ट्रायल रडार AI | ||
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क्लिनिकल ट्रायल NCT06775405 के लिए Respiratory Synctial Virus Infections वर्तमान में भर्ती जारी है। सभी विवरणों के लिए क्लिनिकल ट्रायल रडार कार्ड दृश्य और AI खोज उपकरण देखें, या यहाँ कुछ भी पूछें। | ||
एक परीक्षण फ़िल्टर मानदंडों से मेल खाता है
कार्ड दृश्य
A Study to Confirm the Effectiveness and Safety of AK0529 in Treating RSV Infections in Hospitalized Infants चरण III 180 रैंडमाइज़्ड डबल-ब्लाइंड प्लेसबो-नियंत्रित
चिकित्सा परीक्षण का विवरण मुख्य रूप से अंग्रेजी में उपलब्ध है। हालाँकि, ट्रायल रडार AI मदद कर सकता है! बस 'अध्ययन समझाएं' पर क्लिक करें और अपनी चुनी हुई भाषा में परीक्षण की जानकारी देखें और चर्चा करें।
क्लिनिकल ट्रायल NCT06775405 का मुख्य उद्देश्य उपचार का अध्ययन करना है। यह चिकित्सकीय अध्ययन Respiratory Synctial Virus Infections से जुड़ा हुआ है और यह एक चरण III हस्तक्रियात्मक परीक्षण है। परीक्षण वर्तमान में भर्ती जारी चल रहा है। इसकी शुरुआत 29 फ़रवरी 2024 को हुई थी, और इसमें कुल 180 प्रतिभागियों के नामांकन की योजना है। Shanghai Ark Biopharmaceutical Co., Ltd. इस परीक्षण का नेतृत्व कर रहे हैं और इसके 1 सितंबर 2025 तक पूरा होने की उम्मीद है। ClinicalTrials.gov वेबसाइट पर यह जानकारी 15 जनवरी 2025 को अंतिम बार अपडेट की गई थी।
संक्षिप्त सारांश
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...और दिखाएँ
विस्तृत विवरण
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 ...
और दिखाएँआधिकारिक शीर्षक
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
स्वास्थ्य स्थितियां
Respiratory Synctial Virus Infectionsअन्य अध्ययन आईडी
- AK0529-2007
NCT नंबर
अध्ययन प्रारंभ तिथि (वास्तविक)
2024-02-29
अंतिम अद्यतन प्रकाशित
2025-01-15
अध्ययन की समाप्ति तिथि (अनुमानित)
2025-09
नामांकन (अनुमानित)
180
अध्ययन प्रकार
हस्तक्रियात्मक
चरण
चरण III
स्थिति
भर्ती जारी
प्राथमिक उद्देश्य
उपचार
डिज़ाइन आवंटन
यादृच्छिक
हस्तक्षेप मॉडल
समानांतर
अंधकरण
दोहरा अंध
समूह/हस्तक्षेप
| प्रतिभागी समूह/शाखा | हस्तक्षेप/उपचार |
|---|---|
प्रयोगात्मकActive 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 |
प्लेसबो तुलना समूहPlacebo 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. | प्लेसबो Active Substance: Placebo, Pharmaceutical Form: Enteric pellets, Route of Administration: Oral |
प्राथमिक परिणाम माप
द्वितीयक परिणाम माप
| परिणाम माप | माप विवरण | समय सीमा |
|---|---|---|
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) |
| परिणाम माप | माप विवरण | समय सीमा |
|---|---|---|
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) |
भागीदारी सहायक
पात्रता मानदंड
अध्ययन के लिए पात्र आयु
बच्चा
अध्ययन के लिए न्यूनतम आयु
1 Month
अध्ययन के लिए पात्र लिंग
सभी
- 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.अध्ययन केंद्रीय संपर्क
संपर्क: Chao Yu, Master, +86 021-50681677, [email protected]
18 1 देशों में अध्ययन स्थान
Beijing Children's Hospital, Capital Medical University, Beijing, China
Xin Ni, MD, PhD, संपर्क, +86 010-59612345, [email protected]
Shunying Zhao, MD, PhD, संपर्क
Xin Ni, MD, PhD, संपर्क
भर्ती जारी
Beijing Children's Hospital, Capital Medical University, Beijing, China
Xin Ni, संपर्क, +86-010 59612345, [email protected]
Shunying Zhao, संपर्क
Xin Ni, संपर्क
भर्ती जारी
First Hospital of Jilin University, Changchun, China
Hongmei Qiao, MD, PhD, संपर्क, +86 0431-88782222, [email protected]
Hongmei Qiao, संपर्क
भर्ती जारी
Hunan Provincial People's Hospital, Changsha, China
Lili Zhong, MD, PhD, संपर्क, +86 0731-83929900, [email protected]
Lili Zhong, संपर्क
भर्ती जारी
West China Second University Hospital, Sichuan University, Chengdu, China
Hanmin Liu, MD, PhD, संपर्क, +86 028-88570307, [email protected]
Hanmin Liu, संपर्क
भर्ती जारी
Children's Hospital, Zhejiang University School of Medicine, Hangzhou, China
Zhimin Chen, MD, PhD, संपर्क, +86 0571-87061007, [email protected]
Zhimin Chen, संपर्क
भर्ती जारी
Sanya Central Hospital, Hainan Third People's Hospital, Sanya, China
Hua Zhang, MD, PhD, संपर्क, +86 0898-38220187, [email protected]
Hua Zhang, संपर्क
भर्ती जारी
Shanghai Children's Hospital, Shanghai Jiao Tong University, Shanghai, China
Xiaoyan Dong, MD, PhD, संपर्क, +86 021-52976017, [email protected]
Xiaoyan Dong, संपर्क
भर्ती जारी
Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China
Yong Yin, MD, PhD, संपर्क, +86 021-38626161, [email protected]
Yong Yin, संपर्क
भर्ती जारी
Shengjing Hospital of China Medical University, Shenyang, China
Yunxiao Shang, संपर्क, +86 024 96615, [email protected]
Yunxiao Shang, संपर्क
भर्ती जारी
Tianjin Children's Hospital（Longyan）, Tianjin, China
Yongsheng Xu, MD, PhD, संपर्क, +86 022-87787101, [email protected]
Yongsheng Xu, संपर्क
भर्ती जारी
Tianjin Children's Hospital（Machang）, Tianjin, China
Yingxue Zou, MD, PhD, संपर्क, +86 022-23519459, [email protected]
Yingxue Zou, संपर्क
भर्ती जारी
Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, China
Hailin Zhang, MD, PhD, संपर्क, +86 0577 - 88002682, [email protected]
Hailin Zhang, संपर्क
भर्ती जारी
Wuhan Children's Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
Xiaoxia Lu, संपर्क, +86 027-82433350, [email protected]
Xiaoxia Lu, संपर्क
भर्ती जारी
Wuxi Children's Hospital, Wuxi, China
Ling Li, MD, PhD, संपर्क, +86 0510-85350188, [email protected]
Ling Li, संपर्क
भर्ती जारी
First Affiliated Hospital of Xiamen University, Xiamen, China
Yungang Yang, MD, PhD, संपर्क, +86 0592-2132222, [email protected]
Yungang Yang, संपर्क
भर्ती जारी
Women and Children's Hospital, and the School of Medicine, Xiamen University, Xiamen, China
Tong Shen, MD, PhD, संपर्क, +86 0592-2662020, [email protected]
Tong Shen, संपर्क
भर्ती जारी
Zhongshan Women and Children's Hospital-Zhongshan Boai Hospital, Zhongshan, China
Dongming Huang, MD, PhD, संपर्क, +86 0760-88306123, [email protected]
Dongming Huang, संपर्क
भर्ती जारी