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

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

Study Overview

• Status: Recruiting
• Conditions: Parenteral Nutrition
• Intervention / Treatment: Drug: NTCB02-1; Drug: NTCB-C

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Jinhyun Choi; Phone Number: 8228280850; Email: clinicaltrials@yuhan.co.kr

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NTCB02-1	Drug: NTCB02-1; 3 Days infusion
Active Comparator: NTCB-C	Drug: NTCB-C; 3 Days infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Occurance rate of adverse drug reaction	Day 1 to day 4

Collaborators and Investigators

• Sponsor: Yuhan Corporation

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2024
• Primary Completion (Estimated): July 18, 2025
• Study Completion (Estimated): July 18, 2025

Study Registration Dates

• First Submitted: October 2, 2024
• First Submitted That Met QC Criteria: October 2, 2024
• First Posted (Actual): October 3, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 5, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; 2-nitro-5-thiocyanobenzoic acid
• Other Study ID Numbers: NTCB02-301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No