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

January 28, 2016 updated by: BioLeaders Corporation

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)

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).

Study Overview

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 Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Daegu, Korea, Republic of, 700-712
        • The Dongsan Medical Center of Keimyung Hospital
      • Seoul, Korea, Republic of, 152-703
        • Korea University Guro Hospital
      • Seoul, Korea, Republic of, 100-380
        • Kwandong University College of Medicine Cheil Hospital
      • Seoul, Korea, Republic of, 137-701
        • The Catholic University, Korea Seoul St Mary's Hospital
      • Seoul, Korea, Republic of, 135-913
        • CHA Gangnam Hospital
      • Seoul, Korea, Republic of, 157-723
        • MiZMedi Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 49 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reid Colposcopic Index
Time Frame: up to 12 weeks
Reid Colposcopic Index will be assessed at the time of screening and 12 weeks.
up to 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.
up to 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.
up to 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.
up to 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.
up to 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.
up to 12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: up to 12 weeks
Adverse events will be monitored for 12 weeks.
up to 12 weeks
Vital Signs
Time Frame: up to 12 weeks
Vital signs will be monitored for 12 weeks.
up to 12 weeks
Laboratory Tests
Time Frame: up to 12 weeks
Result of laboratory tests will be assessed at screening.
up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Seok Ju Seong, MD, PhD, CHA University
  • Principal Investigator: Yongsoo Park, MD, PhD, MiZMedi Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (ACTUAL)

December 1, 2015

Study Completion (ACTUAL)

January 1, 2016

Study Registration Dates

First Submitted

March 29, 2013

First Submitted That Met QC Criteria

April 5, 2013

First Posted (ESTIMATE)

April 8, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

January 29, 2016

Last Update Submitted That Met QC Criteria

January 28, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • UMT2012-BL-PGA-01
  • 12335 (OTHER: Korea Food and Drug Administration)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cervical Intraepithelial Neoplasia

Clinical Trials on Placebo

3
Subscribe