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NCT06625931 | NOT YET RECRUITING | Parenteral Nutrition

Clinical Trial to Evaluate the Safety and Efficacy of NTCB01-1 in Patients Who Require Parenteral Nutrition
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 NTCB01-1 versus NTCB-P in patients who require parenteral nutrition

Condition or disease

Parenteral Nutrition

Intervention/treatment

NTCB01-1

NTCB-P

Phase

PHASE3

Study Type : INTERVENTIONAL
Estimated Enrollment : 60 participants
Masking : NONE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2024-12-27
Estimated Primary Completion Date : 2025-07-11
Estimated Study Completion Date : 2025-07-11

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 19 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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 peripheral intravenous
  • * Patients judged to be unsuitable for this trial by investigators
Clinical Trial to Evaluate the Safety and Efficacy of NTCB01-1 in Patients Who Require Parenteral Nutrition

Location Details

NCT06625931

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

Korea, Republic of, Dalseo-we

Keimyung University Dongsan Hospital

Daegu, Dalseo-we Korea, Republic of, 42601

Not yet recruiting

Korea, Republic of, Dongjak-gu

Seoul Metropolitan Government Seoul National University Boramae Medical Center

Seoul, Dongjak-gu, Korea, Republic of, 07061

Not yet recruiting

Korea, Republic of, Jongno-gu

Seoul National University Hospital

Seoul, Jongno-gu, Korea, Republic of, 03080

Not yet recruiting

Korea, Republic of, Here-to

Kosin University Gospel Hospital

Busan, here-to, Korea, Republic of, 49267

Not yet recruiting

Korea, Republic of, Seocho-Gu

The Catholic University of Korea, Seoul ST. Mary's Hospital

Seoul, Seocho-Gu, Korea, Republic of, 06591

Not yet recruiting

Korea, Republic of, Seongbuk-gu

Korea University Anam Hospital

Seoul, Seongbuk-gu, Korea, Republic of, 02841

Not yet recruiting

Korea, Republic of, Cheaper

Ajou University Medical Center

Gyeonggi-do, More and more, Korea, Republic of, 16499