Evaluating NTCB02-1 for patients needing parenteral nutrition
Official title: 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
Run by Yuhan Corporation · NCT06625957 · Data updated 2026-11-12
This study is testing a new nutritional treatment called NTCB02-1 to see if it helps patients who need feeding through an IV feel better compared to the standard treatment.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 19 Years and up |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Yuhan Corporation Industry-sponsored |
| Locations | 5 sites (Gyeonggi-do, Goyang-si and 4 other locations) |
| Status | Recruiting |
| Started | December 4, 2024 |
| Main results expected | July 18, 2025 |
| Study ends | July 18, 2025 |
| Registry record updated | January 7, 2025 |
| Trial ID | NCT06625957 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 19 years or older who are expected to need parenteral nutrition for more than three days.
✕Probably not a fit
Patients who are expected to survive less than three days or have a BMI over 30 kg/m2 may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial is a Phase 3, randomized, open-label, multi-center study designed to assess the safety and efficacy of NTCB02-1 compared to NTCB-C in patients who require parenteral nutrition for more than three days. Participants will be randomly assigned to receive either NTCB02-1 or the control treatment, NTCB-C, while their health outcomes will be monitored throughout the trial. The study aims to provide insights into the effectiveness of NTCB02-1 in improving nutritional support for patients unable to consume food orally.
Why it matters
Potential benefit: If successful, this treatment could enhance nutritional support and improve health outcomes for patients requiring long-term parenteral nutrition.
How similar studies have gone: While this approach is being evaluated in this trial, similar studies have shown promise in improving nutritional support for patients requiring parenteral nutrition.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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National Cancer Center
Gyeonggi-do, Goyang-si, South Korea Recruiting -
Chonnam National University Hwasun Hospital
Jeollanam-do, Hwasun-gun, South Korea Recruiting -
Jeonbuk National University Hospital
Jeollabuk-do, Jeonju-si, South Korea Recruiting -
Severance Hospital
Seoul, Seodaemun-gu, South Korea Recruiting -
Seoul National University Bundang
Gyeonggi-do, Seongnam-si, South Korea Recruiting
Study contacts
- Study coordinator: Jinhyun Choi
- Email: clinicaltrials@yuhan.co.kr
- Phone: 8228280850
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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AGE buildup in people starting long-term parenteral nutrition
This study checks whether adults and kids starting long-term parenteral nutrition accumulate more advanced glycation end-products over a year by non-invasive skin measurements.
-
Observing pediatric patients who have stopped using parenteral nutrition
This study looks at children who have stopped using parenteral nutrition to see what health issues they might face afterward and to find out which kids are most at risk.
-
Improving nutrition in critically ill patients with gastrointestinal issues
This study tests if combining two types of nutrition methods can help critically ill patients with gut issues get the right amount of food they need to recover.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.