Status:
COMPLETED
Efficacy and Safety Study of PGA (Poly-gamma Glutamic Acid) for Cervical Intraepithelial Neoplasia
Lead Sponsor:
BioLeaders Corporation
Conditions:
Cervical Intraepithelial Neoplasia
Eligibility:
FEMALE
20-49 years
Phase:
PHASE2
Brief 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).
Detailed Description
This study is to compare the regression rate of Cervical Intraepithelial Neoplasia (CIN1) between the treatment group and the control group. The treatment group will be administered with PGA (Poly-ga...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT01826045
Start Date
June 1 2013
End Date
January 1 2016
Last Update
January 29 2016
Active Locations (7)
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1
Korea University Guro Hospital
Seoul, Seoul, South Korea, 152-703
2
The Dongsan Medical Center of Keimyung Hospital
Daegu, South Korea, 700-712
3
Kwandong University College of Medicine Cheil Hospital
Seoul, South Korea, 100-380
4
CHA Gangnam Hospital
Seoul, South Korea, 135-913