ट्रायल रडार AI | ||
|---|---|---|
क्लिनिकल ट्रायल NCT07058077 के लिए हेटेरोज़ाइगस पारिवारिक हाइपरकोलेस्टेरोलेमिया (HeFH) 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
खोज पर वापस जाएँ
मर्कA Study of Enlicitide Decanoate (MK-0616, an Oral PCSK9 Inhibitor) in Children and Adolescents With Heterozygous Familial Hypercholesterolemia (MK-0616-029) चरण II, चरण III 153 किशोरावस्था
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 NCT07058077 का मुख्य उद्देश्य उपचार का अध्ययन करना है। यह चिकित्सकीय अध्ययन हेटेरोज़ाइगस पारिवारिक हाइपरकोलेस्टेरोलेमिया (HeFH) से जुड़ा हुआ है और यह एक चरण II चरण III हस्तक्रियात्मक परीक्षण है। परीक्षण वर्तमान में भर्ती जारी चल रहा है। इसकी शुरुआत 21 अगस्त 2025 को हुई थी, और इसमें कुल 153 प्रतिभागियों के नामांकन की योजना है। मर्क इस परीक्षण का नेतृत्व कर रहे हैं और इसके 23 जनवरी 2037 तक पूरा होने की उम्मीद है। ClinicalTrials.gov वेबसाइट पर यह जानकारी 13 मार्च 2026 को अंतिम बार अपडेट की गई थी।
संक्षिप्त सारांश
This study is designed to learn if enlicitide decanoate is safe and effective to treat children and adolescents with heterozygous familial hypercholesterolemia (HeFH) and high amounts of low-density lipoprotein cholesterol (LDL-C) in the blood.
The goals of this study are to learn about the safety of enlicitide and if children tolerate it, what happens to enlicitide in a child's body over time, and if enlicitide wor...
और दिखाएँआधिकारिक शीर्षक
An Operationally Seamless Phase 2/3 Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Enlicitide Decanoate in Pediatric Participants With Heterozygous Familial Hypercholesterolemia
स्वास्थ्य स्थितियां
हेटेरोज़ाइगस पारिवारिक हाइपरकोलेस्टेरोलेमिया (HeFH)अन्य अध्ययन आईडी
- 0616-029
- U1111-1314-5796 (रजिस्ट्री पहचानकर्ता) (UTN)
- 2024-519068-42-00 (रजिस्ट्री पहचानकर्ता) (EU CT)
NCT नंबर
अध्ययन प्रारंभ तिथि (वास्तविक)
2025-08-21
अंतिम अद्यतन प्रकाशित
2026-03-13
अध्ययन की समाप्ति तिथि (अनुमानित)
2037-01-23
नामांकन (अनुमानित)
153
अध्ययन प्रकार
हस्तक्रियात्मक
चरण
चरण II
चरण III
चरण III
स्थिति
भर्ती जारी
प्राथमिक उद्देश्य
उपचार
डिज़ाइन आवंटन
यादृच्छिक
हस्तक्षेप मॉडल
समानांतर
अंधकरण
चौहरा अंध
समूह/हस्तक्षेप
| प्रतिभागी समूह/शाखा | हस्तक्षेप/उपचार |
|---|---|
प्रयोगात्मकPart A: Enlicitide Decanoate Participants receive enlicitide decanoate orally once daily (QD) at a dosage determined by age for up to 2 weeks. | Enlicitide Decanoate Enlicitide decanoate taken by mouth |
प्रयोगात्मकPart B: Enlicitide Decanoate Participants receive enlicitide decanoate QD at a dosage determined by age for up to 24 weeks. | Enlicitide Decanoate Enlicitide decanoate taken by mouth |
प्लेसबो तुलना समूहPart B: Placebo Participants receive placebo orally QD for up to 24 weeks. | प्लेसबो Placebo tablet matched to enlicitide decanoate taken by mouth |
प्रयोगात्मकOpen-Label Extension: Enlicitide Decanoate Participants who complete either Part A or Part B may enroll in this open-label extension arm. Participants in the extension arm receive enlicitide decanoate QD at a dosage determined by age for up to 3 years. | Enlicitide Decanoate Enlicitide decanoate taken by mouth |
प्राथमिक परिणाम माप
द्वितीयक परिणाम माप
| परिणाम माप | माप विवरण | समय सीमा |
|---|---|---|
Part A: Maximum Plasma Concentration (Cmax) of Enlicitide | Blood samples will be collected to determine the Cmax of enlicitide. | At designated timepoints (up to 24 hours postdose on day 14) |
Part A: Area Under the Concentration-Time Curve from 0 to 24 Hours (AUC0-24) of Enlicitide | Blood samples will be collected to determine the AUC0-24 of enlicitide. | At designated timepoints (up to 24 hours postdose on day 14) |
Part B: Percent Change from Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) | Blood samples will be collected to determine the percent change from baseline in LDL-C. | Baseline and Week 24 |
Number of Participants Who Experience an Adverse Event (AE) | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. | Up to approximately 188 weeks |
Number of Participants Who Discontinue Study Treatment Due to an AE | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. | Up to approximately 180 weeks |
| परिणाम माप | माप विवरण | समय सीमा |
|---|---|---|
Part B: Percent Change from Baseline in Apolipoprotein B (ApoB) | Blood samples will be collected to determine the percent change from baseline in apolipoprotein B. | Baseline and week 24 |
Part B: Percent Change from Baseline in Non-High-Density Lipoprotein Cholesterol (non-HDL-C) | Blood samples will be collected to determine the percent change from baseline in non-HDL-C. | Baseline and week 24 |
Part B: Percent Change from Baseline in Lipoprotein (a) (Lp(a)) | Blood samples will be collected to determine the percent change from baseline in Lp(a). | Baseline and week 24 |
Part B: Percentage of Participants With LDL-C <130 mg/dL at Week 24 | The percentage of participants with LDL-C \<130 mg/dL at week 24 will be reported. | Week 24 |
Part B: Percentage of Participants With ≥50% LDL-C LDL-C Reduction from Baseline at Week 24 | The percentage of participants with ≥50% LDL-C reduction from baseline at week 24 will be reported. | Baseline and week 24 |
Part B: Percentage of Participants With LDL-C <100 mg/dL at Week 24 | The percentage of participants with LDL-C \<100 mg/dL at week 24 will be reported. | Week 24 |
Change in Carotid Intima-media Thickness (cIMT) | Ultrasound measurements will be performed to determine the change from baseline in cIMT. | Baseline and week 24 |
भागीदारी सहायक
पात्रता मानदंड
अध्ययन के लिए पात्र आयु
बच्चा
अध्ययन के लिए न्यूनतम आयु
6 Years
अध्ययन के लिए पात्र लिंग
सभी
Inclusion criteria include, but are not limited to:
- Has possible or definite diagnosis of HeFH based on a locally accepted diagnostic algorithm or diagnosis by genetic testing results
- Has a fasted LDL-C value (evaluated by the central laboratory) that is ≥130 mg/dL
- Is receiving either an optimized daily dose of statin (± nonstatin LLT); or a nonstatin LLT with documented intolerance to at least 2 different statins or refusal of statin therapy by the participant or legally acceptable representative
- Is on a stable dose of all background LLTs for at least 30 days prior to screening, with no medication or dose changes planned during participation in Part A or Part B
Exclusion criteria include, but are not limited to:
- Has a history of homozygous FH based on genetic or clinical criteria, or history of known compound heterozygous FH, or double heterozygous FH
- Has a history of nephrotic syndrome
- Has any clinically significant malabsorption condition based on principal investigator assessment
- Was previously treated/is being treated with certain other cholesterol lowering medications, including proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors without adequate washout
मर्कअध्ययन केंद्रीय संपर्क
संपर्क: Toll Free Number, 1-888-577-8839, [email protected]
21 12 देशों में अध्ययन स्थान
Delaware
Nemours/Alfred I. duPont Hospital for Children ( Site 0001), Wilmington, Delaware, 19803, United States
Study Coordinator, संपर्क, 302-651-6600
भर्ती जारी
District of Columbia
Children's National Medical Center ( Site 0015), Washington D.C., District of Columbia, 20010, United States
Study Coordinator, संपर्क, 202-476-5000
भर्ती जारी
Florida
Excel Medical Clinical Trials ( Site 0008), Boca Raton, Florida, 33434, United States
Study Coordinator, संपर्क, 561-529-4356
भर्ती जारी
Georgia
Children's Healthcare of Atlanta Cardiology ( Site 0026), Atlanta, Georgia, 30329, United States
Study Coordinator, संपर्क, 404-256-2593
भर्ती जारी
Victoria
Monash Children s Hospital ( Site 1603), Clayton, Victoria, 3168, Australia
Study Coordinator, संपर्क, +61385723000
भर्ती जारी
Antwerpen
UZ Antwerpen ( Site 0601), Edegem, Antwerpen, 2650, Belgium
Study Coordinator, संपर्क, +323 821 32 51
भर्ती जारी
Ceará
Universidade Federal Do Ceara ( Site 0201), Fortaleza, Ceará, 60430270, Brazil
Study Coordinator, संपर्क, +558533668590
भर्ती जारी
Incor - Instituto do Coracao ( Site 0200), São Paulo, 05403900, Brazil
Study Coordinator, संपर्क, +551126615450
भर्ती जारी
Beijing Municipality
Beijing Anzhen Hospital. Capital Medical University ( Site 1917), Beijing, Beijing Municipality, 100029, China
Study Coordinator, संपर्क, 010-64412431
भर्ती जारी
Zhejiang
The Children's Hospital of Zhejiang University School of Medicine ( Site 1905), Hangzhou, Zhejiang, 310057, China
Study Coordinator, संपर्क, 0571-86036545
भर्ती जारी
Atlántico
Clinica de la Costa S.A.S. ( Site 0400), Barranquilla, Atlántico, 080020, Colombia
Study Coordinator, संपर्क, +57 3133894240
भर्ती जारी
Departamento de Córdoba
Oncomédica S.A.S ( Site 0401), Montería, Departamento de Córdoba, 230002, Colombia
Study Coordinator, संपर्क, +57 3135342052
भर्ती जारी
Santander Department
Fundación Cardiovascular de Colombia ( Site 0402), Piedecuesta, Santander Department, 681017, Colombia
Study Coordinator, संपर्क, +573203400438
भर्ती जारी
Valle del Cauca Department
Fundacion Valle del Lili ( Site 0403), Cali, Valle del Cauca Department, 760032, Colombia
Study Coordinator, संपर्क, +573166237452
भर्ती जारी
Uusimaa
New Childrens Hospital ( Site 0800), Helsinki, Uusimaa, 00029, Finland
Study Coordinator, संपर्क, +358 9 4711
भर्ती जारी
North Holland
Amsterdam UMC, locatie AMC ( Site 1000), Amsterdam, North Holland, 1105 AZ, Netherlands
Study Coordinator, संपर्क, +31205666360
भर्ती जारी
Canterbury
New Zealand Clinical Research (Christchurch) ( Site 1700), Christchurch, Canterbury, 8011, New Zealand
Study Coordinator, संपर्क, NZCR +6433729477
भर्ती जारी
Central Singapore
National University Hospital-Paediatrics ( Site 1800), Singapore, Central Singapore, 117599, Singapore
Study Coordinator, संपर्क, +6567795555
भर्ती जारी
Asturias, Principado de
Hospital Universitario Central de Asturias ( Site 1303), Oviedo, Asturias, Principado de, 33011, Spain
Study Coordinator, संपर्क, +34985108000
भर्ती जारी
Navarre
COMPLEJO HOSPITALARIO DE NAVARRA ( Site 1302), Pamplona, Navarre, 31009, Spain
Study Coordinator, संपर्क, +34660021505
भर्ती जारी
Sheffield Childrens Hospital ( Site 1503), Sheffield, S10 2TH, United Kingdom
Study Coordinator, संपर्क, +441142717000
भर्ती जारी