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Completed

NCT Number: NCT02195089

Efficacy and Safety Study of BLS_ILB_E710c for the Fertile Women With Cervical Intraepithelial Neoplasia(CIN3)

The purpose of this study is to determine the efficacy and the safety of BLS-ILB-E710c for the the fertile women with Cervical Intraepithelial Neoplasia (CIN3).

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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–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Korea University Guro Hospital, Seoul, South Korea

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About this study

This study is to see the regression rate of Cervical Intraepithelial Neoplasia (CIN3) and to see the inducement of Cytotoxic T Lymphocyte.

The First treatment group will be administered with BLS-ILB-E710c 500mg for 8 weeks followed by 1 week observation The Second treatment group will be administered with BLS-ILB-E710c 1000mg for 8 weeks followed by 1 week observation The Third treatment group will be administered with BLS-ILB-E710c 1500mg for 8 weeks followed by 1 week observation The fourth treatment group will be administered with BLS-ILB-E710c Optimum dose for 8 weeks followed by 8 weeks observation

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Pre-menopausal patients between age of 20 and 50.
  • Patients with cervical intraepithelial neoplasia 3(CIN3).
  • Only infection with HPV type 16.
  • Patients with Capable of observation of all of lesions by Colposcopy biopsy.
  • Be informed of the nature of the study and will give written informed consent.
  • Be agree with contraception during study
  • 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 /mm^3
  • Normal for EKG(Electrocardiography)
  • AST/ALT : 2.5 times less than normal range

Exclusion criteria

  • Autoimmune Disease or Prohibited drug(Therapy) bring about immunosuppressive.
  • Patient that has medical history of hypersensitivity about Food containing Lactic acid bacteria or Lactic acid bacteria medication.
  • Patient with Acute illness(ex. Acute Appendicitis, Myocardial infarction, Hemorrhage, meningitis etc.)
  • Investigational product within three months before the start of the drug administration to patients treated with other test drug.
  • Patient with Chronic pancreatitis currently or Patients diagnosed with acute pancreatitis.
  • Organopathy Patient with Inflammatory intestine·bowel disease, gastrointestinal tumors, ulcers, bleeding, perforation etc.
  • Pregnant or lactating women
  • Patient with HBV or HCV infection (except for Asymptomatic)
  • Patient that Investigator judge
  • Deemed inappropriate for researchers to judge the patient

Treatment and study plan

BLS_ILS_E710c 500mg

Drug
  • 2 capsules per day for 20 days (week 1,2,4 & 8)

Other names: CIN3 Theraputic Vaccine

BLS_ILB_710c 1000mg

Drug
  • 4 capsules per day for 20 days (week 1,2,4 & 8)

Other names: CIN3 Theraputic Vaccine

BLS_ILS_E710c 1500mg

Drug
  • 6 capsules per day for 8 weeks (week 1,2,4 & 8)

Other names: CIN3 Theraputic Vaccine

Primary outcomes

  1. Phase 1 : Safety

    Time frame: up to 9 weeks

    Dose Limiting Toxicity(DLT) is assessed by NCI-CTC version 4.0

  2. Phase 2a : Regression rate

    Time frame: screening and 9 weeks(option), 16 weeks.

    Regression rate will be assessed at the time of screening and 9 weeks(option), 16 weeks. Regression means the change from the stage of CIN1 to normal

Secondary outcomes

  1. Reid Colposcopic Index

    Time frame: Phase 1 : up to 9 weeks

    Reid Colposcopic Index will be assessed at the time of screening,4 weeks 9.

  2. Reid Colposcopic Index

    Time frame: Phase 2a : up to 16 weeks

    Reid Colposcopic Index will be assessed at the time of screening,4 weeks, 9 weeks, 12 weeks, 16 weeks

  3. Serum anti-E7 antibody

    Time frame: 1 week, 9 weeks, 16 weeks

    Serum anti-E7 antibody will be assessed at the time of 1 week, 9 weeks, 16 weeks.

Sponsors and collaborators

Lead sponsor

BioLeaders Corporation

Industry

Registry information

Official study title

A Phase 1/2a Trial to Evaluate the Efficacy and the Safety of BLS_ILB_E710c for the Fertile Women With Cervical Intraepithelial Neoplasia(CIN3)

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jul 21, 2014
Registry last updated
Apr 19, 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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