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Recruiting Phase 3 NCT06625957
Clinical Trial to Evaluate the Safety and Efficacy of NTCB02-1 in Patients Who Require Parenteral Nutrition
Trial Parameters
Condition Parenteral Nutrition
Sponsor Yuhan Corporation
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 60
Sex ALL
Min Age 19 Years
Max Age N/A
Start Date 2024-12-04
Completion 2025-07-18
Interventions
NTCB02-1NTCB-C
Brief Summary
A Randomized, Open-labeled, Multi-center, Active-controlled, Parallel-group Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of NTCB02-1 versus NTCB-C in patients who require parenteral nutrition
Eligibility Criteria
Inclusion Criteria: * Those who are 19 years old or older at the screening visit * Patients are expected to require PN for more than 3 days * Patients who voluntarily signed the consent form Exclusion Criteria: * Patients are expected difficult to survive more than 3 days * Patients BMI is over 30 kg/m2 * Patients having hypersensitivity to any peanut-, fish-, soy-, egg protein, or investigational drug * Patients with difficult central venous line * Patients judged to be unsuitable for this trial by investigators
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