RecruitingPhase 3NCT06625957

Clinical Trial to Evaluate the Safety and Efficacy of NTCB02-1 in Patients Who Require 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


Sponsor

Yuhan Corporation

Enrollment

60 participants

Start Date

Dec 4, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 19 Years

Inclusion Criteria3

  • 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 Criteria5

  • 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

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Interventions

DRUGNTCB02-1

3 Days infusion

DRUGNTCB-C

3 Days infusion


Locations(5)

National Cancer Center

Gyeonggi-do, Goyang-si, South Korea

Chonnam National University Hwasun Hospital

Jeollanam-do, Hwasun-gun, South Korea

Jeonbuk National University Hospital

Jeollabuk-do, Jeonju-si, South Korea

Severance Hospital

Seoul, Seodaemun-gu, South Korea

Seoul National University Bundang

Gyeonggi-do, Seongnam-si, South Korea

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NCT06625957


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