Clinical trial NCT05686759: A Study to Investigate the Safety and Efficacy of Undiluted Intravenous Infusion of I.V.-Hepabig Inj.
Official title: A Phase 3b Study to Investigate the Safety and Efficacy of Undiluted Intravenous Infusion of I.V.-Hepabig Inj. in Post-liver Transplant Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Hepatitis B
Keywords: Hepatitis B
Liver Transplantation
Hepatitis B Immunoglobulin
Liver Diseases
Lead sponsor: GC Biopharma Corp
Sponsor class: INDUSTRY
First posted: 2023-01-17
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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


Eligibility criteria: Inclusion Criteria:

1. Aged ≥19 and ≤65 years at the time of signing the consent form
2. HBsAg(+) before liver transplantation
3. 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
4. Subjects who have been received I.V.-Hepabig inj more than 3 times dose of 10,000International Unit/4weeks regimen, and whole duration of administration of I.V.-Hepabig ing will not be exceeded 1 year while participating this study

Exclusion Criteria:

1. Subject with history of anaphylaxis to any component of the investigational product
2. Pregnant or breast-feeding women
3. Deficiency of Immunoglobulin A
4. Clinically significant renal diseases (serum creatinine \>2.0mg/dL, anuria, renal failure or on dialysis at screening)
5. Hemophilia
6. Co-infection with Hepatitis A Virus, Hepatitis C Virus, or Human Immunodeficiency Virus
7. Subject with history of malignancy within the last 5 years (excluding primary liver cancer)
8. Subject received estrogen or hormone replacement therapy within 3 months before screening
9. HBsAg or HBeAg or HBV DNA positive at screening
10. 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 and HBV DNA were positive(+) before liver transplantation
11. Subject with history of drug abuse
12. Participated in another clinical study within 30 days (relative to the last dose of investigational product) before screening
13. Subject who are determined disqualified to join clinical trials by investigator

Primary outcomes:
measure: Adverse events occurred during clinical trials
timeFrame: during 20 weeks post first Investigational product administration
Secondary outcomes:
measure: Positive rate of Hepatitis B Surface Antigen(HBsAg)
timeFrame: Screening, 0 4, 8, 12, 16, and 20 weeks
measure: Hepatitis B Surface Antibody(Anti HBs) titer
timeFrame: Screening, 0 4, 8, 12, 16, and 20 weeks
measure: Positive rate of Hepatitis B e Antigen(HBeAg)
timeFrame: Screening,0 4, 8, 12, 16, and 20 weeks
measure: Positive rate of Hepatitis B Virus DNA(HBV DNA)
timeFrame: Screening, 0 4, 8, 12, 16, and 20 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
References: