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Die klinische Studie NCT06775405 für Respiratory Synctial Virus Infections ist offene rekrutierung. In der Kartenansicht des Klinische Studien Radar und den KI-Entdeckungstools finden Sie alle Details. Oder stellen Sie hier Ihre Fragen. | ||
Eine Studie entspricht den Filterkriterien
Kartenansicht
A Study to Confirm the Effectiveness and Safety of AK0529 in Treating RSV Infections in Hospitalized Infants Phase 3 180 Randomisiert Doppelblind Placebo-kontrolliert
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Die klinische Studie NCT06775405 untersucht Behandlung im Zusammenhang mit Respiratory Synctial Virus Infections. Diese interventionsstudie der Phase 3 hat den Status offene rekrutierung und startete am 29. Februar 2024. Es ist geplant, 180 Teilnehmer aufzunehmen. Durchgeführt von Shanghai Ark Biopharmaceutical Co., Ltd. wird der Abschluss für 1. September 2025 erwartet. Die Daten von ClinicalTrials.gov wurden zuletzt am 15. Januar 2025 aktualisiert.
Kurzbeschreibung
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...Mehr anzeigen
Ausführliche Beschreibung
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 ...
Mehr anzeigenOffizieller Titel
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
Erkrankungen
Respiratory Synctial Virus InfectionsWeitere Studien-IDs
- AK0529-2007
NCT-Nummer
Studienbeginn (tatsächlich)
2024-02-29
Zuletzt aktualisiert
2025-01-15
Studienende (vorauss.)
2025-09
Geplante Rekrutierung
180
Studientyp
Interventionsstudie
PHASE
Phase 3
Status
Offene Rekrutierung
Primäres Ziel
Behandlung
Zuteilungsmethode
Randomisiert
Interventionsmodell
Parallel
Verblindung
Doppelt verblindet
Studienarme/Interventionen
| Teilnehmergruppe/Studienarm | Intervention/Behandlung |
|---|---|
ExperimentellActive 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 |
Placebo-VergleichspräparatPlacebo 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. | PLACEBO Active Substance: Placebo, Pharmaceutical Form: Enteric pellets, Route of Administration: Oral |
Hauptergebnismessungen
Nebenergebnismessungen
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
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) |
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
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) |
Teilnahme-Assistent
Eignungskriterien
Zugelassene Altersgruppen
Kind
Mindestalter
1 Month
Zugelassene Geschlechter
Alle
- 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.Zentrale Studienkontakte
Kontakt: Chao Yu, Master, +86 021-50681677, [email protected]
18 Studienstandorte in 1 Ländern
Beijing Children's Hospital, Capital Medical University, Beijing, China
Xin Ni, MD, PhD, Kontakt, +86 010-59612345, [email protected]
Shunying Zhao, MD, PhD, Kontakt
Xin Ni, MD, PhD, Kontakt
Offene Rekrutierung
Beijing Children's Hospital, Capital Medical University, Beijing, China
Xin Ni, Kontakt, +86-010 59612345, [email protected]
Shunying Zhao, Kontakt
Xin Ni, Kontakt
Offene Rekrutierung
First Hospital of Jilin University, Changchun, China
Hongmei Qiao, MD, PhD, Kontakt, +86 0431-88782222, [email protected]
Hongmei Qiao, Kontakt
Offene Rekrutierung
Hunan Provincial People's Hospital, Changsha, China
Lili Zhong, MD, PhD, Kontakt, +86 0731-83929900, [email protected]
Lili Zhong, Kontakt
Offene Rekrutierung
West China Second University Hospital, Sichuan University, Chengdu, China
Hanmin Liu, MD, PhD, Kontakt, +86 028-88570307, [email protected]
Hanmin Liu, Kontakt
Offene Rekrutierung
Children's Hospital, Zhejiang University School of Medicine, Hangzhou, China
Zhimin Chen, MD, PhD, Kontakt, +86 0571-87061007, [email protected]
Zhimin Chen, Kontakt
Offene Rekrutierung
Sanya Central Hospital, Hainan Third People's Hospital, Sanya, China
Hua Zhang, MD, PhD, Kontakt, +86 0898-38220187, [email protected]
Hua Zhang, Kontakt
Offene Rekrutierung
Shanghai Children's Hospital, Shanghai Jiao Tong University, Shanghai, China
Xiaoyan Dong, MD, PhD, Kontakt, +86 021-52976017, [email protected]
Xiaoyan Dong, Kontakt
Offene Rekrutierung
Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China
Yong Yin, MD, PhD, Kontakt, +86 021-38626161, [email protected]
Yong Yin, Kontakt
Offene Rekrutierung
Shengjing Hospital of China Medical University, Shenyang, China
Yunxiao Shang, Kontakt, +86 024 96615, [email protected]
Yunxiao Shang, Kontakt
Offene Rekrutierung
Tianjin Children's Hospital（Longyan）, Tianjin, China
Yongsheng Xu, MD, PhD, Kontakt, +86 022-87787101, [email protected]
Yongsheng Xu, Kontakt
Offene Rekrutierung
Tianjin Children's Hospital（Machang）, Tianjin, China
Yingxue Zou, MD, PhD, Kontakt, +86 022-23519459, [email protected]
Yingxue Zou, Kontakt
Offene Rekrutierung
Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, China
Hailin Zhang, MD, PhD, Kontakt, +86 0577 - 88002682, [email protected]
Hailin Zhang, Kontakt
Offene Rekrutierung
Wuhan Children's Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
Xiaoxia Lu, Kontakt, +86 027-82433350, [email protected]
Xiaoxia Lu, Kontakt
Offene Rekrutierung
Wuxi Children's Hospital, Wuxi, China
Ling Li, MD, PhD, Kontakt, +86 0510-85350188, [email protected]
Ling Li, Kontakt
Offene Rekrutierung
First Affiliated Hospital of Xiamen University, Xiamen, China
Yungang Yang, MD, PhD, Kontakt, +86 0592-2132222, [email protected]
Yungang Yang, Kontakt
Offene Rekrutierung
Women and Children's Hospital, and the School of Medicine, Xiamen University, Xiamen, China
Tong Shen, MD, PhD, Kontakt, +86 0592-2662020, [email protected]
Tong Shen, Kontakt
Offene Rekrutierung
Zhongshan Women and Children's Hospital-Zhongshan Boai Hospital, Zhongshan, China
Dongming Huang, MD, PhD, Kontakt, +86 0760-88306123, [email protected]
Dongming Huang, Kontakt
Offene Rekrutierung