A multi-center, randomized, double blind, placebo control, parallel design, phase 2a trial to evaluate the efficacy and safety of PGA

A multi-center, randomized, double blind, placebo control, parallel design, phase 2a trial to evaluate the efficacy and safety of PGA (Poly-gamma-glutamic Acid) for the fertile women with Cervical Intraepithelial Neoplasia(CIN I)

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0000733

Enrollment

200

Registered

2013-04-26

Start date

2013-04-23

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : 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 (

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1.Fertile women between age of 20 and 40 2.Patients with cervical intraepithelial neoplasia 1(CIN1) 3.HPV(Human Papilloma Virus) positive(+) 4.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 5.AST(Aspartate Aminotransferase) no less than 4 times higher than normal ALT(Alanine Aminotransferase) no less than 4 times higher than normal 6.Normal for EKG(Electrocardiography) and no active disease detected trough chest X-ray 7.Be informed of the nature of the study and will give written informed consent

Exclusion criteria

Exclusion criteria: 1.Malignant tumor in any organ other than cervical intraepithelial neoplasia 2.Active liver disease, immune disorder and severe renal failure 3.Leukemia, collagenosis, sclerosis, autoimmune disease, clinically significant allergic disease(mild allergic symptom not required medicine excluded) 4.Diagnosed diabetes 5.Taking any of followings affecting immunological reaction within 7 days (Glucocorticoid, vitamins, health food and oriental medicine etc) 6.History of HPV(Human Papilloma Virus) vaccination 7.Pregnancy and breastfeeding 8.Registered in other clinical trials 9.Patients whom the investigator considers inappropriate to participate in the study

Design outcomes

Primary

Measure	Time frame
colposcopic with biopsy	—

Secondary

Measure	Time frame
Pap Smear Test;Reid Colposcopic Index;HPV DNA Chip Test;HPV HC ? assay;NK cell activity;MHC class II	—

Countries

Korea, Republic of

Contacts

Public ContactEunYoung Ki

The Catholic University of Korea, Seoul St. Mary's Hospital

Outcome results