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

Overview

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 Title of Study: “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)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 2015

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.

Interventions

  • Drug: Poly-gamma Glutamic Acid
  • Drug: Placebo

Arms, Groups and Cohorts

  • Experimental: Poly-gamma Glutamic Acid
    • Patients with cervical intraepithelial neoplasia 1(CIN1) will be administered Poly-gamma Glutamic Acid for 4 weeks.
  • Placebo Comparator: Placebo
    • Patients with cervical intraepithelial neoplasia 1(CIN1) will be administered placebo for 4 weeks.

Clinical Trial Outcome Measures

Primary Measures

  • Regression rate
    • Time Frame: 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 Measures

  • Reid Colposcopic Index
    • Time Frame: up to 12 weeks
    • Reid Colposcopic Index will be assessed at the time of screening and 12 weeks.
  • Pap smear test
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: up to 12 weeks
    • Result of HPV (Human Papilloma Virus) Hybrid CaptureII Test will be assessed at the time of screening and 12 weeks.
  • NK (Natural Killer) Cell Activity
    • Time Frame: 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
    • Time Frame: 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.

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 20 Years

Maximum Age: 49 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • BioLeaders Corporation
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jae-Kwan Lee, MD, PhD, Principal Investigator, Korea University Guro Hospital
    • Tae Jin Kim, MD, PhD, Principal Investigator, Kwandong University College of Medicine Cheil Hospital
    • Jong Sup Park, MD, PhD, Principal Investigator, The Catholic University, Korea Seoul St Mary’s Hospital
    • Chi-Heum Cho, MD, PhD, Principal Investigator, The Dongsan Medical Center of Keimyung University
    • Seok Ju Seong, MD, PhD, Principal Investigator, CHA University
    • Yongsoo Park, MD, PhD, Principal Investigator, MizMedi Hospital

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