Clinical Trial to Evaluate the Safety and Efficacy of NTCB01-1 in Patients Who Require Parenteral Nutrition

Phase 3

Recruiting

• Conditions: Parenteral Nutrition
• Interventions: Drug: NTCB01-1; Drug: NTCB-P

• Registration Number: NCT06625931
• Lead Sponsor: Yuhan Corporation

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-02
• Study First Submitted QC: 2024-10-02
• Study First Posted: 2024-10-03
• Study Start: 2024-11-14
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-05
• Last Update Posted: 2025-01-07
• Primary Completion: 2025-07-11
• Study Completion: 2025-07-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NTCB01-1	NTCB01-1	-
NTCB-P	NTCB-P	-

Primary Outcome Measures

Name	Time	Method
Occurance rate of adverse drug reaction	Day 1 to day 4

Trial Locations

Locations (7)

Keimyung University Dongsan Hospital; 🇰🇷 Daegu, Dalseo-gu, Korea, Republic of

Seoul Metropolitan Government Seoul National University Boramae Medical Center; 🇰🇷 Seoul, Dongjak-gu, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Jongno-gu, Korea, Republic of

Kosin University Gospel Hospital; 🇰🇷 Busan, Seo-gu, Korea, Republic of

The Catholic University of Korea, Seoul ST. Mary's Hospital; 🇰🇷 Seoul, Seocho-Gu, Korea, Republic of

Korea University Anam Hospital; 🇰🇷 Seoul, Seongbuk-gu, Korea, Republic of

Ajou University Medical Center; 🇰🇷 Gyeonggi-do, Suwon-si, Korea, Republic of