Efficacy and Safety of DA-2802 in Chronic Hepatitis B Patients

NCT02967939 ↗

Phase 3 Completed 123 enrolled Dong-A ST Co., Ltd.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

A study demonstrates the non-inferiority of DA-2802 when compared with ㅍViread® in chronic hepatitis B patients

Timeline

Start: 2017-03-28
Primary completion: 2019-01-23
Completion: 2019-07-15

Outcome

Met primary endpoint

paper The analysis of primary endpoint using the nonparametric analysis of covariance showed statistically significant results (P < 0.001), PMID 35315603 ↗

paper which confirmed non-inferiority of DA-2802 to Viread® by a prespecified noninferiority margin of 1. PMID 35315603 ↗

Publications

Kim HJ, Kim JH, Yeon JE, Seo YS, Jang JW, Cho YK, Jang BK, Han BH, Lee C, Lee JH, Yoon JH, Kim KM, Kim MY, Kim DY, Park NH, Cho EY, Lee JS, Lee JW, Kim IH, Song BC, Lee BS, Kwon OS. A Multi-Center, Double-Blind Randomized Controlled Phase III Clinical Trial to Evaluate the Antiviral Activity and Safety of DA-2802 (Tenofovir Disoproxil Orotate) and Viread (Tenofovir Disoproxil Fumarate) in Chronic Hepatitis B Patients. J Korean Med Sci. 2022 Mar 21;37(11):e92. doi: 10.3346/jkms.2022.37.e92.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	DA-2802	Unknown	319 mg	—
Comparator	Tenofovir disoproxil fumarate	Small molecule	300 mg	—