- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01826045
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
Status
Completed
Conditions
Intervention / Treatment
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
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Daegu, Korea, Republic of, 700-712
- The Dongsan Medical Center of Keimyung Hospital
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Seoul, Korea, Republic of, 152-703
- Korea University Guro Hospital
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Seoul, Korea, Republic of, 100-380
- Kwandong University College of Medicine Cheil Hospital
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Seoul, Korea, Republic of, 137-701
- The Catholic University, Korea Seoul St Mary's Hospital
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Seoul, Korea, Republic of, 135-913
- CHA Gangnam Hospital
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Seoul, Korea, Republic of, 157-723
- MiZMedi Hospital
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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.
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|
PLACEBO_COMPARATOR: Placebo
Patients with cervical intraepithelial neoplasia 1(CIN1) will be administered placebo for 4 weeks.
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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.
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up to 12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reid Colposcopic Index
Time Frame: up to 12 weeks
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Reid Colposcopic Index will be assessed at the time of screening and 12 weeks.
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up to 12 weeks
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Pap smear test
Time Frame: up to 12 weeks
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Result of Pap smear test will be assessed at the time of screening and 12 weeks.
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up to 12 weeks
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HPV (Human Papilloma Virus) DNA Test
Time Frame: up to 12 weeks
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Result of HPV (Human Papilloma Virus) DNA Test will be assessed at the time of screening and 12 weeks.
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up to 12 weeks
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HPV (Human Papilloma Virus) Hybrid CaptureII Test
Time Frame: up to 12 weeks
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Result of HPV (Human Papilloma Virus) Hybrid CaptureII Test will be assessed at the time of screening and 12 weeks.
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up to 12 weeks
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NK (Natural Killer) Cell Activity
Time Frame: up to 12 weeks
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Result of NK (Natural Killer) Cell Activity will be assessed at the time of baseline (0day), 4 weeks, 8 weeks and 12 weeks.
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up to 12 weeks
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Peripheral Blood Mononuclear Cells (PBMCs)Test
Time Frame: up to 12 weeks
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Result of Peripheral Blood Mononuclear Cells (PBMCs) Test will be assessed at the time of baseline (0day), 4 weeks, 8 weeks and 12 weeks.
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up to 12 weeks
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse Events
Time Frame: up to 12 weeks
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Adverse events will be monitored for 12 weeks.
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up to 12 weeks
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Vital Signs
Time Frame: up to 12 weeks
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Vital signs will be monitored for 12 weeks.
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up to 12 weeks
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Laboratory Tests
Time Frame: up to 12 weeks
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Result of laboratory tests will be assessed at screening.
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up to 12 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
Additional Relevant MeSH Terms
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
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Krankenhaus Barmherzige Schwestern LinzMedical University of ViennaCompletedCervical Intraepithelial Neoplasia Grade 1 | Cervical Intraepithelial Neoplasia Grade 2Austria
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