NCT03519113

Brief Summary

This is a clinical 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

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
186

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2018

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 20, 2018

Completed
9 days until next milestone

Study Start

First participant enrolled

March 29, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 8, 2018

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

January 30, 2020

Status Verified

October 1, 2019

Enrollment Period

4 years

First QC Date

March 20, 2018

Last Update Submit

January 29, 2020

Conditions

Hepatitis B Infection

Keywords

HBV-related liver transplantationHepatitis B immunoglobulin

Outcome Measures

Primary Outcomes (1)

  • Prevention Failure rate of HBV

    Seroconversion rate of HBsAg or HBeAg, anti-HBs \< 500 IU/L

    28weeks

Secondary Outcomes (6)

  • Recurrence rate of HBV

    28weeks

  • Prophylactic failure rate of HBV

    28weeks

  • Recurrence duration

    28weeks

  • Overall survival rate

    1 year

  • Geometric mean titer of HBV DNA

    1 year

  • +1 more secondary outcomes

Other Outcomes (7)

  • Pharmacokinetic(PK) parameters

    1 year

  • Area under curve(AUC)

    1 year

  • clearance(CL)

    1 year

  • +4 more other outcomes

Study Arms (3)

Test group 1

EXPERIMENTAL

GC1102 80,000 IU

Biological: GC1102 80,000 IU

Test group 2

EXPERIMENTAL

GC1102 100,000 IU

Biological: GC1102 100,000 IU

Control group

ACTIVE COMPARATOR

I.V HBIG

Biological: I.V HBIG

Interventions

GC1102 80,000 IUBIOLOGICAL

recombinant human hepatitis B immunoglobulin

Test group 1
GC1102 100,000 IUBIOLOGICAL

recombinant human hepatitis B immunoglobulin

Test group 2
I.V HBIGBIOLOGICAL

human anti-hepatitis B Immunoglobulin

Control group

Eligibility Criteria

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

You may qualify if:

  • Subject who was informed of, and fully understood, all aspects of the study and has provided voluntary written consent for participation in the study
  • Subject aged over 19 years at the time of consent provided
  • Subject with planned liver transplantation due to HBV-related end-stage liver disease such as cirrhosis, liver cancer and fulminant hepatic failure
  • Subject with HBsAg(+)

You may not qualify if:

  • Subject with planned reoperation following liver transplantation
  • Subject with hemophilia
  • Subject with a history of venous or arterial thrombosis
  • Subject with HAV, HCV or HIV infection
  • Subject with immunodeficiency or immunosuppression due to whole body steroids before liver transplantation
  • Subject with hemolytic or blood loss anemia
  • Subject with IgA deficiency
  • Subject with a history of malignant tumor within the last 5 years, excluding primary liver cancer
  • Subject with moderate to severe kidney disease (serum creatinine \> 20mg/dL or anuria, kidney failure or dialysis)
  • Subject with a history of transient ischemic attack(TIA), myocardial infarction(MI), unstable angina, cerebral infarction, cerebral hemorrhage, percutaneous transluminal angioplasty(PTA) or coronary artery bypass graft(CABG) within the last 6 months prior to the screening
  • Subject with severe heart failure(NYHA class III\~IV), arrythmia requiring treatment
  • Subject with known hypersensitivity (anaphylaxis) to any component of the study drug
  • Subject who had received other immunoglobulin product within the last 3 months prior to the study entry
  • Subject who had received live parenteral vaccine (MMR, Cholera and Varicella) within the last 3 months prior to the study entry
  • Subject who had received estrogen or hormone alternative medicine
  • +5 more criteria

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

  • Seung-Gyu Lee, Ph.D

    Seoul Asan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 20, 2018

First Posted

May 8, 2018

Study Start

March 29, 2018

Primary Completion

March 31, 2022

Study Completion

September 30, 2022

Last Updated

January 30, 2020

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)