Actively Recruiting
Study of NTCB02-1 Compared to NTCB-C in Patients Needing Parenteral Nutrition A Randomized, Open-label, Active-Controlled Phase 3 Trial Evaluating Safety and Efficacy with 3-Day Infusions
Led by Yuhan Corporation · Updated on 2025-01-07
60
Participants Needed
5
Research Sites
32 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a Phase 3 randomized, open-label, multi-center clinical trial to evaluate the safety and effectiveness of two treatments, NTCB02-1 and NTCB-C, in patients who require parenteral nutrition. This study compares these two active drugs to see how well they work and how safe they are for patients needing nutrition delivered intravenously. Participants will receive either NTCB02-1 or NTCB-C through a 3-day infusion. The study is designed with parallel groups, meaning participants are randomly assigned to one of the two treatment options, and the treatments are given openly without blinding. During the study, patients will be monitored for any adverse drug reactions from day 1 to day 4. Researchers will assess safety and treatment responses during this period to understand the occurrence rate of any side effects. The trial focuses on patients expected to need parenteral nutrition for more than three days, with involvement lasting at least through the initial treatment and observation period.
CONDITIONS
Official 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...
- Age 19 years or older at screening visit
- Expected need for parenteral nutrition for more than 3 days
- Voluntarily signed informed consent form
You will not qualify if you...
- Expected survival less than 3 days
- Body mass index (BMI) over 30 kg/m2
- Hypersensitivity to peanut, fish, soy, egg proteins, or investigational drugs
- Difficulties with central venous line
- Judged unsuitable for the trial by investigators
AI-Screening
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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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