Clinical trials: sponsored by GC Biopharma Corp
- Sponsor GC Biopharma Corp
- Funder type Industry (pharma, biotech, devices)
- Age group Children (under 18)
Sanfilippo Syndrome Type A
Phase 1 Study of GC1130A in Patients With Sanfilippo Syndrome Type A (MPS IIIA)
The purpose of this study is to evaluate the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of recombinant human heparan N-sulfatase (rhHNS, GC1130A) administered via intracerebroventricular access device…
- Trial name
- NCT06567769
- Testing
- GC1130A
- Where
- 4 sites in United States, South Korea
- Volunteers
- 9 people
- Sponsor
- GC Biopharma Corp
Varicella (Chickenpox), Chickenpox Vaccine
A Study to Evaluate Immunogenicity and Safety After the First and Second Doses of MG1111 (BARYCELA Inj.) in Healthy Children Aged 12 Months to 12 Years
This clinical study aims to evaluate the safety and immune response of MG1111, in healthy children compared to VARIVAX. The study will follow participants for 42 days after receiving two doses, with additional follow-ups for up…
- Trial name
- NCT07054099
- Testing
- MG1111 (Barycela inj.), VARIVAX™
- Where
- Thailand
- Volunteers
- 474 people, healthy volunteers welcome
- Sponsor
- GC Biopharma Corp
MPS II, Hunter Syndrome (MPS II)
An Extension Study to Assess the Long-term Safety and Efficacy of Hunterase (Idursulfase Beta)
The objective of this study is to assess the long-term safety and efficacy of Hunterase for approximately 1 year in subjects who completed the end of study (EOS) visit (Visit 54) tests in the Phase 3 Hunterase study and patients…
- Conditions
- MPS II, Hunter Syndrome (MPS II), Hunter Syndrome, Hunterase
- Trial name
- NCT07344376
- Testing
- Hunterase
- Where
- South Korea
- Volunteers
- 30 people
- Sponsor
- GC Biopharma Corp
Primary Immune Deficiency
Study of Immune Globulin Intravenous (Human) GC5107 in Pediatric Subjects With Primary Humoral Immunodeficiency
The purpose of this study is to evaluate the pharmacokinetics and safety of Immune Globulin Intravenous (Human) GC5107 in pediatric subjects with Primary Humoral Immunodeficiency (PHID).
- Trial name
- NCT04565015
- Testing
- GC5107
- Where
- 8 sites in United States, Bosnia and Herzegovina and 1 more
- Volunteers
- 24 people
- Sponsor
- GC Biopharma Corp
Mucopolysaccharidosis II, Hunter Syndrome
A Study to Evaluate the Safety, Tolerability, PK and PD of Intracerebroventricular GC1123 in Patients with MPS Ⅱ
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of intracerebroventricular GC1123 in patients with MPS Ⅱ who have central nervous system involvement and are receiving…
- Trial name
- NCT05422482
- Testing
- GC1123
- Where
- 3 sites in South Korea
- Volunteers
- 12 people
- Sponsor
- GC Biopharma Corp
Hunter Syndrome
A Study of GC1111 in Hunter Syndrom Patients
The objective of this study is to evaluate the efficacy of GC1111 in Hunter Syndrome Patients
- Trial name
- NCT03920540
- Testing
- GC1111, Comparator
- Where
- South Korea
- Volunteers
- 32 people
- Sponsor
- Green Cross Corporation
Varicella
Evaluate the Safety and Immunogenicity After MG1111(BARICELA Inj.) as 2nd Vaccination in 4 ~ 6 Year Old Healthy Children With a History of 1st Varicella Vaccination
Primary objective is to assess the safety of MG1111 until Day 42 using as 2nd vaccination Secondary objective to assess the immunogenicity and safety of MG1111 using as 2nd vaccination
- Trial name
- NCT05422508
- Testing
- MG1111 (BARICELA), VARIVAX, Suduvax
- Where
- South Korea
- Volunteers
- 230 people, healthy volunteers welcome
- Sponsor
- Green Cross Corporation
Varicella Zoster Virus Infection
An Open-label, Bridging Study of BARYCELA Inj. in Healthy Vietnamese Children Aged Between 12 Months to 12 Years
The goal of this bridging study is to assess the safety and immunogenicity of BARYCELA inj. in healthy Vietnamese children aged between 12 months to 12 years. The main questions it aims to answer are: Safety of BARYCELA inj.
- Trial name
- NCT05664152
- Testing
- MG1111
- Volunteers
- 250 people, healthy volunteers welcome
- Sponsor
- GC Biopharma Corp
Immunologic Deficiency Syndromes
Study of Immune Globulin Intravenous (Human) GC5107 in Subjects With Primary Humoral Immunodeficiency
The purpose of this study is to evaluate the safety, efficacy and Pharmacokinetics of Immune Globulin Intravenous (Human) GC5107 in subjects with Primary Humoral Immunodeficiency (PHID).
- Trial name
- NCT02783482
- Testing
- GC5107
- Where
- 20 sites in United States, Canada
- Volunteers
- 49 people
- Sponsor
- Green Cross Corporation
BCG Vaccination Reaction, Tuberculosis
A Study of GC3107(BCG Vaccine) in Healthy Infants
The purpose of this study is to investigate the efficacy and safety of GC3107 in healthy infants
- Trial name
- NCT03947138
- Testing
- GC3107, Intradermal BCG SSI inj.
- Where
- 2 sites in South Korea
- Volunteers
- 750 people, healthy volunteers welcome
- Sponsor
- Green Cross Corporation
Healthy Children
A Study of MG1111 in Healthy Children
To assess the safety of MG1111 and to evaluate immunological non-inferiority of MG1111 versus comparator
- Trial name
- NCT03375502
- Testing
- Varicella Vaccine
- Where
- South Korea
- Volunteers
- 814 people, healthy volunteers welcome
- Sponsor
- Green Cross Corporation
Primary Immune Deficiency Disorder
Study of Immune Globulin Intravenous (Human) GC5101F in Subjects With Primary Humoral Immunodeficiency
To assess the safety, efficacy, and pharmacokinetics of IGIV-SN in pediatric subjects with primary immunodeficiency humoral diseases (PHID)
- Trial name
- NCT03492710
- Testing
- Immunoglobulin
- Sponsor
- Green Cross Corporation
Autoimmune Encephalitis
Safety and Efficacy of IGIV 10% in Patients With Autoimmune Encephalitis:
The purpose of this study is to evaluate the safety and efficacy of IGIV 10% in patients with autoimmune encephalitis
- Trial name
- NCT04175522
- Testing
- Immunoglobulin G
- Where
- South Korea
- Volunteers
- 23 people
- Sponsor
- Green Cross Corporation
Kawasaki Disease
Study of Combined Therapy IVIG-SN 10% and Acetylsalicylic Acid in Kawasaki Disease
The purpose of this study is to evaluate the efficacy and safety of high-dose human Immunoglobulin G Intravenous (IGIV) 10% in subjects with Kawasaki diseases (KD).
- Trial name
- NCT04003844
- Testing
- Immunoglobulin G, Acetylsalicylic acid
- Where
- 7 sites in South Korea
- Volunteers
- 45 people
- Sponsor
- Green Cross Corporation
Influenza Vaccine
A Study to Evaluate the Efficacy and Safety of GC3110A in Healthy Infants From 6 Months to 35 Months of Age
If study subject's legal guardians who decide voluntarily to participate the clinical trial, and sign the Informed Consent Formed, study subjects eligible for participating this trial protocol were assigned to test group or…
- Trial name
- NCT03285997
- Testing
- GC3110A, GCFLU Pre-filled syringe inj.
- Where
- South Korea
- Volunteers
- 260 people, healthy volunteers welcome
- Sponsor
- Green Cross Corporation
Influenza
A Study to Evaluate the Efficacy and Safety of 'GC3110A(QIV)' in Healthy Children
1. Part 1 If study subject and legal guardians who decide voluntarily to participate the clinical trial, and sign the Informed Consent Form (In the case of study subject less than 7 years of age, written informed consent by study…
- Trial name
- NCT02541253
- Testing
- GC3110A, GCFLU Pre-filled Syringe inj.
- Where
- 12 sites in South Korea
- Volunteers
- 543 people, healthy volunteers welcome
- Sponsor
- Green Cross Corporation
Fabry Disease
Evaluate the Safety and Exploratory Efficacy of GC1119
The purpose of this study is to evaluate the safety and exploratory efficacy of GC1119 (recombinant human α-galactosidase A) for enzyme replacement therapy in Fabry disease patients.
- Trial name
- NCT01653444
- Testing
- GC1119
- Where
- 3 sites in South Korea
- Volunteers
- 8 people
- Sponsor
- Green Cross Corporation
Mucopolysaccharidosis II
Study of Idursulfase-beta (GC1111) in Hunter Syndrome
This study evaluates the efficacy and safety of three doses of GC1111 in patients with Hunter Syndrome. Participants will be randomized to one of three doses of GC1111 or comparator.
- Trial name
- NCT02663024
- Testing
- idursulfase beta, idursulfase
- Volunteers
- 20 people
- Sponsor
- Green Cross Corporation
Bacterial Infections
To Evaluate the Effectiveness(Immunogenicity) and Safety of 'GC1107' Administered Intramuscularly in Healthy Children
The purpose of this study is to evaluate the effectiveness(immunogenicity) and safety of 'GC1107' administered intramuscularly in healthy children
- Trial name
- NCT01402713
- Testing
- GC1107, TD_PUR INJ / SK Td vaccine
- Where
- South Korea
- Volunteers
- 311 people, healthy volunteers welcome
- Sponsor
- Green Cross Corporation
Hunter Syndrome
Safety and Efficacy of Hunterase
The objective of this study is to determine the safety and efficacy of once weekly dosing of idursulfase-beta 0.5mg/kg administered by intravenous(IV) infusion for Hunter syndrome patients < 6 years old.
- Trial name
- GC1111 (NCT01645189)
- Testing
- Hunterase
- Where
- South Korea
- Volunteers
- 6 people
- Sponsor
- Green Cross Corporation