Clinical Trial to Evaluate the Safety and Efficacy of NTCB02-1 in Patients Who Require Parenteral Nutrition
Phase 3
Recruiting
- Conditions
- Parenteral Nutrition
- Interventions
- Drug: NTCB02-1Drug: NTCB-C
- Registration Number
- NCT06625957
- Lead Sponsor
- Yuhan Corporation
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
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
Read More
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
Read More
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description NTCB02-1 NTCB02-1 - NTCB-C NTCB-C -
- Primary Outcome Measures
Name Time Method Occurance rate of adverse drug reaction Day 1 to day 4
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (5)
National Cancer Center
🇰🇷Gyeonggi-do, Goyang-si, Korea, Republic of
Chonnam National University Hwasun Hospital
🇰🇷Jeollanam-do, Hwasun-gun, Korea, Republic of
Jeonbuk National University Hospital
🇰🇷Jeollabuk-do, Jeonju-si, Korea, Republic of
Severance Hospital
🇰🇷Seoul, Seodaemun-gu, Korea, Republic of
Seoul National University Bundang
🇰🇷Gyeonggi-do, Seongnam-si, Korea, Republic of