecular-based diagnostic assay.
- •2.Participant’s parent(s) (preferably both if available or as per local requirements) or their legally acceptable representative(s) has/have signed an ICF (interventional stage) indicating that he or she understands the purpose of, and procedures required for, the interventional stage of the study and is willing to allow the infant to be treated with JNJ 53718678 or placebo and is willing and able to adhere to the prohibitions and restrictions with regards to the concomitant medication (see Section 6.5), the lifestyle consideration (see Section 5.3), and study procedures and assessments to be performed by the parent(s)/caregiver(s) as well as those by the investigator/site staff.
- •Refusal to give consent for the interventional stage does not exclude a participant from continued participation in the observational stage of the study.
- •3.The participant is at least 28 days old at the time of consent.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 1300
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Part 1: Observational Stage
- •Any potential participant who meets any of the following criteria will be excluded from participating in the observational stage of the study:
- •1.Inclusion in (maternal) RSV vaccine studies or RSV treatment studies.
- •2.During the RSV circulation, the infant is experiencing ARI-like symptoms requiring medical intervention on the day of enrollment.
- •3.Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.
- •4.The participant has any physical abnormality which limits the ability to collect regular nasal specimens.
- •5.The participant is receiving chronic home oxygen therapy at enrollment.
- •Part 2: Interventional Stage
- •Any potential participant who meets any of the following criteria will be excluded from participating in the interventional stage of the study:
- •1. The participant has major congenital anomalies or known cytogenetic or metabolic disorders other than the ones allowed below.
- •Note: Isolated open ductus arteriosus and open foramen ovale are not exclusionary as these are not considered major anomalies. Participants with congenital heart disease, cystic fibrosis, congenital diaphragmatic hernia, or Down Syndrome are allowed to participate.
- •2. The participant is considered by the investigator to be immunocompromised, whether due to underlying medical condition (eg, malignancy or genetic disorder other than immunoglobulin A deficiency, or known HIV infection) or medical therapy (eg, immunomodulators other than corticosteroids for the treatment of comorbidities, chemotherapy, radiation, stem cell or solid organ transplant).
- •3. The participant has known or clinically suspected hepatitis B or C infection, either acute or chronic active.
- •4. Criterion modified per Amendment 2.
- •4.1 The participant has other clinically significant abnormal ECG findings not consistent with the present risk factor for severe RSV disease (if applicable) in the study population, as judged by the investigator based on the machine read ECG results at screening.
- •5. Criterion modified per Amendment 2.
- •5.1 The participant has a QTcF interval >450 ms per the machine read (mean of triplicate) parameter result confirmed by repeat triplicate ECG recording during screening.
研究者
相似试验
进行中（未招募）
1 期
A birth cohort study for early diagnosis of RSV followed by an interventional stage to study the antiviral activity, dosing, safety, efficacy, and tolerability of JNJ-53718678 in pediatric participants with RSV.Acute Respiratory Tract Infection due to RSVMedDRA version: 20.1Level: LLTClassification code 10066740Term: Acute respiratory tract infectionSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 21.1Level: PTClassification code 10061603Term: Respiratory syncytial virus infectionSystem Organ Class: 10021881 - Infections and infestationsEUCTR2019-001509-25-BEJanssen Sciences Ireland UC800
尚未招募
不适用
Observational and Cross-Sectional Natural History Study for Farber DiseaseCTRI/2018/03/012336Enzyvant Farber GmbH
已完成
不适用
A comparison of ongoing symptoms and functional impacts of people testing PCR-positive to either COVID-19 or influenza, and people testing PCR-negative to these illnesses.COVID-19Public Health - Health service researchInfection - Studies of infection and infectious agentsRespiratory - Other respiratory disorders / diseasesInfluenzaACTRN12623000041651Queensland Health30,040
招募中
不适用
An observational cohort study on the relationship between lifestyle-related diseases and plasma amino acid concentrations in the subjects undergoing comprehensive health check-up, Ningen Dockifestyle-related diseaseJPRN-UMIN000015679Ajinomoto Co., Inc.12,000
进行中（未招募）
不适用
A two part study to a) investigate the reproducilibility of the vaginal photoplethysmograhpy (VPP) teqnique in healthy pre-menopausal volunteers and subjects suffering from Female Sexual Arousal Disorder (FSAD) and b) a randomised double blind, placebo conrolled 4-way crossover study to investigate the effect of single oral doses (10, 50 and 400 mg)of UK-447,841 on vaginal blood flow in pre-menopausal subjects suffering from FSAD. - N/AFemale Sexual Arousal Disorder (FSAD)Classification code 10062641EUCTR2004-001378-19-SEPfizer AB40