Phase 3 and Extensional Study of Besifovir

Summary

To prove that a study drug is noninferior to a control drug with a proportion of subjects who showed HBV DNA undetected (less than 400 copies/mL (69 IU/mL)) at the 48th week after 48-week administration of Besifovir 150 mg, or Tenofovir 300 mg as a control drug to chronic hepatitis B patients

Conditions

• Chronic Hepatitis B

Interventions

DRUG

besifovir 150mg

Besifovir 150 mg q.d. + Placebo of Tenofovir Disoproxil Fumarate 300 mg q.d. + L-carnitine (L-Carn Tab. 330 mg) 660 mg q.d.

DRUG

tenofovir 300mg

Placebo of Besifovir 150 mg q.d. + Tenofovir Disoproxil Fumarate 300 mg q.d. + Placebo of L-carnitine (L-Carn Tab. 330 mg) 660 mg q.d.

Sponsors & Collaborators

• IlDong Pharmaceutical Co Ltd

  lead INDUSTRY

Principal Investigators

• Kwan Sik Lee, M.d., Ph.D · Kangnam Severance Hospital, Yonsei University, Seoul, Korea

• Young Oh Kweon, M.D., Ph.D · Kyungpook National University Hospital, Seoul, Korea

• Hyung Joon Yim, M.D., Ph.D. · Korea University Medical Center, Ansan, Kyunggi-do, Korea

• Soon Ho Um, M.D., Ph.D. · Korea University Medical Center, Seoul, Korea

• Won Kim, M.D., Ph.D. · Seoul National University Boramae medical Center, Seoul, Korea

• Sung Jae Park, M.D., Ph.D. · Inje University Busan Paik Hospital, Pusan, Korea

• Yoon Jun Kim, M.D., Ph.D. · Seoul National University Hospital, Seoul, Korea

• Yoon Jun Kim, M.D., Ph.D. · The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul, Korea

• Young-Suk Lim, M.D., Ph.D. · Asan Medical Center, Seoul, Korea

• JinMo Yang, M.D., Ph.D. · The Catholic University of Korea, Seoul St. Vincent's Hospital, Seoul, Korea

• Jang, Jae Young, M.D., Ph.D. · Soonchunhyang University Hospital, Seoul, Korea

• Jae-Youn Cheong, M.D., Ph.D. · Ajou University Medical Center, Suwon, Kyunggi-do, Korea

• Neung Hwa Park, M.D., Ph.D. · Ulsan University Hospital, Ulsan, Korea

• Moon Young Kim, M.D., Ph.D. · Wonju Sevrerance Christian Hospital, Wonju, Kangwon-do, Korea

• Jin-Woo Lee, M.D., Ph.D. · Inha University Hospital, Incheon, Inchen, Korea

• Dong Joon Kim, M.D., Ph.D. · Hallym University Medical Center, ChunCheon, Kangwon-do, Korea

• Byung Seok Lee, M.D., Ph.D. · Chungnam National University Hospital

• Joo Hyun Sohn, M.D., Ph.D. · Hanyang University Guri Hospital, Guri, Kyunggi-do, Korea

• Kwang-Hyub Han, M.D., Ph.D. · Severance Hospital of Yonsei University, Seoul, Korea

• Hong Soo Kim, M.D., Ph.D. · Soonchunhyang University Hospital, Choenan, Chungchoengnam-do, Korea

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

20 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-10-31

Primary Completion

2016-02-29

Completion

2023-01-31

Countries

• South Korea

Study Locations