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

Study Overview
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Brief Summary
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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
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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-gamma Glutamic Acid) for 4 weeks followed by 8 weeks observation. The control group will be observed for 12 weeks without any comparator.

Official Title
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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 1 (CIN1)

Conditions
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Cervical Intraepithelial Neoplasia

Intervention / Treatment
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* Drug: Poly-gamma Glutamic Acid
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Poly-gamma Glutamic Acid<br>Patients with cervical intraepithelial neoplasia 1(CIN1) will be administered Poly-gamma Glutamic Acid for 4 weeks. | Drug: Poly-gamma Glutamic Acid<br> <br> |
| Placebo Comparator: Placebo<br>Patients with cervical intraepithelial neoplasia 1(CIN1) will be administered placebo for 4 weeks. | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Regression rate | Regression rate will be assessed at the time of screening and 12 weeks. Regression means the change from the stage of CIN1 to normal. | up to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reid Colposcopic Index | Reid Colposcopic Index will be assessed at the time of screening and 12 weeks. | up to 12 weeks | 
| Pap smear test | Result of Pap smear test will be assessed at the time of screening and 12 weeks. | up to 12 weeks | 
| HPV (Human Papilloma Virus) DNA Test | Result of HPV (Human Papilloma Virus) DNA Test will be assessed at the time of screening and 12 weeks. | up to 12 weeks | 
| HPV (Human Papilloma Virus) Hybrid CaptureII Test | Result of HPV (Human Papilloma Virus) Hybrid CaptureII Test will be assessed at the time of screening and 12 weeks. | up to 12 weeks | 
| NK (Natural Killer) Cell Activity | Result of NK (Natural Killer) Cell Activity will be assessed at the time of baseline (0day), 4 weeks, 8 weeks and 12 weeks. | up to 12 weeks | 
| Peripheral Blood Mononuclear Cells (PBMCs)Test | Result of Peripheral Blood Mononuclear Cells (PBMCs) Test will be assessed at the time of baseline (0day), 4 weeks, 8 weeks and 12 weeks. | up to 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Treatment of Cervical Intraepithelial Neoplasia(CIN1)