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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


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
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