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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01826045
Recruitment Status : Completed
First Posted : April 8, 2013
Last Update Posted : January 29, 2016
Sponsor:
Information provided by (Responsible Party):
BioLeaders Corporation

Study Description
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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).

Condition or disease Intervention/treatment Phase
Cervical Intraepithelial Neoplasia Drug: Poly-gamma Glutamic Acid Drug: Placebo Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : June 2013
Actual Primary Completion Date : December 2015
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine


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


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Reid Colposcopic Index [ Time Frame: up to 12 weeks ]
    Reid Colposcopic Index will be assessed at the time of screening and 12 weeks.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.


Other Outcome Measures:
  1. Adverse Events [ Time Frame: up to 12 weeks ]
    Adverse events will be monitored for 12 weeks.

  2. Vital Signs [ Time Frame: up to 12 weeks ]
    Vital signs will be monitored for 12 weeks.

  3. Laboratory Tests [ Time Frame: up to 12 weeks ]
    Result of laboratory tests will be assessed at screening.


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01826045


Locations
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Korea, Republic of
The Dongsan Medical Center of Keimyung Hospital
Daegu, Korea, Republic of, 700-712
Kwandong University College of Medicine Cheil Hospital
Seoul, Korea, Republic of, 100-380
CHA Gangnam Hospital
Seoul, Korea, Republic of, 135-913
The Catholic University, Korea Seoul St Mary's Hospital
Seoul, Korea, Republic of, 137-701
Korea University Guro Hospital
Seoul, Korea, Republic of, 152-703
MiZMedi Hospital
Seoul, Korea, Republic of, 157-723
Sponsors and Collaborators
BioLeaders Corporation
Investigators
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Principal Investigator: Jae-Kwan Lee, MD, PhD Korea University Guro Hospital
Principal Investigator: Tae Jin Kim, MD, PhD Kwandong University College of Medicine Cheil Hospital
Principal Investigator: Jong Sup Park, MD, PhD The Catholic University, Korea Seoul St Mary's Hospital
Principal Investigator: Chi-Heum Cho, MD, PhD The Dongsan Medical Center of Keimyung University
Principal Investigator: Seok Ju Seong, MD, PhD CHA University
Principal Investigator: Yongsoo Park, MD, PhD MizMedi Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: BioLeaders Corporation
ClinicalTrials.gov Identifier: NCT01826045    
Other Study ID Numbers: UMT2012-BL-PGA-01
12335 ( Other Identifier: Korea Food and Drug Administration )
First Posted: April 8, 2013    Key Record Dates
Last Update Posted: January 29, 2016
Last Verified: January 2016
Keywords provided by BioLeaders Corporation:
Treatment of Cervical Intraepithelial Neoplasia(CIN1)
Additional relevant MeSH terms:
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Neoplasms
Carcinoma in Situ
Cervical Intraepithelial Neoplasia
 Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type