Efficacy and Safety Study of PGA (Poly-gamma Glutamic Acid) for Cervical Intraepithelial Neoplasia
NCT ID: NCT01826045
Last Updated: 2016-01-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
200 participants
INTERVENTIONAL
2013-06-30
2016-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Poly-gamma Glutamic Acid
Patients with cervical intraepithelial neoplasia 1(CIN1) will be administered Poly-gamma Glutamic Acid for 4 weeks.
Poly-gamma Glutamic Acid
Placebo
Patients with cervical intraepithelial neoplasia 1(CIN1) will be administered placebo for 4 weeks.
Placebo
Interventions
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Poly-gamma Glutamic Acid
Placebo
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
49 Years
FEMALE
No
Sponsors
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BioLeaders Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Jae-Kwan Lee, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Korea University Guro Hospital
Tae Jin Kim, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Kwandong University College of Medicine Cheil Hospital
Jong Sup Park, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
The Catholic University, Korea Seoul St Mary's Hospital
Chi-Heum Cho, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
The Dongsan Medical Center of Keimyung University
Seok Ju Seong, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
CHA University
Yongsoo Park, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
MizMedi Hospital
Locations
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Korea University Guro Hospital
Seoul, Seoul, South Korea
The Dongsan Medical Center of Keimyung Hospital
Daegu, , South Korea
Kwandong University College of Medicine Cheil Hospital
Seoul, , South Korea
CHA Gangnam Hospital
Seoul, , South Korea
The Catholic University, Korea Seoul St Mary's Hospital
Seoul, , South Korea
Korea University Guro Hospital
Seoul, , South Korea
MiZMedi Hospital
Seoul, , South Korea
Countries
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References
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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.
Other Identifiers
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12335
Identifier Type: OTHER
Identifier Source: secondary_id
UMT2012-BL-PGA-01
Identifier Type: -
Identifier Source: org_study_id
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