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

Last updated: January 5, 2025
Sponsor: Yuhan Corporation
Overall Status: Active - Recruiting

Phase

3

Condition

Diet And Nutrition

Treatment

NTCB02-1

NTCB-C

Clinical Study ID

NCT06625957
NTCB02-301
  • Ages > 19
  • All Genders

Study 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 Criteria

Inclusion

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

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, orinvestigational drug

  • Patients with difficult central venous line

  • Patients judged to be unsuitable for this trial by investigators

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: NTCB02-1
Phase: 3
Study Start date:
December 04, 2024
Estimated Completion Date:
July 18, 2025

Connect with a study center

  • National Cancer Center

    Gyeonggi-do, Goyang-si 10408
    Korea, Republic of

    Active - Recruiting

  • Chonnam National University Hwasun Hospital

    Jeollanam-do, Hwasun-gun 58128
    Korea, Republic of

    Active - Recruiting

  • Jeonbuk National University Hospital

    Jeollabuk-do, Jeonju-si 54907
    Korea, Republic of

    Active - Recruiting

  • Severance Hospital

    Seoul, Seodaemun-gu 03722
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Bundang

    Gyeonggi-do, Seongnam-si 13620
    Korea, Republic of

    Active - Recruiting

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