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Trial record 96 of 517 for:    hepatitis b | Open Studies

A Phase 1 Study of GC1102 (Recombinant Hepatitis B Immunoglobulin) in Chronic Hepatitis B Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2015 by Green Cross Corporation
Sponsor:
Information provided by (Responsible Party):
Green Cross Corporation
ClinicalTrials.gov Identifier:
NCT02569372
First received: October 5, 2015
Last updated: December 7, 2015
Last verified: October 2015
  Purpose
This study is SAD(Single Ascending Dose)/MAD(Multiple Ascending Dose) study to Explore the Tolerability, Safety and Pharmacokinetics/Pharmacodynamics of GC1102 (Recombinant Hepatitis B Human Immunoglobulin) in Chronic Hepatitis B Patients.

Condition Intervention Phase
Chronic Hepatitis B
Biological: GC1102
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Open-label, Dose-escalation, Single-center, Phase I Trial to Explore the Tolerability, Safety and Pharmacokinetics/Pharmacodynamics of GC1102 (Recombinant Hepatitis B Human Immunoglobulin)

Resource links provided by NLM:


Further study details as provided by Green Cross Corporation:

Primary Outcome Measures:
  • Dose Limiting Toxicity after the administration of GC1102 [ Time Frame: Part A: 4weeks, Part B: 7 weeks ] [ Designated as safety issue: Yes ]
  • Adverse events after the administration of GC1102 [ Time Frame: Part A: 4weeks, Part B: 7 weeks ] [ Designated as safety issue: Yes ]
  • Clinical findings in physical examination, vital signs and clinical laboratory after the administration of GC1102 [ Time Frame: Part A: 4weeks, Part B: 7 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • HBsAg sero-conversion rate from positive to negative after the administration of GC1102 till End of Study visit [ Time Frame: Part A: 4weeks, Part B: 7 weeks ] [ Designated as safety issue: No ]
  • Geometric mean titer of serum HBsAg at each measurement point after the administration of GC1102 [ Time Frame: Part A: 4weeks, Part B: 7 weeks ] [ Designated as safety issue: No ]
  • Geometric mean titer of serum HBV DNA of each measurement point after the administration of GC1102 [ Time Frame: Part A: 4weeks, Part B: 7 weeks ] [ Designated as safety issue: No ]
  • Occurrence rate of anti-GC1102 antibody [ Time Frame: Part A: 4weeks, Part B: 7 weeks ] [ Designated as safety issue: No ]
  • Occurrence rate of HBV DNA sequence changes after the administration of GC1102 [ Time Frame: Part A: 4weeks, Part B: 7 weeks ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Ctrough for Part B [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]
  • Terminal elimination half-life (t½β) [ Time Frame: Part A: 4weeks, Part B: 7 weeks ] [ Designated as safety issue: No ]
  • Area under the time concentration curve from 0 to last and infinity (AUClast, AUC0-∞) [ Time Frame: Part A: 4weeks, Part B: 7 weeks ] [ Designated as safety issue: No ]
  • Maximum plasma concentration(Cmax) [ Time Frame: Part A: 4weeks, Part B: 7 weeks ] [ Designated as safety issue: No ]
  • Time to maximum plasma concentration (Tmax) [ Time Frame: Part A: 4weeks, Part B: 7 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 48
Study Start Date: October 2015
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GC1102 80,000 IU(Single does)
GC1102 80,000 IU(Single does) I.V.
Biological: GC1102
GC1102(Recombinant Hepatitis B Human Immunoglobulin)
Experimental: GC1102 120,000 IU(Single does)
GC1102 120,000 IU(Single does) I.V.
Biological: GC1102
GC1102(Recombinant Hepatitis B Human Immunoglobulin)
Experimental: GC1102 180,000 IU(Single does)
GC1102 180,000 IU(Single does) I.V.
Biological: GC1102
GC1102(Recombinant Hepatitis B Human Immunoglobulin)
Experimental: GC1102 240,000 IU(Single does)
GC1102 240,000 IU(Single does) I.V.
Biological: GC1102
GC1102(Recombinant Hepatitis B Human Immunoglobulin)
Experimental: GC1102 80,000 IU(Multiple does)
GC1102 80,000 IU(Multiple does) I.V.
Biological: GC1102
GC1102(Recombinant Hepatitis B Human Immunoglobulin)
Experimental: GC1102 120,000 IU(Multiple does)
GC1102 120,000 IU(Multiple does) I.V.
Biological: GC1102
GC1102(Recombinant Hepatitis B Human Immunoglobulin)
Experimental: GC1102 180,000 IU(Multiple does)
GC1102 180,000 IU(Multiple does) I.V.
Biological: GC1102
GC1102(Recombinant Hepatitis B Human Immunoglobulin)
Experimental: GC1102 240,000 IU(Multiple does)
GC1102 240,000 IU(Multiple does) I.V.
Biological: GC1102
GC1102(Recombinant Hepatitis B Human Immunoglobulin)

Detailed Description:
GC1102 is a new recombinant hepatitis B human immunoglobulin. This study is composed with 2 Parts, Part A for SAD and Part B for MAD and total 4 dosing program which is escalated after confirming safety. Maximum 48 subjects will be participated in the study.
  Eligibility

Ages Eligible for Study:   19 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with chronic hepatitis B or those who diagnosed with chronic hepatitis B carrier who given written informed consent.
  • Patients aged ≥19 and ≤ 65 years
  • If Naïve for the Nucleos(t)ide analogs therapy, HBeAg (-), HBsAg 1,000 IU/mL or less and HBV DNA 2,000IU/mL or less Or If currently receiving Nucleos(t)ide analogs therapy, HBeAg (±), HBsAg 1,000 IU/mL or less and HBV DNA (-: limit of detection of 60 IU/mL or less).

Exclusion Criteria:

  • Patients who currently involved or has participated in any other clinical trial within 30 days.
  • Patients co-infected with HAV, HCV or HIV
  • Patients with history of malignant tumor within 5 years except basal cell carcinoma of skin, cervical intraepithelial neoplasia.
  • Patients who have active infection except chronic hepatitis infection.
  • Patients with liver disease who had complications such as gastroesophageal variceal, ascites and hepatic encephalopathy.
  • Having eGFR 59 mL/min/1.73m2 or less with MDRD Evaluation phase (moderate reduction in GFR or more )
  • Having blood or protein 1+ or more by the urine analysis with microscopic examination.
  • Patients who have a clinically significant kidney disease including glomerulonephritis, anuria, acute renal failure, dialysis and renal transplantation.
  • Patients with Vasculitis.
  • Having leukocytes <3.0 x109/L
  • Having Absolute Neutrophil Count<1.5x109/L
  • Having platelet <750,000/mm3 during screening
  • Having hemoglobin <10g/dL
  • Having positive sign of serum cryoglobulin level.
  • Having serum anti-nuclear antibody (ANA) 1:160 or more
  • Patients who showed positive sign of serum perinuclear anti-Neutrophil Cytoplasmic Antibodies (p-ANCA).
  • Patients who showed positive sign of serum cytoplasmic anti-Neutrophil Cytoplasmic Antibodies (c-ANCA).
  • Patients who had history or be suspected of immune disease
  • Patients who had experienced cardiovascular attack, myocardiac infarction, heart failure, PTCA or coronary artery bypass, angina, arrhythmia, any other clinically meaningful valvular heart disease, cerebral infarction or cerebral hemorrhage within 6 months.
  • Patients who had history of anaphylaxis against the main component or subcomponent of study drug.
  • Patients who had been administered live vaccine parentally (measles vaccine, parotitis vaccine, rubella vaccine, cholera combined vaccine, varicella vaccine) within 3 months prior to the dosing of study drug.
  • Patients who had been received an immunosuppressant, immunity-modifying drug including interferon agents, cytotoxic chemotherapy that can affect their immune system, or radiation therapy within 3 months prior to the dosing of study drug
  • Patients who had been treated with any other immunoglobulin within 3 months prior to the dosing of study drug
  • Patients who had been treated with systemic steroid Therapy(more than 20 mg/day of prednisolone or its equivalence administered every day for more than 14 days, or more than 700 mg of a cumulative dose during the same period of time) within 3 months prior to the dosing of study drug (topical administration such as topical ointments, eye drops, inhalants or intranasal use, intra-articular injection, or tendon injection is acceptable; alternative-day treatment is acceptable even though administered for more than 14 days)
  • Women who showed positive sign of pregnancy test before administered study drug.
  • Those who do not agree to use appropriate contraceptive methods (condom, diaphoretic, an intrauterine device, oral contraceptive hormones, or a vasectomy of male sex partner) during the clinical trials.
  • Those who had experienced bleeding more 400ml or a blood donation within 8 weeks prior to the dosing of study drug.
  • Those who had been abused alcohol or any other drug within 6 months.
  • Those who are judged disqualified to join clinical trials by investigator for other clinically significant medical or psychiatric condition.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02569372

Contacts
Contact: Jung-Woo Park 82-(0)31-260-1905 pjw0620@greencross.com
Contact: Sang-Mi Kang 82-(0)31-260-9571 sm6220@greencross.com

Locations
Korea, Republic of
Severance Hospital Recruiting
Seoul, Korea, Republic of
Principal Investigator: Sanghoon An, M.D.         
Sponsors and Collaborators
Green Cross Corporation
Investigators
Principal Investigator: Sang-Hoon An, M.D. Severance Hospital
Study Director: Chang-Hee Lee, M.D. Green Cross Corporation
  More Information

Responsible Party: Green Cross Corporation
ClinicalTrials.gov Identifier: NCT02569372     History of Changes
Other Study ID Numbers: GC1102B_P1 
Study First Received: October 5, 2015
Last Updated: December 7, 2015
Health Authority: Korea: Ministry of Food and Drug Safety

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Immunoglobulins
Antibodies
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 26, 2016