Evaluating NTCB02-1 for patients needing parenteral nutrition
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
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 |
| Enrollment | 60 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Yuhan Corporation Industry-sponsored |
| Locations | 5 sites (Gyeonggi-do, Goyang-si and 4 other locations) |
| Trial ID | NCT06625957 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: While this approach is being evaluated in this trial, similar studies have shown promise in improving nutritional support for patients requiring parenteral nutrition.
Eligibility criteria
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 this trial is running
Gyeonggi-do, Goyang-si and 4 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.