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

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

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-14

Study Completion Date

2025-03-28

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 NTCB01-1 versus NTCB-P in patients who require parenteral nutrition

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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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NTCB01-1

Group Type EXPERIMENTAL

NTCB01-1

Intervention Type DRUG

3 Days infusion

NTCB-P

Group Type ACTIVE_COMPARATOR

NTCB-P

Intervention Type DRUG

3 Days infusion

Interventions

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NTCB01-1

3 Days infusion

Intervention Type DRUG

NTCB-P

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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No