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

Yuhan

Status and phase: Completed; Phase 3

Conditions: Parenteral Nutrition

Treatments: Drug: NTCB-P; Drug: NTCB01-1

Study type: Interventional

Funder types: Industry

Identifiers

NCT06625931

NTCB01-301

Details and patient eligibility

About

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

Enrollment: 60 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

NTCB01-1

Experimental group

Treatment:

Drug: NTCB01-1

NTCB-P

Active Comparator group

Treatment:

Drug: NTCB-P