Clinical Trial to Evaluate the Safety and Efficacy of NTCB02-1 in Patients Who Require Parenteral Nutrition
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: NTCB02-1, NTCB-C.
- Who it may be relevant to
- Registry conditions: Parenteral Nutrition. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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
Overview
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
Interventions
- Drug NTCB02-1
3 Days infusion - Drug NTCB-C
3 Days infusion
Primary outcome measures
- Occurance rate of adverse drug reaction [Time frame: Day 1 to day 4]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
South Korea · 5 centers
- National Cancer Center — Gyeonggi-do
- Chonnam National University Hwasun Hospital — Jeollanam-do
- Jeonbuk National University Hospital — Jeollabuk-do
- Severance Hospital — Seoul
- Seoul National University Bundang — Gyeonggi-do
Identifiers
NCT: NCT06625957 · NTCB02-301