ClinicalTrials.gg
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

From the registry’s dates

  • Primary completion was expected by Jul 2025, 1 year 3 months ago, but the record still lists the study as recruiting.
  • Started Dec 2024; still recruiting 1 year 11 months later.
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

In context

Lead sponsor

Yuhan Corporation is the lead sponsor of 110 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 is over 30 kg/m2
  • Patients having to any peanut-, fish-, soy-, egg protein, or drug
  • Patients with difficult central venous line
  • Patients judged to be unsuitable for this trial by investigators
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

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

06

What researchers measure

Primary outcomes

  1. Occurance rate of adverse drug reaction

    Time frame: Day 1 to day 4

07

Study locations

5 of 5 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Dec 2024 (actual). Primary completion is estimated for Jul 2025, 7 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 2, 2024
First posted
Oct 3, 2024
StartActual
Dec 4, 2024
Primary completionEst.
Jul 18, 2025
CompletionEst.
Jul 18, 2025
Last update
Jan 7, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 7, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

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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