Actively Recruiting
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
Led by Yuhan Corporation · Updated on 2025-01-07
60
Participants Needed
5
Research Sites
N/A
Total Duration
On this page
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 19 years old or older at the screening visit
- Expected to require parenteral nutrition for more than 3 days
- Voluntarily signed the consent form
You will not qualify if you...
- Expected to survive less than 3 days
- Body mass index (BMI) over 30 kg/m2
- Hypersensitivity to peanut, fish, soy, egg proteins, or investigational drugs
- Difficulty with central venous line
- Judged unsuitable for the trial by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 days
Participants receive a 3-day infusion of either NTCB02-1 or NTCB-C as part of the study treatment.
Daily visits for 3 days (in-person)
Trial Site Locations
Total: 5 locations
1
National Cancer Center
Gyeonggi-do, Goyang-si, South Korea, 10408
Actively Recruiting
2
Chonnam National University Hwasun Hospital
Jeollanam-do, Hwasun-gun, South Korea, 58128
Actively Recruiting
3
Jeonbuk National University Hospital
Jeollabuk-do, Jeonju-si, South Korea, 54907
Actively Recruiting
4
Severance Hospital
Seoul, Seodaemun-gu, South Korea, 03722
Actively Recruiting
5
Seoul National University Bundang
Gyeonggi-do, Seongnam-si, South Korea, 13620
Actively Recruiting
Research Team
J
Jinhyun Choi
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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