Chronic Hepatitis B Clinical Trial
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)
Verified date | October 2017 |
Source | Green Cross Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 53 |
Est. completion date | October 12, 2017 |
Est. primary completion date | October 12, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years to 65 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Severance Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Green Cross Corporation |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Ctrough for Part B | 7 weeks | ||
Other | Terminal elimination half-life (t½ß) | Part A: 4weeks, Part B: 7 weeks | ||
Other | Area under the time concentration curve from 0 to last and infinity (AUClast, AUC0-8) | Part A: 4weeks, Part B: 7 weeks | ||
Other | Maximum plasma concentration(Cmax) | Part A: 4weeks, Part B: 7 weeks | ||
Other | Time to maximum plasma concentration (Tmax) | Part A: 4weeks, Part B: 7 weeks | ||
Primary | Dose Limiting Toxicity after the administration of GC1102 | Part A: 4weeks, Part B: 7 weeks | ||
Primary | Adverse events after the administration of GC1102 | Part A: 4weeks, Part B: 7 weeks | ||
Primary | Clinical findings in physical examination, vital signs and clinical laboratory after the administration of GC1102 | Part A: 4weeks, Part B: 7 weeks | ||
Secondary | HBsAg sero-conversion rate from positive to negative after the administration of GC1102 till End of Study visit | Part A: 4weeks, Part B: 7 weeks | ||
Secondary | Geometric mean titer of serum HBsAg at each measurement point after the administration of GC1102 | Part A: 4weeks, Part B: 7 weeks | ||
Secondary | Geometric mean titer of serum HBV DNA of each measurement point after the administration of GC1102 | Part A: 4weeks, Part B: 7 weeks | ||
Secondary | Occurrence rate of anti-GC1102 antibody | Part A: 4weeks, Part B: 7 weeks | ||
Secondary | Occurrence rate of HBV DNA sequence changes after the administration of GC1102 | Part A: 4weeks, Part B: 7 weeks |
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