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

NCT ID: NCT06625957

Last Updated: 2025-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-04

Study Completion Date

2025-07-18

Brief Summary

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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

Detailed Description

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Conditions

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Parenteral Nutrition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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NTCB02-1

Group Type EXPERIMENTAL

NTCB02-1

Intervention Type DRUG

3 Days infusion

NTCB-C

Group Type ACTIVE_COMPARATOR

NTCB-C

Intervention Type DRUG

3 Days infusion

Interventions

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NTCB02-1

3 Days infusion

Intervention Type DRUG

NTCB-C

3 Days infusion

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yuhan Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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National Cancer Center

Gyeonggi-do, Goyang-si, South Korea

Site Status RECRUITING

Chonnam National University Hwasun Hospital

Jeollanam-do, Hwasun-gun, South Korea

Site Status RECRUITING

Jeonbuk National University Hospital

Jeollabuk-do, Jeonju-si, South Korea

Site Status RECRUITING

Severance Hospital

Seoul, Seodaemun-gu, South Korea

Site Status RECRUITING

Seoul National University Bundang

Gyeonggi-do, Seongnam-si, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Jinhyun Choi

Role: CONTACT

8228280850

Other Identifiers

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NTCB02-301

Identifier Type: -

Identifier Source: org_study_id

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