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

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ClinicalTrials.gov Identifier: NCT02569372
Recruitment Status : Completed
First Posted : October 6, 2015
Last Update Posted : October 16, 2017
Sponsor:
Information provided by (Responsible Party):
Green Cross Corporation

Brief Summary:
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 or disease Intervention/treatment Phase
Chronic Hepatitis B Biological: GC1102 Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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)
Actual Study Start Date : November 9, 2015
Actual Primary Completion Date : October 12, 2017
Actual Study Completion Date : October 12, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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)




Primary Outcome Measures :
  1. Dose Limiting Toxicity after the administration of GC1102 [ Time Frame: Part A: 4weeks, Part B: 7 weeks ]
  2. Adverse events after the administration of GC1102 [ Time Frame: Part A: 4weeks, Part B: 7 weeks ]
  3. Clinical findings in physical examination, vital signs and clinical laboratory after the administration of GC1102 [ Time Frame: Part A: 4weeks, Part B: 7 weeks ]

Secondary Outcome Measures :
  1. 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 ]
  2. Geometric mean titer of serum HBsAg at each measurement point after the administration of GC1102 [ Time Frame: Part A: 4weeks, Part B: 7 weeks ]
  3. 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 ]
  4. Occurrence rate of anti-GC1102 antibody [ Time Frame: Part A: 4weeks, Part B: 7 weeks ]
  5. Occurrence rate of HBV DNA sequence changes after the administration of GC1102 [ Time Frame: Part A: 4weeks, Part B: 7 weeks ]

Other Outcome Measures:
  1. Ctrough for Part B [ Time Frame: 7 weeks ]
  2. Terminal elimination half-life (t½β) [ Time Frame: Part A: 4weeks, Part B: 7 weeks ]
  3. Area under the time concentration curve from 0 to last and infinity (AUClast, AUC0-∞) [ Time Frame: Part A: 4weeks, Part B: 7 weeks ]
  4. Maximum plasma concentration(Cmax) [ Time Frame: Part A: 4weeks, Part B: 7 weeks ]
  5. Time to maximum plasma concentration (Tmax) [ Time Frame: Part A: 4weeks, Part B: 7 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02569372


Locations
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Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Green Cross Corporation
Investigators
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Principal Investigator: Sang-Hoon An, M.D. Severance Hospital
Study Director: Chin Kim Green Cross Corporation

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Responsible Party: Green Cross Corporation
ClinicalTrials.gov Identifier: NCT02569372     History of Changes
Other Study ID Numbers: GC1102B_P1
First Posted: October 6, 2015    Key Record Dates
Last Update Posted: October 16, 2017
Last Verified: October 2017

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