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)
20 Years
40 Years
Female
Cervical Intraepithelial Neoplasia
Trial Information
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)
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.
Inclusion Criteria:
- Fertile women between age of 20 and 40
- 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)
- History of HPV(Human Papilloma Virus) vaccination
- Pregnancy and breastfeeding
- Registered in other clinical trials
- Patients whom the investigator considers inappropriate to participate in the study
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Regression rate
Outcome 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.
Outcome Time Frame:
up to 12 weeks
Safety Issue:
No
Principal Investigator
Jae-Kwan Lee, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Korea University Guro Hospital
Authority:
Korea: Food and Drug Administration
Study ID:
UMT2012-BL-PGA-01
NCT ID:
NCT01826045
Start Date:
March 2013
Completion Date:
May 2015
Related Keywords:
- Cervical Intraepithelial Neoplasia
- Treatment of Cervical Intraepithelial Neoplasia(CIN1)
- Neoplasms
- Cervical Intraepithelial Neoplasia
- Carcinoma in Situ
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