NCT06094010招募中3 期
A Phase IIIb Multicenter, Single-arm, Open-label Surveillance Study of Susceptibility to Baloxavir Marboxil in Pediatric Patients With Influenza and Transmission of Influenza to Household Contacts
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 1,100
- 试验地点
- 87
- 主要终点
- Part A: Percentage of Participants With Resistance-associated Pre-treatment Substitutions
研究概览
简要总结
This study consists of two parts: Part A Surveillance and Part B Transmission.
The main purpose of Part A is to evaluate the prevalence of pre-dose and treatment-emergent amino acid substitutions in pediatric participants' <12 years with influenza treated with baloxavir marboxil.
Part B will include a subset of Part A participants who have household contacts (HHCs) recruited to the study. Part B will evaluate the incidence of onward influenza transmission from pediatric index participants (IPs) under 5 years of age and those aged 5 to under 12 years, treated with baloxavir marboxil, to their HHCs. Participants will no longer be enrolled to Part B Transmission as per protocol version 3.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Weeks 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with symptoms suggestive of influenza based on investigator's judgement with diagnosis confirmed by a positive local influenza test within 24 hours before full study screening
- •Participants with a negative severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) test within 48 hours before full study screening
- •Time interval between onset of influenza symptoms and the start of pre-dose examinations at screening is 48 hours or less
- •Inclusion Criteria (Part B):
- •Eligible to take part in Part A
- •Lives in a household with a HHC willing to be recruited as full HHC
- •[B] HHCs:
- •- Each HHC living in the home of an IP at the time of IP treatment must be screened for partial or full-study HHC eligibility
- •[C] Partial HHC:
- •Starts screening within 1 calendar day after IP treatment
- •Negative influenza and SARS-CoV-2 test at screening after IP's treatment with baloxavir marboxil
- •HHC lives in a household where 1 or more HHCs meet the full-study HHC requirements AND at least 1 full-study HHC has not received the influenza vaccine within 6 months prior to screening
- •HHC lives in a household where 1 or more HHCs meet the full-study HHC requirements, and at least 1 full-study HHC has not received the influenza vaccine within 6 months prior to screening.
- •HHC lives with other HHCs (if applicable) who fulfill all the "partial HHC" criteria
- •[D] Full-study HHC:
- •Fulfills the "partial HHC" criteria
- •Agrees to participate in the full study
- •Will reside in the IP's house for at least 12 of the next 15 days and will be present for scheduled study visits
- •No influenza symptoms within 7 days prior to screening
- •Does not have a moderate or worse active infections or infections requiring systemic or otherwise internally administered or otherwise internally administered antibiotic/antiviral/antifungal therapy
排除标准
- •Participants with severe influenza virus infection requiring inpatient treatment
- •Severely immunocompromised participants (including participants receiving immunosuppressant therapy, or those with cancer or human immunodeficiency virus [HIV] infection) as defined by the investigator
- •Participants with concurrent (non-influenza) infections requiring systemic anti-microbial and/or anti-viral therapy at the pre-dose examinations
- •Treatment with baloxavir marboxil, peramivir, laninamivir, oseltamivir, zanamivir, rimantadine, umifenovir or amantadine within 30 days prior to screening
- •Treatment with an investigational influenza-specific monoclonal antibody within 6 months or 5 half-lives, whichever is longer, prior to screening
- •Treatment with an investigational therapy within 30 days or 5 half-lives, whichever is longer, prior to screening
- •Known hypersensitivity to baloxavir marboxil or the drug product excipients
- •Females who have commenced menarche (i.e., child-bearing potential)
- •Exclusion Criteria (Part B):
- •IPs who fulfil an exclusion criterion for Part A
- •HHCs deemed to require influenza post-exposure prophylaxis with influenza antiviral treatment due to their risk of developing influenza-related complications in accordance with local guidelines or clinical practice
- •HHCs diagnosed with influenza by health care professional in the past 4 weeks
研究组 & 干预措施
Baloxavir Marboxil
Experimental
Participants will receive a single oral dose of baloxavir marboxil on Day 1 (based on body weight and age). HHCs related to IPs will be enrolled but will not receive treatment.
干预措施: Baloxavir Marboxil (Drug)
结局指标
主要结局
Part A: Percentage of Participants With Resistance-associated Pre-treatment Substitutions
时间窗: Day 1 (At Baseline)
Part A: Percentage of Participants With Resistance-associated Pre-treatment Substitutions
时间窗: Day 1 (Baseline)
Part A: Percentage of Participants With Resistance-associated Treatment-emergent Substitutions
时间窗: Days 4, 6 and 10
次要结局
- Part A: Percentage of IPs With Influenza Virus Type (A or B) and Subtype (A/H1 or A/H3)(Day 1 (At Baseline))
- Part A: Change From Baseline in Viral Titers by Quantitative Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)(At Baseline (Day 1); Days 4, 6 and 10)
- Part A: Percentage of IPs With Resistance-associated Treatment-emergent Substitutions by Age Groups (<5 Years [< 1 Year, ≥ 1 Year to < 5 Years], and 5 to < 12 Years)(Days 4, 6 and 10)
- Part A: Percentage of IPs With Novel Treatment-emergent Mutations in Polymerase Acidic Protein (PA)(Days 4, 6 and 10)
- Part A: Percentage of IPs With Resistance-associated Treatment-emergent Substitutions by Baseline Vaccination Status(Days 4, 6 and 10)
- Part A: Percentage of IPs With Influenza Virus Type (A or B) and Subtype (A/H1 or A/H3)(Day 1 (Baseline))
- Part A: Change From Baseline in Viral Titers by Quantitative Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)(Baseline (Day 1); Days 4, 6 and 10)
- Part A: Susceptibility to Baloxavir Marboxil by Phenotyping of Virus With Novel Genotypic PA Substitutions(Days 4, 6 and 10)
- Part A: Number of IPs with Adverse Events (AEs) and Serious Adverse Events (SAEs)(Up to Day 29)
- Part B: Percentage of HHCs With Transmission of Influenza Virus by Confirmed by Central RT-PCR, With Virus Subtype Consistent With the IP(Day 6, Day 10)
- Part B: Percentage of HHCs Who Develops Influenza Symptoms With Transmission of Influenza Virus Confirmed by Central RT-PCR, With Virus Subtype Consistent With the IP(Day 6, Day 10)
研究者
研究点 (87)
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