NCT02304315

Brief Summary

This is a proof-of-concept study for GC1102 to demonstrate preventing the recurrence of hepatitis B virus (HBV) infection following liver transplantation and a dose-finding study to determine its optional dose.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2015

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 26, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 1, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

June 30, 2016

Status Verified

December 1, 2015

Enrollment Period

1.2 years

First QC Date

November 26, 2014

Last Update Submit

June 29, 2016

Conditions

Hepatitis B Infection

Keywords

HBV-related liver transplantationHepatitis B Immuno Globulin

Outcome Measures

Primary Outcomes (1)

  • Recurrence rate of Hepatitis B

    Seroconversion rate of HBsAg or HBeAg

    28 weeks

Secondary Outcomes (7)

  • Seroconversion rate of HBsAg or HBeAg

    28 weeks

  • Seroconversion time of HBsAg or HBeAg

    28 weeks

  • Overall survival rate

    28 weeks

  • Geometric mean titer (GMT) of HBV DNA

    Day 6, 28, 59, 84, 112, 140, 158, 196

  • Histological findings of hepatic graft

    Baseline

  • +2 more secondary outcomes

Other Outcomes (4)

  • Adverse events

    28 weeks

  • Clinical abnormalities in physical exam, vital signs, and/or laboratory

    28 weeks

  • Infusion reactions

    72 hours

  • +1 more other outcomes

Study Arms (2)

GC1102 50,000 IU

EXPERIMENTAL

Anhepatic phase: 50,000 IU intravenous during surgery, Post-transplantation(1st week): 50,000 IU intravenous every day, Post-transplantation(2nd-4th weeks): 50,000 IU intravenous every weeks, Post-transplantation(8th weeks and till 24 weeks): 50,000 IU intravenous every 4 weeks.

Biological: GC1102 50,000 IU

GC1102 80,000 IU

EXPERIMENTAL

Anhepatic phase: 80,000 IU intravenous during surgery, Post-transplantation(1st week): 80,000 IU intravenous every day, Post-transplantation(2nd-4th weeks): 80,000 IU intravenous every weeks, Post-transplantation(8th weeks and till 24 weeks): 80,000 IU intravenous every 4 weeks.

Biological: GC1102 80,000 IU

Interventions

GC1102 50,000 IUBIOLOGICAL

a recombinant hepatitis B immunoglobulin

GC1102 50,000 IU
GC1102 80,000 IUBIOLOGICAL

a recombinant hepatitis B immunoglobulin

GC1102 80,000 IU

Eligibility Criteria

Age19 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Given written informed consent
  • Aged 19 - 65 years
  • Expected liver transplantation related to hepatitis B
  • Positive HBsAg

You may not qualify if:

  • Patients has participated in any other clinical trial within 30 days
  • Patients who are scheduled re-operation for liver transplantation
  • Patients with are co-infected with HAV, HCV or HIV
  • History of malignant tumor within 5 years except primary liver cancer
  • Patients with moderate or severe renal disorder (serum creatinine \> 1.5 X ULM) or anuria, acute renal failure or dialysis
  • Patients who had experienced cardiovascular attack, myocardiac infarction, PTCA or coronary bypass or with angina, arrhythmia, or any other clinically meaningful valvular heart disease, cerebral infarction or cerebral hemorrhage within 6 months
  • History of anaphylaxis against active ingredient or excipients of study drug
  • Patients who had been vaccinated with parenteral live vaccine (measles vaccine, epidemic parotitis vaccine, rubella vaccine, cholera vaccine, chickenpox vaccine) within 3 months
  • Patients who had been treated with any other immuno globulin within 3 months
  • Pregnant or breast-feeding women
  • Women of childbearing potential who do not agree to use appropriate contraceptive methods (condom, an intrauterine device, oral contraceptive hormones, or a vasectomy of male sex partner) during this study
  • Alcohol or drug abuse within 6 months
  • Patients who has any clinically meaningful disease in investigator's judgement to prevent participating in this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul Asan Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Hepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System Diseases

Study Officials

  • Sung-Gyu Lee, M.D.

    Seoul Asan Medical Center

    PRINCIPAL INVESTIGATOR

  • Chang-Hee Lee, M.D.

    GC Biopharma Corp

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 26, 2014

First Posted

December 1, 2014

Study Start

February 1, 2015

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

June 30, 2016

Record last verified: 2015-12

Locations

KR(1)