A Phase 2 Study of GC1102 (Recombinant Hepatitis B Immuno... | NCT02304315

Studies
A Phase 2 Study of GC1102 (Recombinant Hepatitis B Immunoglobulin) in HBV-related Liver Transplant Recipients

NCT02304315

Sponsor

Green Cross Corporation

Status

Completed

Last Update Posted

Jun 30, 2016Estimated

Enrollment

40Actual

Phase

Phase 2

Conditions

Hepatitis B Infection

Interventions

GC1102 50,000 IU
GC1102 80,000 IU

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2015

Primary Completion Date

May 2016Actual

Completion Date

May 2016Actual

First Submitted Date

Nov 26, 2014

First Submission Date that Met QC Criteria

Nov 28, 2014

First Posted Date

Dec 1, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 29, 2016

Last Update Posted Date

Jun 30, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

GC1102 is a new recombinant hepatitis B immunoglobulin (HBIg) from Chinese Hamster Ovary (CHO) cells. It is a monoclonal antibody and has high affinity and avidity to hepatitis B surface antigen and several advantages compared to HBIg derived from blood plasma of human donors. Forty volunteers will participate in the study, receive 24-week treatment with low dose (50,000IU) of GC1102 or with high dose (80,000IU) and be followed up till 28 weeks.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
GC1102 50,000 IU	Biological	a recombinant hepatitis B immunoglobulin	GC1102 50,000 IU

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Recurrence rate of Hepatitis B	Seroconversion rate of HBsAg or HBeAg	28 weeks

Secondary Outcomes

Measure	Description	Time Frame
Seroconversion rate of HBsAg or HBeAg		28 weeks
Seroconversion time of HBsAg or HBeAg		28 weeks
Overall survival rate

Other Outcomes

Measure	Description	Time Frame
Adverse events		28 weeks
Clinical abnormalities in physical exam, vital signs, and/or laboratory		28 weeks
Infusion reactions

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Sung-Gyu Lee, M.D.	Seoul Asan Medical Center	Principal Investigator
Chang-Hee Lee, M.D.	GC Biopharma Corp	Study Director

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D018347	Hepadnaviridae Infections