Efficacy and Safety Study of PGA (Poly-gamma Glutamic Acid) for Cervical Intraepithelial Neoplasia

NCT01826045 | Completed Phase 2 DMC

• 2 other identifiers: UMT2012-BL-PGA-0112335
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 7

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).

Conditions

Cervical Intraepithelial Neoplasia

Keywords

Treatment of Cervical Intraepithelial Neoplasia(CIN1)

Outcome Measures

Primary Outcomes (1)

• Regression rate

  Regression rate will be assessed at the time of screening and 12 weeks. Regression means the change from the stage of CIN1 to normal.

  up to 12 weeks

Secondary Outcomes (6)

• Reid Colposcopic Index

  up to 12 weeks

• Pap smear test

  up to 12 weeks

• HPV (Human Papilloma Virus) DNA Test

  up to 12 weeks

• HPV (Human Papilloma Virus) Hybrid CaptureII Test

  up to 12 weeks

• NK (Natural Killer) Cell Activity

  up to 12 weeks

Other Outcomes (3)

• Adverse Events

  up to 12 weeks

• Vital Signs

  up to 12 weeks

• Laboratory Tests

  up to 12 weeks

Study Arms (2)

Poly-gamma Glutamic Acid

EXPERIMENTAL

Patients with cervical intraepithelial neoplasia 1(CIN1) will be administered Poly-gamma Glutamic Acid for 4 weeks.

Drug: Poly-gamma Glutamic Acid

Placebo

PLACEBO COMPARATOR

Patients with cervical intraepithelial neoplasia 1(CIN1) will be administered placebo for 4 weeks.

Drug: Placebo

Interventions

Poly-gamma Glutamic Acid DRUG

Poly-gamma Glutamic Acid

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 20 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• BioLeaders Corporation: lead

Study Sites (7)

Korea University Guro Hospital

Seoul, Seoul, 152-703, South Korea

Location

The Dongsan Medical Center of Keimyung Hospital

Daegu, 700-712, South Korea

Location

Kwandong University College of Medicine Cheil Hospital

Seoul, 100-380, South Korea

Location

CHA Gangnam Hospital

Seoul, 135-913, South Korea

Location

The Catholic University, Korea Seoul St Mary's Hospital

Seoul, 137-701, South Korea

Location

Korea University Guro Hospital

Seoul, 152-703, South Korea

Location

MiZMedi Hospital

Seoul, 157-723, South Korea

Location

Related Publications (1)

• 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.

  PMID: 31220105 DERIVED

MeSH Terms

Conditions

Uterine Cervical Dysplasia

Interventions

poly(gamma-glutamic acid)

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Jae-Kwan Lee, MD, PhD

  Korea University Guro Hospital

  PRINCIPAL INVESTIGATOR

• Tae Jin Kim, MD, PhD

  Kwandong University College of Medicine Cheil Hospital

  PRINCIPAL INVESTIGATOR

• Jong Sup Park, MD, PhD

  The Catholic University, Korea Seoul St Mary's Hospital

  PRINCIPAL INVESTIGATOR

• Chi-Heum Cho, MD, PhD

  The Dongsan Medical Center of Keimyung University

  PRINCIPAL INVESTIGATOR

• Seok Ju Seong, MD, PhD

  CHA University

  PRINCIPAL INVESTIGATOR

• Yongsoo Park, MD, PhD

  MizMedi Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2013
• First Posted: April 8, 2013
• Study Start: June 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: January 1, 2016
• Last Updated: January 29, 2016

Record last verified: 2016-01

Locations

KR (7)