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

Primary Purpose

Cervical Intraepithelial Neoplasia

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Poly-gamma Glutamic Acid
Placebo
Sponsored by
BioLeaders Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Intraepithelial Neoplasia focused on measuring Treatment of Cervical Intraepithelial Neoplasia(CIN1)

Eligibility Criteria

20 Years - 49 Years (Adult)FemaleDoes not accept 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

Sites / Locations

  • The Dongsan Medical Center of Keimyung Hospital
  • Kwandong University College of Medicine Cheil Hospital
  • CHA Gangnam Hospital
  • The Catholic University, Korea Seoul St Mary's Hospital
  • Korea University Guro Hospital
  • MiZMedi Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Poly-gamma Glutamic Acid

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Reid Colposcopic Index
Reid Colposcopic Index will be assessed at the time of screening and 12 weeks.
Pap smear test
Result of Pap smear test will be assessed at the time of screening and 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.
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.
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.
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.

Full Information

First Posted
March 29, 2013
Last Updated
January 28, 2016
Sponsor
BioLeaders Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01826045
Brief Title
Efficacy and Safety Study of PGA (Poly-gamma Glutamic Acid) for Cervical Intraepithelial Neoplasia
Acronym
PGA
Official Title
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
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BioLeaders Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Intraepithelial Neoplasia
Keywords
Treatment of Cervical Intraepithelial Neoplasia(CIN1)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Poly-gamma Glutamic Acid
Arm Type
Experimental
Arm Description
Patients with cervical intraepithelial neoplasia 1(CIN1) will be administered Poly-gamma Glutamic Acid for 4 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients with cervical intraepithelial neoplasia 1(CIN1) will be administered placebo for 4 weeks.
Intervention Type
Drug
Intervention Name(s)
Poly-gamma Glutamic Acid
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Regression rate
Description
Regression rate will be assessed at the time of screening and 12 weeks. Regression means the change from the stage of CIN1 to normal.
Time Frame
up to 12 weeks
Secondary Outcome Measure Information:
Title
Reid Colposcopic Index
Description
Reid Colposcopic Index will be assessed at the time of screening and 12 weeks.
Time Frame
up to 12 weeks
Title
Pap smear test
Description
Result of Pap smear test will be assessed at the time of screening and 12 weeks.
Time Frame
up to 12 weeks
Title
HPV (Human Papilloma Virus) DNA Test
Description
Result of HPV (Human Papilloma Virus) DNA Test will be assessed at the time of screening and 12 weeks.
Time Frame
up to 12 weeks
Title
HPV (Human Papilloma Virus) Hybrid CaptureII Test
Description
Result of HPV (Human Papilloma Virus) Hybrid CaptureII Test will be assessed at the time of screening and 12 weeks.
Time Frame
up to 12 weeks
Title
NK (Natural Killer) Cell Activity
Description
Result of NK (Natural Killer) Cell Activity will be assessed at the time of baseline (0day), 4 weeks, 8 weeks and 12 weeks.
Time Frame
up to 12 weeks
Title
Peripheral Blood Mononuclear Cells (PBMCs)Test
Description
Result of Peripheral Blood Mononuclear Cells (PBMCs) Test will be assessed at the time of baseline (0day), 4 weeks, 8 weeks and 12 weeks.
Time Frame
up to 12 weeks
Other Pre-specified Outcome Measures:
Title
Adverse Events
Description
Adverse events will be monitored for 12 weeks.
Time Frame
up to 12 weeks
Title
Vital Signs
Description
Vital signs will be monitored for 12 weeks.
Time Frame
up to 12 weeks
Title
Laboratory Tests
Description
Result of laboratory tests will be assessed at screening.
Time Frame
up to 12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jae-Kwan Lee, MD, PhD
Organizational Affiliation
Korea University Guro Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tae Jin Kim, MD, PhD
Organizational Affiliation
Kwandong University College of Medicine Cheil Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jong Sup Park, MD, PhD
Organizational Affiliation
The Catholic University, Korea Seoul St Mary's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chi-Heum Cho, MD, PhD
Organizational Affiliation
The Dongsan Medical Center of Keimyung University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Seok Ju Seong, MD, PhD
Organizational Affiliation
CHA University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yongsoo Park, MD, PhD
Organizational Affiliation
MizMedi Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Dongsan Medical Center of Keimyung Hospital
City
Daegu
ZIP/Postal Code
700-712
Country
Korea, Republic of
Facility Name
Kwandong University College of Medicine Cheil Hospital
City
Seoul
ZIP/Postal Code
100-380
Country
Korea, Republic of
Facility Name
CHA Gangnam Hospital
City
Seoul
ZIP/Postal Code
135-913
Country
Korea, Republic of
Facility Name
The Catholic University, Korea Seoul St Mary's Hospital
City
Seoul
ZIP/Postal Code
137-701
Country
Korea, Republic of
Facility Name
Korea University Guro Hospital
City
Seoul
ZIP/Postal Code
152-703
Country
Korea, Republic of
Facility Name
MiZMedi Hospital
City
Seoul
ZIP/Postal Code
157-723
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
31220105
Citation
Cho HW, Park YC, Sung MH, Park JS, Kim TJ, Seong SJ, Cho CH, Lee JK. Short-term clinical and immunologic effects of poly-gamma-glutamic acid (gamma-PGA) in women with cervical intraepithelial neoplasia 1 (CIN 1): A multicenter, randomized, double blind, phase II trial. PLoS One. 2019 Jun 20;14(6):e0217745. doi: 10.1371/journal.pone.0217745. eCollection 2019.
Results Reference
derived

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

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