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

Cervical Intraepithelial Neoplasia Clinical Trial

— PGA  

Official 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01826045
• Other study ID #: UMT2012-BL-PGA-01
• Secondary ID: 12335
• Status: Completed
• Phase: Phase 2
• First received: March 29, 2013
• Last updated: January 28, 2016
• Start date: June 2013
• Est. completion date: January 2016

Study information

• Verified date: January 2016
• Source: BioLeaders Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: January 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 49 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma in Situ
• Cervical Intraepithelial Neoplasia
• Neoplasms

Intervention

Drug:
• Poly-gamma Glutamic Acid

• Placebo

Locations

Country	Name	City	State
Korea, Republic of	The Dongsan Medical Center of Keimyung Hospital	Daegu
Korea, Republic of	CHA Gangnam Hospital	Seoul
Korea, Republic of	Korea University Guro Hospital	Seoul
Korea, Republic of	Kwandong University College of Medicine Cheil Hospital	Seoul
Korea, Republic of	MiZMedi Hospital	Seoul
Korea, Republic of	The Catholic University, Korea Seoul St Mary's Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
BioLeaders Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse Events	Adverse events will be monitored for 12 weeks.	up to 12 weeks	Yes
Other	Vital Signs	Vital signs will be monitored for 12 weeks.	up to 12 weeks	Yes
Other	Laboratory Tests	Result of laboratory tests will be assessed at screening.	up to 12 weeks	Yes
Primary	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	No
Secondary	Reid Colposcopic Index	Reid Colposcopic Index will be assessed at the time of screening and 12 weeks.	up to 12 weeks	No
Secondary	Pap smear test	Result of Pap smear test will be assessed at the time of screening and 12 weeks.	up to 12 weeks	No
Secondary	HPV (Human Papilloma Virus) DNA Test	Result of HPV (Human Papilloma Virus) DNA Test will be assessed at the time of screening and 12 weeks.	up to 12 weeks	No
Secondary	HPV (Human Papilloma Virus) Hybrid CaptureII Test	Result of HPV (Human Papilloma Virus) Hybrid CaptureII Test will be assessed at the time of screening and 12 weeks.	up to 12 weeks	No
Secondary	NK (Natural Killer) Cell Activity	Result of NK (Natural Killer) Cell Activity will be assessed at the time of baseline (0day), 4 weeks, 8 weeks and 12 weeks.	up to 12 weeks	No
Secondary	Peripheral Blood Mononuclear Cells (PBMCs)Test	Result of Peripheral Blood Mononuclear Cells (PBMCs) Test will be assessed at the time of baseline (0day), 4 weeks, 8 weeks and 12 weeks.	up to 12 weeks	No