Clinical trials: sponsored by GC Biopharma Corp
Influenza
A Phase I/IIa Study of GC3110A (Quadrivalent Influenza Vaccine)
The purpose of this study is to determine whether GC3110A (a QIV) is effective compared to GC Flu Pre-filled Syringe Inj. (a marketed TIV) after single intramuscular administration in Korean healthy adults.
- Trial name
- NCT02121782
- Testing
- Quadrivalent influenza vaccine, Trivalent influenza vaccine
- Where
- South Korea
- Volunteers
- 84 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
Hemophilia A
Safety, Efficacy and Pharmacokinetics of GreenGene™ F to Previously Treated Patients With Severe Hemophilia A
The purpose of this study is to assess the safety, efficacy and pharmacokinetics of GreenGene™ F in subjects with severe hemophilia A previously treated (> 150 exposure days) with a Factor VIII concentrate and without presence or…
- Trial name
- NCT01619046
- Testing
- GreenGene™ F and an approved recombinant Factor VIII product, GreenGene™ F
- Where
- 34 sites in United States, Canada and 5 more
- Volunteers
- 124 people
- Sponsor
- Green Cross Corporation
Hunter Syndrome
The Long-term Safety Study of Idursulfase-beta in Hunter Syndrome(Mucopolysaccharidosis II) Patients
The objective of this study is to evaluate the long term safety and efficacy of once weekly dosing of idurasulfase-beta 0.5mg/kg administered in Hunter Syndrome(Mucopolysaccharidosis II) Patients
- Trial name
- NCT02044692
- Where
- South Korea
- Volunteers
- 34 people
- Sponsor
- Green Cross Corporation
Thyroid Disease
Study for Hyalobarrier to Evaluate Anti-adhesive Effect and Safety Compared to Guardix-SG After Thyroidectomy
This study is a randomized, double-blind, active controlled phase 3 trial in the patients with thyroid disease, who will undergo total thyroidectomy (excluding the patients with the patient with the past history of thyroid…
- Trial name
- NCT01696305
- Testing
- Hyalobarrier, Guardix-SG
- Where
- 3 sites in South Korea
- Volunteers
- 198 people
- Sponsor
- Green Cross Corporation
Prevention of Influenza
Demonstrate the Lot-to-lot Consistency of 3 Consecutive Batches and to Evaluate the Efficacy and Safety of GC FLU®Pre-filled Syringe Injection and 'GC FLU®Injection' Administration.
This study is aimed to confirm the lot-to-lot consistency of 3 consecutive batches of 'GC FLU® Pre-filled Syringe Injection' and 'GC FLU® Injection' in the lot-to-lot
- Trial name
- NCT02067117
- Testing
- GC FLU® Injection, GC FLU® Pre-filled Syringe Injection
- Volunteers
- 1,139 people, healthy volunteers welcome
- Sponsor
- Green Cross Corporation
Immunologic Deficiency Syndrome
Phase 3 Study of Immune Globulin Intravenous (Human)IVIG-SN™ in Subjects With Primary Immunodeficiency
The purpose of this study is to evaluate the safety, efficacy and pharmacokinetics of Immune Globulin Intravenous (Human) IVIG-SN™ in subjects with primary immunodeficiency diseases.
- Trial name
- NCT01406470
- Testing
- Immune Globulin Intravenous (Human) 5% Liquid, IVIG-SN™
- Where
- 11 sites in United States, Canada
- Volunteers
- 45 people
- Sponsor
- Green Cross Corporation
Hemophilia A
Safety and Efficacy Extension Study of GreenGene™ F in Previously Treated Patients Diagnosed With Severe Hemophilia A
This study primarily will address the safety and secondarily will assess efficacy of GreenGene™ F in subjects with severe hemophilia A previously treated ≥50 exposure days with a GreenGene™ F, and without presence inhibitor to…
- Trial name
- NCT02027779
- Testing
- GreenGene™ F
- Where
- 2 sites in United States
- Volunteers
- 150 people
- Sponsor
- Green Cross Corporation
Hepatitis B
Safety and Pharmacokinetics Study of Healthy Male Adults When Repeatedly Administered Through Intravenous Injection
The purpose of this study is to evaluate the safety and pharmacokinetics of healthy male adults when subjects are repeatedly administered GC1102 (Hepabig_Gene) through intravenous injection.
- Trial name
- NCT01606163
- Testing
- GC1102, JW normal saline
- Where
- South Korea
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Green Cross Corporation
Osteoarthritis
To Evaluate the Safety of 'Shinbaro Capsule'in Patients With Osteoarthritis
This study investigates if Shinbaro capsule has a lower incident of gastrointestinal events than celecoxib in subjects with osteoarthritis.
- Trial name
- NCT01604239
- Testing
- Shinbaro Capsule
- Where
- 18 sites in South Korea
- Volunteers
- 761 people
- Sponsor
- Green Cross Corporation
Chemotherapy Induced Neutropenia
GCPGC in Chemotherapy-induced Neutropenia
This study is adaptive design and it consists of stage I and stage II. Stage I is multi-center, parallel-group, single-blind, phase II study to determine the adequate dose of GCPGC in chemotherapy-induced neutropenia.
- Trial name
- NCT01328938
- Testing
- GCPGC 3.6mg, GCPGC 6mg, Neulasta (pegfilgrastim) 6mg
- Where
- 15 sites in South Korea
- Volunteers
- 177 people
- Sponsor
- Green Cross Corporation
Malignant Lymphomas, Solid Tumors
Allogeneic Natural Killer (NK) Cell Therapy in Patients With Lymphoma or Solid Tumor
Allogeneic natural killer (NK) cells (MG4101) were manufactured from normal healthy donor who underwent leukapheresis. These cells were processed based on a novel method for ex vivo activation and expansion using an irradiated…
- Trial name
- MG4101 (NCT01212341)
- Testing
- Allogeneic NK cells
- Where
- South Korea
- Volunteers
- 18 people
- Sponsor
- Seoul National University Hospital
Severe Sepsis, Septic Shock
GCIV as an Adjuvant Therapy for Community-Acquired Severe Sepsis or Septic Shock
This study is to determine whether the intravenous application of 'Ⅳ-Globulin S inj. (Human Immunoglobulin G)' can reduce mortality in patients with severe sepsis or septic shock.
- Trial name
- NCT01315496
- Testing
- Immunoglobulin G
- Where
- 17 sites in South Korea
- Volunteers
- 214 people
- Sponsor
- Green Cross Corporation
Kawasaki Disease
Study of Combined Therapy of Aspirin and "IVIG-SN" in Kawasaki Disease
The purpose of this study is to evaluate the safety, efficacy and of Immune Globulin Intravenous (Human) IVIG-SN™ in subjects with kawasaki diseases.
- Trial name
- NCT01524939
- Testing
- immunoglobulin G
- Where
- 7 sites in South Korea
- Volunteers
- 45 people
- Sponsor
- Green Cross Corporation
Healthy Male
A Study to Assess Safety, Tolerability, and Pharmacokinetics of Orally Administered GCC4401C in Healthy Volunteers
The purpose of this study is to evaluate the safety, tolerability and characterize the PK, PD f\profile.
- Trial name
- NCT01651234
- Testing
- GCC-4401, GCC-4401C
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Green Cross Corporation
Healthy Volunteer
To Evaluate the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of Erythropoietin
This is a Dose-Block Randomized, Double-blind Placebo controlled, Open-label Active controlled, Dose-escalation Study to investigate the safety, tolerability, and Pharmacokinetics/Pharmacodynamics of GC1113 after Single…
- Trial name
- NCT01363934
- Testing
- GC1113, Darbepoetin alfa
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Green Cross Corporation
Hemophilia A
Efficacy and Safety of Recombinant Factor VIII (GreenGene) in Patients With Hemophilia A
The purpose of this study is to study the evaluation of efficacy and safety of GreenGene (Recombinant Factor VIII).
- Trial name
- NCT01568580
- Testing
- GreenGene
- Volunteers
- 71 people
- Sponsor
- Green Cross Corporation
Osteoarthritis
Efficacy and Safety of Shinbaro Capsule
The purpose of this study is to evaluate the efficacy and safety of 'Shinbaro Capsule', a new herbal anti-arthritic agent, in patients with osteoarthritis of the knee.
- Trial name
- NCT01535417
- Testing
- Shinbaro Capsule, Celebrex
- Volunteers
- 198 people
- Sponsor
- Green Cross Corporation
Mucopolysaccharidosis II
To Evaluate the Safety and Efficacy of GC1111 (Recombinant Human Iduronate-2-sulfatase) in Hunter Syndrome Patients
The purpose of this study is to evaluate the safety and efficacy of GC1111 (recombinant human iduronate-w-sulfatase) in Hunter Syndrome (Mucopolysaccharidosis II) patients
- Trial name
- NCT01301898
- Testing
- GC1111_0.5mg/kg, GC1111_1.0mg/kg, Elaprase_0.5mg/kg
- Where
- South Korea
- Volunteers
- 31 people
- Sponsor
- Green Cross Corporation
Influenza Infection
A Study to Evaluate the Safety and Immunogenicity of an Inactivated Split-virion Influenza A(H1N1) Vaccine
The purpose of this study is to assess the safety and the body's immune response to an experimental H1N1 influenza vaccine in healthy adult and elderly populations.
- Trial name
- NCT01201902
- Testing
- Adjuvanted influenza A(H1N1) vaccine, un-adjuvanted influenza A(H1N1) vaccine
- Volunteers
- 592 people, healthy volunteers welcome
- Sponsor
- Green Cross Corporation