A Study of AK0529 in Chinese Infants Hospitalized With RSV
NCT ID: NCT04231968
Last Updated: 2024-02-13
Study Results
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Basic Information
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COMPLETED
PHASE3
311 participants
INTERVENTIONAL
2020-09-22
2022-02-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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AK0529
Participants who are randomized to the experimental arm will receive AK0529 twice daily for five days .
AK0529
AK0529 capsule will be orally administered at the twice-daily dosing levels of 10 mg, 20 mg, or 40 mg for five days based on the patient's weight.
Placebo
Participants in the control arm will be administered placebo at the matching dosage levels of active medications.
Matching placebo of AK0529
The placebo capsule was made with the same smell and appearance as AK0529 but without the active ingredients and will be orally administered per the same treatment schedule as those in the experimental arm.
Interventions
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AK0529
AK0529 capsule will be orally administered at the twice-daily dosing levels of 10 mg, 20 mg, or 40 mg for five days based on the patient's weight.
Matching placebo of AK0529
The placebo capsule was made with the same smell and appearance as AK0529 but without the active ingredients and will be orally administered per the same treatment schedule as those in the experimental arm.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of RSV infection by any virological means within 36 hours preceding the initial dose.
* The time from the onset caused by RSV infection to the first dose should be ≤ 7 days. Time of onset is defined as the time the first respiratory or systemic signs or symptoms of RSV infection confirmed by the investigator.
* Body weight ≥ 2.5 kg and ≤ 20 kg at screening.
* For patients aged \<12 months, an occipitofrontal head circumference should be within the normal range for age and gender.
* Bronchiolitis score ≥ 5.
* The parent/legal guardian must have provided written informed consent for the patient to participate.
Exclusion Criteria
* Patients (or mothers of patients younger than 6 months of age) with a known HIV-positive history or patients highly suspected HIV-positive by the investigator.
* Patients with known co-infection with influenza virus.
* Patient known to have pneumonia caused by bacterial infection.
* Patients requiring vasopressors or vasoactive drugs at the time of enrollment.
* Concurrent gastrointestinal conditions that could seriously, in the opinion of the investigator, prejudice absorption of the Investigational Medicinal Product.
* Bronchopulmonary dysplasia requiring assisted ventilation at the time of enrolment, except for the result of RSV infection.
* Patients at risk for hypercapnia based on their medical history, except for the result of RSV infection.
* Patient with airway malformations and congenital heart diseases, except for isolated patent ductus arteriosus and/or patent foramen ovale.
* Renal failure including renal abnormalities likely to be associated with renal insufficiency.
* Clinical evidence of hepatic decompensation.
* Symptomatic because of congenital metabolic abnormality.
* Chronic or persistent feeding difficulties.
* Known or suspected to have primary immunodeficiency disease.
* Any active or uncontrolled respiratory, cardiac, hepatic, central nervous system or renal disease unrelated to RSV infection at baseline, or any other medical condition that in the opinion of the investigator renders the patient unsuitable for enrolment; in case of any question, discuss such cases with the sponsor's medical monitor.
* A history of epilepsy or seizures including febrile seizures.
* History of family history of high allergies or allergies to multiple substances, or presence of severe rash that in the opinion or the investigator renders the patient unsuitable for enrollment.
* The patient's parent or guardian is an employee of the investigator or the study site with direct involvement in the proposed study or other studies under the direction of that investigator of the study site, or any family members of the employees or the investigator.
* Participation in an investigational drug or device study within 30 days prior to the date of screening.
* Failure to satisfy the investigator of fitness to participate for any other reason.
1 Month
24 Months
ALL
No
Sponsors
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Shanghai Ark Biopharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Locations
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Beijing Children's Hospital
Beijing, , China
Peking University Third Hospital
Beijing, , China
The First Bethune Hospital of Jilin University
Changchun, , China
Hunan Provincial People's Hospital
Changsha, , China
West China Women's and Children's Hospital
Chengdu, , China
Children's Hospital of Chongqing Medical University
Chongqing, , China
Guangzhou Women and Children's Medical Center
Guangzhou, , China
The Children's Hospital of Zhejiang University School of Medicine
Hangzhou, , China
Liaocheng People's Hospital
Liaocheng, , China
Jiangxi Provincial Children's Hospital
Nanchang, , China
Children's Hospital of Nanjing Medical University
Nanjing, , China
Jiangsu Province Hospital
Nanjing, , China
The First Affiliated Hospital of Guangxi Medical University
Nanjing, , China
Hainan Third People's Hospital
Sanya, , China
Children's Hospital of Shanghai
Shanghai, , China
Shanghai Children's Medical Center
Shanghai, , China
Shengjing Hospital of China Medical University
Shengyang, , China
Shenzhen Children's Hospital
Shenzhen, , China
Children's Hospital of Soochow University
Suzhou, , China
Tianjin Children's Hospital
Tianjin, , China
The Second Affiliated Hospital and Yuying Children's Hospital of WMU
Wenzhou, , China
Wuhan Children's Hospital
Wuhan, , China
Wuxi Children's Hospital
Wuxi, , China
The First Affiliated Hospital of Xiamen University
Xiamen, , China
Xiamen Maternity and Child Healthcare Hospital
Xiamen, , China
Henan Children's Hospital
Zhengzhou, , China
The Third Affiliated Hospital of Zhengzhou University
Zhengzhou, , China
Boai Hospital of Zhongshan
Zhongshan, , China
Countries
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References
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Zhang H, Zhao W, Zhang X, Zhang L, Guo R, Huang H, Lin L, Liu F, Chen H, Shen F, Wu J, Huang X, Zhu X, Li F, Zou G, Chien J, Humphries M, Lu Q, Wu JZ, Zhao S, Liu H, Ni X; AIRFLO Study Group. Efficacy and safety of ziresovir in hospitalised infants aged 6 months or younger with respiratory syncytial virus infection in China: findings from a phase 3 randomised trial with 24-month follow-up. Lancet Child Adolesc Health. 2025 May;9(5):325-336. doi: 10.1016/S2352-4642(25)00067-7.
Zhao S, Shang Y, Yin Y, Zou Y, Xu Y, Zhong L, Zhang H, Zhang H, Zhao D, Shen T, Huang D, Chen Q, Yang Q, Yang Y, Dong X, Li L, Chen Z, Liu E, Deng L, Jiang W, Cheng H, Nong G, Wang X, Chen Y, Ding R, Zhou W, Zheng Y, Shen Z, Lu X, Hao C, Zhu X, Jia T, Wu Y, Zou G, Rito K, Wu JZ, Liu H, Ni X; AIRFLO Study Group. Ziresovir in Hospitalized Infants with Respiratory Syncytial Virus Infection. N Engl J Med. 2024 Sep 26;391(12):1096-1107. doi: 10.1056/NEJMoa2313551.
Other Identifiers
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AK0529-2003
Identifier Type: -
Identifier Source: org_study_id
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