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RecruitingNCT06625957Updated Jan 7, 2025

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

A Phase 3 interventional study of NTCB02-1 and NTCB-C in Parenteral Nutrition, sponsored by Yuhan Corporation. Recruiting at 5 sites in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2025-01-07.

Sponsored by Yuhan Corporation · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

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

02

Conditions studied

  • Parenteral Nutrition
03

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    NTCB02-1

    Drug: NTCB02-1

  • Active comparator
    NTCB-C

    Drug: NTCB-C

Interventions

  • DrugNTCB02-1

    3 Days infusion

  • DrugNTCB-C

    3 Days infusion

05

What researchers measure

Primary outcomes

  1. Occurance rate of adverse drug reaction

    Time frame: Day 1 to day 4

06

Study locations

5 of 5 sites recruiting
  • National Cancer Center
    Gyeonggi-do, Goyang-si 10408, Korea, Republic of
    Recruiting
  • Chonnam National University Hwasun Hospital
    Jeollanam-do, Hwasun-gun 58128, Korea, Republic of
    Recruiting
  • Jeonbuk National University Hospital
    Jeollabuk-do, Jeonju-si 54907, Korea, Republic of
    Recruiting
  • Severance Hospital
    Seoul, Seodaemun-gu 03722, Korea, Republic of
    Recruiting
  • Seoul National University Bundang
    Gyeonggi-do, Seongnam-si 13620, Korea, Republic of
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06625957
Lead sponsor
Yuhan Corporation
Responsible party
Sponsor
First posted
Oct 3, 2024
Start date
Dec 4, 2024
Primary completion
Jul 18, 2025 (estimated)
Completion
Jul 18, 2025 (estimated)
Last update
Jan 7, 2025

Study contacts

Jinhyun Choi
Contact
clinicaltrials@yuhan.co.kr
8228280850

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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