A Study to Investigate the Safety and Efficacy of Undiluted Intravenous Infusion of I.V.-Hepabig Inj.

Официальное название

A Phase 3b Study to Investigate the Safety and Efficacy of Undiluted Intravenous Infusion of I.V.-Hepabig Inj. in Post-liver Transplant Patients

Обзор

The purpose of this study is to evaluate the efficacy and safety of undiluted intravenous infusion of I.V.-Hepabig inj. in post-liver transplant patients

Вмешательства

• Биопрепарат Undiluted I.V.-Hepabig inj(GC5103)
  undiluted I.V.-Hepabig inj(GC5103) 10,000 International Unit
• Биопрепарат Diluted I.V.-Hepabig inj(GC5103)
  Diluted I.V.-Hepabig inj(GC5103) 10,000 International Unit

Первичные конечные точки

• Adverse events occurred during clinical trials [Срок оценки: during 20 weeks post first Investigational product administration]

Вторичные конечные точки (7)

• Positive rate of Hepatitis B Surface Antigen(HBsAg) [Срок оценки: Screening, 0, 4, 8, 12, 16, and 20 weeks]
• Hepatitis B Surface Antibody(Anti HBs) titer [Срок оценки: Screening, 0, 4, 8, 12, 16, and 20 weeks]
• Positive rate of Hepatitis B e Antigen(HBeAg) [Срок оценки: Screening, 0, 4, 8, 12, 16, and 20 weeks]
• Positive rate of Hepatitis B Virus DNA(HBV DNA) [Срок оценки: Screening, 0, 4, 8, 12, 16, and 20 weeks]
• Laboratory tests [Срок оценки: Screening, 0, 4, 8, 12, 16, and 20 weeks]
• Vital signs [Срок оценки: Screening, 0, 4, 8, 12, 16, and 20 weeks]
• Physical examination [Срок оценки: Screening, 0, 4, 8, 12, 16, and 20 weeks]

Критерии участия

Критерии включения

• Aged ≥18 and <65 years at the time of signing the consent form
• Subjects who had history of liver transplantation due to HBV-related end-stage liver disease such as cirrhosis, liver cancer and fulminant hepatic failure and received treatment for prevent hepatitis B recurrence
• HBsAg(+) before liver transplantation
• Subjects who have been received I.V.-Hepabig inj more than 3 times dose of 10,000International Unit/4weeks regimen

Критерии исключения

• Subject with history of anaphylaxis to any component of the investigational product
• Pregnant or breast-feeding women
• Deficiency of Immunoglobulin A
• Clinically significant renal diseases (serum creatinine >2.0mg/dL, anuria, renal failure or on dialysis at screening)
• Hemophilia
• Co-infection with Hepatitis A Virus, Hepatitis C Virus, or Human Immunodeficiency Virus
• Subject with history of malignancy within the last 5 years (excluding primary liver cancer)
• Subject received estrogen or hormone replacement therapy within 3 months before screening
• HBsAg or HBeAg or HBV DNA positive at screening
• Anti HBs titer less than below criteria at screening <150 IU/L for subject whose HBeAg and HBV DNA were negative(-) before liver transplantation >500 IU/L for subject whose HBeAg or HBV DNA were positive(+) before liver transplantation
• Subject with history of drug abuse
• Participated in another clinical study within 30 days (relative to the last dose of investigational product) before screening
• Subject who are determined disqualified to join clinical trials by investigator

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

South Korea · 8 центров

• National Cancer Center — Goyang-si
• Ajou University Medical Center — Suwon
• Asan Medical Center — Seoul
• Inje University Haeundae Paik Hospital — Busan
• Chungnam National University Hospital — Daejeon
• Seoul National University Hospital — Seoul
• Severance Hospital — Seoul
• Samsung Medical Center — Seoul

Идентификаторы

NCT: NCT05686759 · GC5103-003_UDIV_P3b01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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