Last updated on September 2017

A Trial to Evaluate the Efficacy and Safety of BLS-ILB-E710c in Patients With Cervical Intraepithelial Neoplasia 2/3 (CIN2/3)


Brief description of study

This study evaluates the efficacy and safety of the experimental drug, BLS-ILB-E710c, in patients with Cervical Intraepithelial Neoplasia 2/3 (CIN2/3). 2/3 of participants will receive the experimental drug, while 1/3 of participants will receive placebo.

Detailed Study Description

Primary Outcome Measure: Complete histopathological regression from baseline [Time Frame: Baseline through Week 16] Secondary Outcome Measures: - Change from baseline of CIN classification [Time Frame: Baseline through Week 16] - Change from baseline of RCI [Time Frame: Baseline through Week 16 and Week 32] - Change from baseline of cytopathological classification based on bethesda system [Time Frame: Baseline through Week 16 and Week 32] - Change from baseline as compared to placebo in the expression rate of P16/Ki-67 [Time Frame: Baseline through Week 16] - Change from baseline as compared to placebo of the number of CD8 positive cells in the cervical tissue [Time Frame: Baseline through Week 16] - Change from baseline as compared to placebo in HPV 16 clearance rate - Change of RCI based on the histopathological regression at Week 16 [Time Frame: Week 16 through Week 32]

Clinical Study Identifier: NCT03274206

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Nak-Woo Lee, MD, PhD

Korea University Ansan Hospital
Ansan, Korea, Republic of
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Sung Jong Lee, MD, PhD

Catholic University of Korea, St. Vincent's Hospital
Suwon, Korea, Republic of
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Jin Hui Kim, MD

Catholic University of Korea, Uijeongbu St. Mary's Hospital
Uijeongbu, Korea, Republic of
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Chi-Heum Cho, MD, PhD

The Dongsan Medical Center of Keimyung Hospital
Daegu, Korea, Republic of
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Jin Woo Shin, MD, PhD

Gachon University Gil Medical Center
Incheon, Korea, Republic of
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Young Tae Kim, MD, PhD

Yonsei Unversity Health System
Seoul, Korea, Republic of
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Jong Sup Park, MD, Ph.D

Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, Korea, Republic of
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Sung Taek Park, MD, PhD

Hallym University Medical Center
Seoul, Korea, Republic of
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Tae Jin Kim, MD, PhD

Kwandong University College of Medicine Cheil Hospital
Seoul, Korea, Republic of
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Seok Ju Seong, MD, PhD

CHA Gangnam Hospital
Seoul, Korea, Republic of
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Jae-Kwan Lee, MD, PhD

Korea University Guro Hospital
Seoul, Korea, Republic of
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