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

Last updated: June 18, 2025
Sponsor: GC Biopharma Corp
Overall Status: Active - Recruiting

Phase

3

Condition

Hepatitis

Hepatitis B

Treatment

Undiluted I.V.-Hepabig inj(GC5103)

Diluted I.V.-Hepabig inj(GC5103)

Clinical Study ID

NCT05686759
GC5103-003_UDIV_P3b01
  • Ages 18-64
  • All Genders

Study 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

Inclusion Criteria:

  1. Aged ≥18 and <65 years at the time of signing the consent form

  2. Subjects who had history of liver transplantation due to HBV-related end-stage liverdisease such as cirrhosis, liver cancer and fulminant hepatic failure and receivedtreatment for prevent hepatitis B recurrence

  3. HBsAg(+) before liver transplantation

  4. Subjects who have been received I.V.-Hepabig inj more than 3 times dose of 10,000International Unit/4weeks regimen

Exclusion

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, renalfailure or on dialysis at screening)

  5. Hemophilia

  6. Co-infection with Hepatitis A Virus, Hepatitis C Virus, or Human ImmunodeficiencyVirus

  7. Subject with history of malignancy within the last 5 years (excluding primary livercancer)

  8. Subject received estrogen or hormone replacement therapy within 3 months beforescreening

  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 whoseHBeAg and HBV DNA were negative(-) before liver transplantation >500 IU/L forsubject whose HBeAg or 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 ofinvestigational product) before screening

  13. Subject who are determined disqualified to join clinical trials by investigator

Study Design

Total Participants: 105
Treatment Group(s): 2
Primary Treatment: Undiluted I.V.-Hepabig inj(GC5103)
Phase: 3
Study Start date:
April 13, 2023
Estimated Completion Date:
June 30, 2026

Connect with a study center

  • National Cancer Center

    Goyang-si, Gyeonggi-do 10408
    Korea, Republic of

    Active - Recruiting

  • Ajou University Medical Center

    Suwon, Gyeonggi-do 16499
    Korea, Republic of

    Active - Recruiting

  • Inje University Haeundae Paik Hospital

    Busan, 48108
    Korea, Republic of

    Active - Recruiting

  • Chungnam National University Hospital

    Daejeon, 35015
    Korea, Republic of

    Active - Recruiting

  • Asan Medical Center

    Seoul, 05505
    Korea, Republic of

    Active - Recruiting

  • Samsung Medical Center

    Seoul, 06351
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Hospital

    Seoul, 03080
    Korea, Republic of

    Active - Recruiting

  • Severance Hospital

    Seoul, 03722
    Korea, Republic of

    Active - Recruiting

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