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Completed

NCT Number: NCT01826045

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

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).

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Key information

Conditions

Cervical Intraepithelial Neoplasia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Neoplasms Precancerous Conditions Urogenital Diseases Uterine Cervical Diseases Uterine Cervical Dysplasia Uterine Diseases

Age range

20 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Korea University Guro Hospital, Seoul, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Poly-gamma Glutamic Acid

Drug

Placebo

Drug

Primary outcomes

  1. Regression rate

    Time frame: up to 12 weeks

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

Secondary outcomes

  1. Reid Colposcopic Index

    Time frame: up to 12 weeks

    Reid Colposcopic Index will be assessed at the time of screening and 12 weeks.

  2. Pap smear test

    Time frame: up to 12 weeks

    Result of Pap smear test will be assessed at the time of screening and 12 weeks.

  3. HPV (Human Papilloma Virus) DNA Test

    Time frame: up to 12 weeks

    Result of HPV (Human Papilloma Virus) DNA Test will be assessed at the time of screening and 12 weeks.

  4. HPV (Human Papilloma Virus) Hybrid CaptureII Test

    Time frame: up to 12 weeks

    Result of HPV (Human Papilloma Virus) Hybrid CaptureII Test will be assessed at the time of screening and 12 weeks.

  5. NK (Natural Killer) Cell Activity

    Time frame: up to 12 weeks

    Result of NK (Natural Killer) Cell Activity will be assessed at the time of baseline (0day), 4 weeks, 8 weeks and 12 weeks.

  6. Peripheral Blood Mononuclear Cells (PBMCs)Test

    Time frame: up to 12 weeks

    Result of Peripheral Blood Mononuclear Cells (PBMCs) Test will be assessed at the time of baseline (0day), 4 weeks, 8 weeks and 12 weeks.

Other outcomes

  1. Adverse Events

    Time frame: up to 12 weeks

    Adverse events will be monitored for 12 weeks.

  2. Vital Signs

    Time frame: up to 12 weeks

    Vital signs will be monitored for 12 weeks.

  3. Laboratory Tests

    Time frame: up to 12 weeks

    Result of laboratory tests will be assessed at screening.

Sponsors and collaborators

Lead sponsor

BioLeaders Corporation

Industry

Registry information

Official study 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)

Acronym: PGA

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Apr 8, 2013
Registry last updated
Jan 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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