Efficacy and Safety Study of PGA (Poly-gamma Glutamic Acid) for Cervical Intraepithelial Neoplasia

• Status: Completed
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to determine the efficacy and the safety of PGA(Poly-gamma Glutamic Acid) for the the fertile women with Cervical Intraepithelial Neoplasia (CIN1).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: BioLeaders Corporation

Criteria

Inclusion Criteria:

• Fertile women between age of 20 and 49

• Patients with cervical intraepithelial neoplasia 1(CIN1)

• HPV(Human Papilloma Virus) positive(+)

• White Blood Cell Count(WBC) over 4thous/ul, Hemoglobin above over 9.0g/dL Platelet over 150thous/uL and ANC(Absolute Neutrophil Count) over 1,500 10^6/L

• AST(Aspartate Aminotransferase) no less than 4 times higher than normal ALT(Alanine Aminotransferase) no less than 4 times higher than normal

• Normal for EKG(Electrocardiography) and no active disease detected trough chest X-ray

• Be informed of the nature of the study and will give written informed consent

Exclusion Criteria:

• Malignant tumor in any organ other than cervical intraepithelial neoplasia

• Active liver disease, immune disorder and severe renal failure

• Leukemia, collagenosis, sclerosis, autoimmune disease, clinically significant allergic disease(mild allergic symptom not required medicine excluded)

• Diagnosed diabetes

• Taking any of followings affecting immunological reaction within 7 days (Glucocorticoid, vitamins, health food and oriental medicine etc)

• Pregnancy and breastfeeding

• Registered in other clinical trials

• Patients whom the investigator considers inappropriate to participate in the study