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Chronic Hepatitis BPhase 1NCT02569372

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

A Phase 1 study testing GC1102 in people with Chronic Hepatitis B, run by Green Cross Corporation at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 to 65 years
Conditions the study is for
Chronic Hepatitis B
What is being tested?
GC1102
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
53 participants
Where
1 siteSouth Korea
Study dates
9 Nov 2015to 12 Oct 2017
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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 )
Show all 29Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Severance Hospital

    Seoul

Other trials in South Korea

About this study

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)

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.

Read the 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.

Being tested
GC1102
Medical subject headings
Hepatitis B, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GC1102Biological

    GC1102(Recombinant Hepatitis B Human Immunoglobulin)

Study groups in NCT02569372
Study groupRoleWhat they receive
GC1102 80,000 IU(Single does)ExperimentalGC1102 80,000 IU(Single does) I.V.
Receives: Biological: GC1102
GC1102 120,000 IU(Single does)ExperimentalGC1102 120,000 IU(Single does) I.V.
Receives: Biological: GC1102
GC1102 180,000 IU(Single does)ExperimentalGC1102 180,000 IU(Single does) I.V.
Receives: Biological: GC1102
GC1102 240,000 IU(Single does)ExperimentalGC1102 240,000 IU(Single does) I.V.
Receives: Biological: GC1102
GC1102 80,000 IU(Multiple does)ExperimentalGC1102 80,000 IU(Multiple does) I.V.
Receives: Biological: GC1102
GC1102 120,000 IU(Multiple does)ExperimentalGC1102 120,000 IU(Multiple does) I.V.
Receives: Biological: GC1102
GC1102 180,000 IU(Multiple does)ExperimentalGC1102 180,000 IU(Multiple does) I.V.
Receives: Biological: GC1102
GC1102 240,000 IU(Multiple does)ExperimentalGC1102 240,000 IU(Multiple does) I.V.
Receives: Biological: GC1102

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose Limiting Toxicity after the administration of GC1102

    Measured: Part A: 4weeks, Part B: 7 weeks

  2. Adverse events after the administration of GC1102

    Measured: Part A: 4weeks, Part B: 7 weeks

  3. Clinical findings in physical examination, vital signs and clinical laboratory after the administration of GC1102

    Measured: Part A: 4weeks, Part B: 7 weeks

Secondary outcomes (5)

  1. HBsAg sero-conversion rate from positive to negative after the administration of GC1102 till End of Study visit

    Measured: Part A: 4weeks, Part B: 7 weeks

  2. Geometric mean titer of serum HBsAg at each measurement point after the administration of GC1102

    Measured: Part A: 4weeks, Part B: 7 weeks

  3. Geometric mean titer of serum HBV DNA of each measurement point after the administration of GC1102

    Measured: Part A: 4weeks, Part B: 7 weeks

  4. Occurrence rate of anti-GC1102 antibody

    Measured: Part A: 4weeks, Part B: 7 weeks

  5. Occurrence rate of HBV DNA sequence changes after the administration of GC1102

    Measured: Part A: 4weeks, Part B: 7 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Oct 2015 (estimated)
  2. Study start9 Nov 2015
  3. Primary completion12 Oct 2017
  4. Study completion12 Oct 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
53 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02569372
Sponsor's protocol ID
GC1102B_P1
Status last verified
Oct 2017
First submitted
5 Oct 2015
Last updated
16 Oct 2017
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GC1102 in people with Chronic Hepatitis B, run by Green Cross Corporation at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose Limiting Toxicity after the administration of GC1102 (time frame: Part A: 4weeks, Part B: 7 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02569372.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2017.

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