Parenteral NutritionPhase 3NCT06625931
Clinical Trial to Evaluate the Safety and Efficacy of NTCB01-1 in Patients Who Require Parenteral Nutrition
A Phase 3 study testing NTCB01-1 and NTCB-P in people with Parenteral Nutrition, run by Yuhan Corporation at 7 sites in South Korea.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Parenteral Nutrition
- What is being tested?
- NTCB01-1 and NTCB-P
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 7 sitesSouth Korea
- Study dates
- 14 Nov 2024to 28 Mar 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
7 sites in 1 country.
7 sites in 1 country
South Korea7 sites
Kosin University Gospel Hospital
Busan, Seo-gu, 49267
Keimyung University Dongsan Hospital
Daegu, Dalseo-gu, 42601
Ajou University Medical Center
Gyeonggi-do, Suwon-si, 16499
Seoul Metropolitan Government Seoul National University Boramae Medical Center
Seoul, Dongjak-gu, 07061
Seoul National University Hospital
Seoul, Jongno-gu, 03080
The Catholic University of Korea, Seoul ST. Mary's Hospital
Seoul, Seocho-Gu, 06591
Korea University Anam Hospital
Seoul, Seongbuk-gu, 02841
About this study
Official title: 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
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
- Conditions
- Parenteral Nutrition
- Being tested
- NTCB01-1, NTCB-P
- Medical subject headings
- Hyperphagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NTCB01-1Drug
3 Days infusion
NTCB-PDrug
3 Days infusion
| Study group | Role | What they receive |
|---|---|---|
| NTCB01-1 | Experimental | Not described Receives: Drug: NTCB01-1 |
| NTCB-P | Active comparator | Not described Receives: Drug: NTCB-P |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurance rate of adverse drug reaction
Measured: Day 1 to day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2024
- Study start14 Nov 2024
- Primary completion28 Mar 2025
- Study completion28 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parenteral NutritionStudies of the same condition, open and under way.
- More trials run by Yuhan CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuhan Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06625931
- Sponsor's protocol ID
- NTCB01-301
- Status last verified
- Jan 2025
- First submitted
- 2 Oct 2024
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06625931
- Acronym / sponsor ID
- NTCB01-301
- Conditions
- Parenteral Nutrition
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Yuhan CorporationIndustry (pharma, biotech, devices)
- Study start
- 14 Nov 2024 (actual)
- Primary completion
- 28 Mar 2025 (actual)
- Study completion
- 28 Mar 2025 (actual)
- First posted
- 3 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NTCB01-1 | Experimental | Drug: NTCB01-1 |
| NTCB-P | Active comparator | Drug: NTCB-P |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NTCB01-13 Days infusion | Drug | NTCB01-1 |
| NTCB-P3 Days infusion | Drug | NTCB-P |
Primary outcome
Occurance rate of adverse drug reaction
Time frame: Day 1 to day 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
- Individual participant dataSharing planned: No
Related trials for Parenteral Nutrition
RecruitingPhase 1
First Time in Human Study of Long Acting VH4524184 Formulations
HIV Infections
Active, not recruiting
Compassionate-Use of 4% T-EDTA Lock Solution for Central Venous Lines of Pediatric PN Patients
Central Line Complication, Central Line-associated Bloodstream Infection (CLABSI)
Active, not recruitingPhase 2
Effect of a Parenteral Emulsion With Omega3 on Neonates With PPHN and CDH
Pulmonary Hypertension of Newborn, Diaphragm Defect
RecruitingPhase 4
Initial Triple Therapy Including Parenteral Treprostinil vs Initial Double Oral Therapy in PAH Group I Patients
Pulmonary Arterial Hypertension
Active, not recruitingPhase 3
Efficacy and Safety of PJ009 in Patients With Short Bowel Syndrome Requiring Parenteral Nutrition
Short Bowel Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing NTCB01-1 and NTCB-P in people with Parenteral Nutrition, run by Yuhan Corporation at 7 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurance rate of adverse drug reaction (time frame: Day 1 to day 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2025.