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

BioLeaders

Status and phase: Completed; Phase 2

Conditions: Cervical Intraepithelial Neoplasia

Treatments: Drug: Poly-gamma Glutamic Acid; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01826045

12335 (Other Identifier)

UMT2012-BL-PGA-01

Details and patient eligibility

About

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).

Full 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-gamma Glutamic Acid) for 4 weeks followed by 8 weeks observation.

The control group will be observed for 12 weeks without any comparator.

Enrollment: 200 patients

Sex: Female

Ages: 20 to 49 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups, including a placebo group

Poly-gamma Glutamic Acid

Experimental group

Description:

Patients with cervical intraepithelial neoplasia 1(CIN1) will be administered Poly-gamma Glutamic Acid for 4 weeks.

Treatment:

Drug: Poly-gamma Glutamic Acid

Placebo

Placebo Comparator group

Description:

Patients with cervical intraepithelial neoplasia 1(CIN1) will be administered placebo for 4 weeks.

Treatment:

Drug: Placebo