Clinical trial NCT01826045: Efficacy and Safety Study of PGA (Poly-gamma Glutamic Acid) for Cervical Intraepithelial Neoplasia
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cervical Intraepithelial Neoplasia
Keywords: Treatment of Cervical Intraepithelial Neoplasia(CIN1)
Lead sponsor: BioLeaders Corporation
Sponsor class: INDUSTRY
First posted: 2013-04-08
Enrollment: 200
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Regression rate
timeFrame: up to 12 weeks
Secondary outcomes:
measure: Reid Colposcopic Index
timeFrame: up to 12 weeks
measure: Pap smear test
timeFrame: up to 12 weeks
measure: HPV (Human Papilloma Virus) DNA Test
timeFrame: up to 12 weeks
measure: HPV (Human Papilloma Virus) Hybrid CaptureII Test
timeFrame: up to 12 weeks
measure: NK (Natural Killer) Cell Activity
timeFrame: up to 12 weeks
measure: Peripheral Blood Mononuclear Cells (PBMCs)Test
timeFrame: up to 12 weeks
Other outcomes:
measure: Adverse Events
timeFrame: up to 12 weeks
measure: Vital Signs
timeFrame: up to 12 weeks
measure: Laboratory Tests
timeFrame: up to 12 weeks
Locations:
city: Daegu
country: Korea, Republic of
facility: The Dongsan Medical Center of Keimyung Hospital
city: Seoul
country: Korea, Republic of
facility: Kwandong University College of Medicine Cheil Hospital
city: Seoul
country: Korea, Republic of
facility: CHA Gangnam Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University, Korea Seoul St Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: MiZMedi Hospital
Study officials:
affiliation: Korea University Guro Hospital
name: Jae-Kwan Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kwandong University College of Medicine Cheil Hospital
name: Tae Jin Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Catholic University, Korea Seoul St Mary's Hospital
name: Jong Sup Park, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Dongsan Medical Center of Keimyung University
name: Chi-Heum Cho, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHA University
name: Seok Ju Seong, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: MizMedi Hospital
name: Yongsoo Park, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.