Evaluate the Safety and Exploratory Efficacy of GC1119

Green Cross Corporation

Status and phase

Completed

Phase 1

Conditions

Fabry Disease

Treatments

Drug: GC1119

Study type

Interventional

Funder types

Industry

Identifiers

NCT01653444

GC1119_P1

Details and patient eligibility

About

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.

Enrollment

8 patients

Sex

Male

Ages

16+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subjects with a current diagnosis of Fabry's disease
Plasma α-gal activity of ≤ 1.5mnol/hr/ml and have a mutation in α-galactosidase A gene
Males ≥ 16 years old
Subjects capable of performing this clinical trial in an appropriate manner
Informed consent form voluntarily signed by the subject(or his legally acceptable representative if the subject is under 20 years old) to participation in the study
Agreement to contraception during the study period

Exclusion criteria

Serum creatinine > 2.5mg/dl
Subjects have a plan to kidney transplantation
Subjects have undergone kidney transplantation
Subjects are currently on dialysis
Subjects have a clinically significant organic disease(cardiovascular, hepatic, pulmonary, neurologic, or renal disease)that in the opinion of the investigator would preclude participation in the trial
Known life-threatening hypersensitivity(anaphylactic reaction) to α-galactosidase
Treatment with another investigational product within 30days from the administration of study drug dosing or plans to be treated with another investigational product during the study period
Known hypersensitivity to any of the ingredients of study drug(including excipients)
Subjects need the medication of prohibited drug
Alcoholism or drug addiction