Actively Recruiting
Phase 3 Study Comparing NTCB02-1 and NTCB-C Drugs for Patients Needing Parenteral Nutrition
Led by Yuhan Corporation · Updated on 2025-01-07
60
Participants Needed
5
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of two drugs, NTCB02-1 and NTCB-C, in patients who need parenteral nutrition, which means receiving nutrition through an intravenous line. This is a Phase 3 clinical trial that compares these two treatments in a randomized, open-label, multi-center, and parallel-group design to better understand their safety profiles and efficacy. Participants will receive an infusion of either NTCB02-1 or NTCB-C for three days. The study is actively controlled, meaning each participant receives one of the two treatments being studied. The trial is randomized, so participants are assigned by chance to one of the two groups, and it is open-labeled, so both participants and researchers know which treatment is given. During the study, participants will be monitored closely from day 1 to day 4 for any adverse drug reactions. Researchers will collect data on safety and treatment responses. The total duration and exact follow-up procedures are based on the treatment period and immediate safety monitoring. The study aims to provide detailed safety information about these treatments in patients requiring parenteral nutrition.
CONDITIONS
Brief Title
Clinical Trial to Evaluate the Safety and Efficacy of NTCB02-1 in Patients Who Require Parenteral Nutrition
Research Team
J
Jinhyun Choi
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