KCT0000733Recruiting未知
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(CIN I)
Bioleaders0 sites200 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Recruiting
- Sponsor
- Enrollment
- 200
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional Study
Eligibility Criteria
- Ages
- 20(Year) to 40(Year) (—)
- Sex
- Female
Inclusion Criteria
- •1.Fertile women between age of 20 and 40
- •2.Patients with cervical intraepithelial neoplasia 1(CIN1)
- •3.HPV(Human Papilloma Virus) positive(+)
- •4.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
- •5.AST(Aspartate Aminotransferase) no less than 4 times higher than
- •normal ALT(Alanine Aminotransferase) no less than 4 times higher than
- •6.Normal for EKG(Electrocardiography) and no active disease detected
- •trough chest X-ray
- •7.Be informed of the nature of the study and will give written informed consent
Exclusion Criteria
- •1.Malignant tumor in any organ other than cervical intraepithelial
- •2.Active liver disease, immune disorder and severe renal failure
- •3.Leukemia, collagenosis, sclerosis, autoimmune disease, clinically
- •significant allergic disease(mild allergic symptom not required
- •medicine excluded)
- •4.Diagnosed diabetes
- •5.Taking any of followings affecting immunological reaction within 7
- •days (Glucocorticoid, vitamins, health food and oriental medicine etc)
- •6.History of HPV(Human Papilloma Virus) vaccination
- •7.Pregnancy and breastfeeding
- •8.Registered in other clinical trials
- •9.Patients whom the investigator considers inappropriate to participate
- •in the study
Investigators
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