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

ConditionParenteral Nutrition

Trial statusRecruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age19+

SponsorYuhan Corporation

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

NTCB02-1
Drug
3 Days infusion
NTCB-C
Drug
3 Days infusion

Treatment groups

60 Participants

are divided into 2 treatment groups

Group A: NTCB02-1Experimental treatment 1 intervention

Group B: NTCB-CActive comparator 1 intervention

Trial outcomes

Primary outcomes

Occurance rate of adverse drug reaction

Time frame

Day 1 to day 4

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yuhan Corporation

Lead sponsor

Source ClinicalTrials.gov

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