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

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

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Key information

Conditions

Parenteral Nutrition Hyperphagia Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

National Cancer Center, Gyeonggi-do, Goyang-si, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NTCB02-1

Drug

3 Days infusion

NTCB-C

Drug

3 Days infusion

Primary outcomes

Occurance rate of adverse drug reaction

Time frame: Day 1 to day 4

Study contacts

Contact information is provided by the study sponsor or research team.

Jinhyun Choi

CONTACT

[email protected]

8228280850

Sponsors and collaborators

Lead sponsor

Yuhan Corporation

Industry

Registry information

Official study title

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

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Oct 3, 2024
Registry last updated: Jan 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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