Clinical trial Recruiting at 5 sites Phase 3 Interventional Ages 19 and up

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

PhasePhase 3
Study typeInterventional
Ages19 Years and up
SexAll
Enrollment60 (estimated)
SponsorYuhan Corporation
Industry-sponsored
Locations5 sites (Gyeonggi-do, Goyang-si and 4 other locations)
StatusRecruiting
StartedDecember 4, 2024
Main results expectedJuly 18, 2025
Study endsJuly 18, 2025
Registry record updatedJanuary 7, 2025
Trial IDNCT06625957 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

  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.