임상 레이더 AI | ||
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임상시험 NCT06775405은(는) Respiratory Synctial Virus Infections에 대해 모집중 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
하나의 임상시험이 필터 기준과 일치합니다.
카드 뷰
A Study to Confirm the Effectiveness and Safety of AK0529 in Treating RSV Infections in Hospitalized Infants 3상 180 무작위 배정 이중 눈가림 위약 대조
임상시험 세부 정보는 주로 영어로 제공됩니다. 하지만 임상 레이더 AI가 도와드릴 수 있습니다! '임상시험 설명'를 클릭하여 선택한 언어로 임상시험 정보를 확인하고, 이에 대해 AI와 논의해 보세요.
임상시험 NCT06775405은(는) 치료을(를) 알아보기 위한 연구입니다. 이 연구는 Respiratory Synctial Virus Infections에 대해 진행되며, 3상 중재연구으로 현재 상태는 모집중입니다. 연구는 2024년 2월 29일에 시작되어 180명의 참여자를 모집하고 있습니다. Shanghai Ark Biopharmaceutical Co., Ltd.이(가) 진행하며, 2025년 9월 1일까지 완료될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2025년 1월 15일에 갱신되었습니다.
간단한 개요
Respiratory syncytial virus (RSV) is the most common respiratory infectious pathogen recognized worldwide that poses serious health risks to infants, and an important cause of hospitalization for severe respiratory infections in infants. Serious respiratory problems such as pneumonia caused by RSV are one of the leading causes of death from respiratory diseases in infants. AK0529 targets the Pre-F (fusion) protein on...더 보기
상세한 설명
This is a Phase III, randomized, double-blind, placebo-controlled, multicenter clinical study conducted among Chinese infants aged 1 to 24 months hospitalized with Respiratory Syncytial Virus (RSV) infection.
The study plans to enroll 180 infants aged 1 to 24 months with RSV infection. Eligible subjects will be randomized in a 1:1 ratio (AK0529: placebo). These subjects will receive the study drug twice daily for 5 ...
더 보기공식 제목
A Randomized, Double-blind, Placebo-controlled, Phase III Confirmatory Study to Evaluate the Efficacy, Safety, Tolerability, and Antiviral Activity of Repeated Oral Administration of AK0529 in Hospitalized Infants with Respiratory Syncytial Virus Infection
질환명
Respiratory Synctial Virus Infections기타 연구 식별자
- AK0529-2007
NCT 번호
실제 연구 시작일
2024-02-29
최신 업데이트 게시
2025-01-15
예상 연구 완료일
2025-09
계획된 등록 인원
180
연구종류
중재연구
단계/상
3상
상태
모집중
주요 목적
치료
설계 할당
무작위배정
중재 모델
평행설계
맹검 (마스킹)
이중맹검
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
실험적Active drug The participants will receive AK0529 of 10 mg, 20 mg or 40 mg based on body weight twice daily for 5 days from D1 to D5. | AK0529 Active Substance: AK0529, Pharmaceutical Form: Enteric pellets, Route of Administration: Oral |
위약 대조군Placebo The participants will receive placebo of 10 mg, 20 mg or 40 mg based on body weight twice daily for 5 days from D1 to D5. | 위약 Active Substance: Placebo, Pharmaceutical Form: Enteric pellets, Route of Administration: Oral |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Change from baseline in the Wang bronchiolitis clinical score | The Wang bronchiolitis clinical score will be used to evaluate respiratory rate, wheezing, respiratory muscle retraction and "general condition" (sleep, feeding, and general status) in subjects with symptoms of bronchiolitis. Each item of the scale is divided into 4 levels according to the severity of symptoms, with 0 point indicating normal and 3 points the highest severity, 12 points in total. | Day 3 (48 hours) |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Change from baseline in the Wang bronchiolitis clinical score in subjects younger than 6 months. | The Wang bronchiolitis clinical score will be used to evaluate respiratory rate, wheezing, respiratory muscle retraction and "general condition" (sleep, feeding, and general status) in subjects with symptoms of bronchiolitis. Each item of the scale is divided into 4 levels according to the severity of symptoms, with 0 point indicating normal and 3 points the highest severity, 12 points in total. | Day 3 (48 hours) |
Time from first treatment to sustained remission of symptoms during the treatment period. | The sustained remission is defined as achieving a total Wang bronchiolitis clinical score of 0 or 1 for 48 consecutive hours without support of oxygen therapy. | Study period (up to 14 days) |
Change in RSV VL (viral load) from baseline at each visit. | The viral load of subjects' nasopharyngeal samples will be measured by quantitative reverse transcription polymerase chain reaction (qRT-PCR). | Day 2, Day 3, Day 4, Day 5, Day 6, Day 14 |
Proportion of subjects with RSV VL below the lower limit of quantitation (LLOQ) at each visit. | The viral load of subjects' nasopharyngeal samples will be measured by quantitative reverse transcription polymerase chain reaction (qRT-PCR). | Day 2, Day 3, Day 4, Day 5, Day 6, Day 14 |
Time from first treatment to mild disease for subjects, defined as achieving a Wang bronchiolitis clinical score ≤ 3 without the need for supplemental oxygen. | Study period (up to 14 days) | |
Change in sub-scores of the Wang bronchiolitis clinical score from baseline at each visit. | The Wang bronchiolitis clinical score will be used to evaluate respiratory rate, wheezing, respiratory muscle retraction and "general condition" (sleep, feeding, and general status) in subjects with symptoms of bronchiolitis. Each item of the scale is divided into 4 levels according to the severity of symptoms, with 0 point indicating normal and 3 points the highest severity, 12 points in total. | Day 2, Day 3, Day 4, Day 5, Day 6, Day 14 |
Time from initial dosing to resolution of symptoms based on sub-scores of the Wang bronchiolitis clinical score. | The resolution is defined as achieving the following sub-scores without the need for supplemental oxygen:
* Respiratory rate = 0 or 1
* Wheezing = 0 or 1
* Respiratory muscle retraction = 0 or 1
* General condition = 0 Note: The above indicators are only for subjects with a baseline sub-score greater than 0 for the respective sub-scores. | Study period (up to 14 days) |
Safety endpoints | The safety assessment includes the following events, tests, indicators occurring during the study process:
* Incidence rate and severity of Adverse Events (AEs), Serious Adverse Events (SAEs), and withdrawal from the study due to AEs;
* Laboratory tests;
* Electrocardiogram (ECG);
* Physical examination and vital signs. | Study period (up to 14 days) |
Pharmacokinetic endpoints | Include but not limit to steady state AUC, Cmax and Ctrough. | Study period (up to 14 days) |
참여 도우미
적격성 기준
연령대
어린이
최소 연령
1 Month
참여 가능한 성별
전체
- Male or female subjects of any ethnicity with an age adjusted for any prematurity of ≥1 month and ≤24 months.
- Diagnosis of RSV infection by any virological means, including a rapid diagnostic point-of-care testing, within 36 hours preceding initial dosing.
- The onset of RSV infection symptoms should be ≤ 5 days prior to initial dosing.
- Subject must weigh ≥ 2.5 kg and ≤ 20 kg at screening and be within the normal range for the subject's age, based on local child growth standards.
- Subject must have a Wang bronchiolitis clinical score ≥ 5.
- The subject has taken any restricted medications within 3 days prior to the date of screening or requires any restricted medications during treatment phase (including interferons, ribavirin, or proprietary Chinese medicines with antiviral effects) and has taken any inhaled or systemic glucocorticoids within 24 hours.
- Subject is known to have co-infection with influenza virus, Mycoplasma, or other respiratory tract pathogens that require targeted clinical treatment .
- Subject is known to have bacterial pneumonia.
- Subject with clinical evidence of hepatic decompensation (e.g., liver disease with coagulation abnormalities or encephalopathy).
- Subject with inborn symptoms of metabolic abnormalities (e.g., mitochondrial diseases, carbohydrate metabolism abnormalities, glycogen accumulation diseases).
- Subject with chronic or persistent feeding difficulties.
- The parent or guardian of the subject is an employee of the study investigator or the study facility (such person will be directly involved in the study or any other study administered by the study facility investigator), or a family member of the study investigator or his/her staff.
- Subject who have participated in clinical trials of other drugs or devices in the 30 days prior to screening.
- Subject with any other reason that the investigator deems unsuitable for participation in the study.
Shanghai Ark Biopharmaceutical Co., Ltd.연구 대표 연락처
연락처: Chao Yu, Master, +86 021-50681677, [email protected]
18 1개국에 임상시험 장소
Beijing Children's Hospital, Capital Medical University, Beijing, China
Xin Ni, MD, PhD, 연락처, +86 010-59612345, [email protected]
Shunying Zhao, MD, PhD, 연락처
Xin Ni, MD, PhD, 연락처
모집중
Beijing Children's Hospital, Capital Medical University, Beijing, China
Xin Ni, 연락처, +86-010 59612345, [email protected]
Shunying Zhao, 연락처
Xin Ni, 연락처
모집중
First Hospital of Jilin University, Changchun, China
Hongmei Qiao, MD, PhD, 연락처, +86 0431-88782222, [email protected]
Hongmei Qiao, 연락처
모집중
Hunan Provincial People's Hospital, Changsha, China
Lili Zhong, MD, PhD, 연락처, +86 0731-83929900, [email protected]
Lili Zhong, 연락처
모집중
West China Second University Hospital, Sichuan University, Chengdu, China
Hanmin Liu, MD, PhD, 연락처, +86 028-88570307, [email protected]
Hanmin Liu, 연락처
모집중
Children's Hospital, Zhejiang University School of Medicine, Hangzhou, China
Zhimin Chen, MD, PhD, 연락처, +86 0571-87061007, [email protected]
Zhimin Chen, 연락처
모집중
Sanya Central Hospital, Hainan Third People's Hospital, Sanya, China
Hua Zhang, MD, PhD, 연락처, +86 0898-38220187, [email protected]
Hua Zhang, 연락처
모집중
Shanghai Children's Hospital, Shanghai Jiao Tong University, Shanghai, China
Xiaoyan Dong, MD, PhD, 연락처, +86 021-52976017, [email protected]
Xiaoyan Dong, 연락처
모집중
Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China
Yong Yin, MD, PhD, 연락처, +86 021-38626161, [email protected]
Yong Yin, 연락처
모집중
Shengjing Hospital of China Medical University, Shenyang, China
Yunxiao Shang, 연락처, +86 024 96615, [email protected]
Yunxiao Shang, 연락처
모집중
Tianjin Children's Hospital（Longyan）, Tianjin, China
Yongsheng Xu, MD, PhD, 연락처, +86 022-87787101, [email protected]
Yongsheng Xu, 연락처
모집중
Tianjin Children's Hospital（Machang）, Tianjin, China
Yingxue Zou, MD, PhD, 연락처, +86 022-23519459, [email protected]
Yingxue Zou, 연락처
모집중
Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, China
Hailin Zhang, MD, PhD, 연락처, +86 0577 - 88002682, [email protected]
Hailin Zhang, 연락처
모집중
Wuhan Children's Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
Xiaoxia Lu, 연락처, +86 027-82433350, [email protected]
Xiaoxia Lu, 연락처
모집중
Wuxi Children's Hospital, Wuxi, China
Ling Li, MD, PhD, 연락처, +86 0510-85350188, [email protected]
Ling Li, 연락처
모집중
First Affiliated Hospital of Xiamen University, Xiamen, China
Yungang Yang, MD, PhD, 연락처, +86 0592-2132222, [email protected]
Yungang Yang, 연락처
모집중
Women and Children's Hospital, and the School of Medicine, Xiamen University, Xiamen, China
Tong Shen, MD, PhD, 연락처, +86 0592-2662020, [email protected]
Tong Shen, 연락처
모집중
Zhongshan Women and Children's Hospital-Zhongshan Boai Hospital, Zhongshan, China
Dongming Huang, MD, PhD, 연락처, +86 0760-88306123, [email protected]
Dongming Huang, 연락처
모집중