Clinical trial · Interventional
Efficacy and Safety Study of PGA (Poly-gamma Glutamic Acid) for Cervical Intraepithelial Neoplasia
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)
NCT01826045CI-TRIAL-00020710PGAcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Intraepithelial Neoplasia | Cervical Intraepithelial Neoplasia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Drug | — | UNRESOLVED |
| Poly-gamma Glutamic Acid | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Poly-gamma Glutamic Acid
- description
- Patients with cervical intraepithelial neoplasia 1(CIN1) will be administered Poly-gamma Glutamic Acid for 4 weeks.
- interventionNames
- Drug: Poly-gamma Glutamic Acid
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Patients with cervical intraepithelial neoplasia 1(CIN1) will be administered placebo for 4 weeks.
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Regression rate
- timeFrame
- up to 12 weeks
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 49 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDCho 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. PMID 31220105