NCT06625931

Brief Summary

A Randomized, Open-labeled, Multi-center, Active-controlled, Parallel-group Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of NTCB01-1 versus NTCB-P in patients who require parenteral nutrition

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2024

Shorter than P25 for phase_3

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 2, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 3, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

November 14, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2025

Completed
Last Updated

May 15, 2025

Status Verified

January 1, 2025

Enrollment Period

4 months

First QC Date

October 2, 2024

Last Update Submit

May 14, 2025

Conditions

Parenteral Nutrition

Outcome Measures

Primary Outcomes (1)

  • Occurance rate of adverse drug reaction

    Day 1 to day 4

Study Arms (2)

NTCB01-1

EXPERIMENTAL
Drug: NTCB01-1

NTCB-P

ACTIVE COMPARATOR
Drug: NTCB-P

Interventions

NTCB01-1DRUG

3 Days infusion

NTCB01-1
NTCB-PDRUG

3 Days infusion

NTCB-P

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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 peripheral intravenous line
  • Patients judged to be unsuitable for this trial by investigators

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Keimyung University Dongsan Hospital

Daegu, Dalseo-gu, 42601, South Korea

Location

Seoul Metropolitan Government Seoul National University Boramae Medical Center

Seoul, Dongjak-gu, 07061, South Korea

Location

Seoul National University Hospital

Seoul, Jongno-gu, 03080, South Korea

Location

Kosin University Gospel Hospital

Busan, Seo-gu, 49267, South Korea

Location

The Catholic University of Korea, Seoul ST. Mary's Hospital

Seoul, Seocho-Gu, 06591, South Korea

Location

Korea University Anam Hospital

Seoul, Seongbuk-gu, 02841, South Korea

Location

Ajou University Medical Center

Gyeonggi-do, Suwon-si, 16499, South Korea

Location

MeSH Terms

Conditions

Hyperphagia

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2024

First Posted

October 3, 2024

Study Start

November 14, 2024

Primary Completion

March 28, 2025

Study Completion

March 28, 2025

Last Updated

May 15, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

KR(7)