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

Phase 2

Completed

• Conditions: Cervical Intraepithelial Neoplasia
• Interventions: Drug: Placebo; Drug: Poly-gamma Glutamic Acid

• Registration Number: NCT01826045
• Lead Sponsor: BioLeaders Corporation

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

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

Study Timeline

• Study First Submitted: 2013-03-29
• Study First Submitted QC: 2013-04-05
• Study First Posted: 2013-04-08
• Study Start: 2013-06
• Primary Completion: 2015-12
• Status Verified: 2016-01
• Study Completion: 2016-01
• Last Update Submitted: 2016-01-28
• Last Update Posted: 2016-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Regression rate	up to 12 weeks	Regression rate will be assessed at the time of screening and 12 weeks. Regression means the change from the stage of CIN1 to normal.

Secondary Outcome Measures

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

Trial Locations

Locations (6)

The Dongsan Medical Center of Keimyung Hospital; 🇰🇷 Daegu, Korea, Republic of

Kwandong University College of Medicine Cheil Hospital; 🇰🇷 Seoul, Korea, Republic of

The Catholic University, Korea Seoul St Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of

Korea University Guro Hospital; 🇰🇷 Seoul, Korea, Republic of

MiZMedi Hospital; 🇰🇷 Seoul, Korea, Republic of

CHA Gangnam Hospital; 🇰🇷 Seoul, Korea, Republic of