Clinical trial NCT02967939: Efficacy and Safety of DA-2802 in Chronic Hepatitis B Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis B， Chronic
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-11-18
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: 1. DA-2802 319mg Group: Administration with DA-2802 319mg tablet qd and placebo tablet matching to Viread® 300mg for 0-48 weeks.
2. Viread® 300mg Group: Administration with Viread® 300mg tablet qd and placebo tablet matching to DA-2802 319mg for 0-48 weeks.

Eligibility criteria: Inclusion Criteria:

* Patients with chronic hepatitis B aged 18 years or older
* Subjects who have evidence to demonstrate a history of chronic hepatitis B for at least six months from the time of screening visit
* Subjects who have HBsAg positive test at screening visit
* Subjects who did not receive the hepatitis B treatment, including interferon or pegylated interferon, within 24 weeks of starting the screening test
* Subjects with an ALT of 80 units or more and 10 times lower than the normal upper limit at the time of screening

Exclusion Criteria:

* Subjects infected with hepatitis C, hepatitis D or human immunodeficiency virus
* Subjects with creatinine clearance of less than 50 ml/min at the screening visit
* At the time of screening visit, alpha-fetoprotein level was higher than 50 ng/ml and related imaging test showed hepatocellular carcinoma
* Subjects with decompensated liver disease who meet the following criteria:

  1. Total bilirubin levels greater than 2.5 mg/dl
  2. Prothrombin time is at least 3 seconds longer than normal upper limit
  3. Serum albumin value less than 30 g/l
  4. Subjects with a history of ascites, jaundice, bleeding from varicose veins, hepatic encephalopathy, or other signs of liver failure.

Primary outcomes:
measure: Difference of HBV DNA level(log10)
timeFrame: Change from baseline at 48 weeks
Secondary outcomes:
measure: Percentage of subjects HBV DNA < 400 copies/ml
timeFrame: at 24 weeks, 48 weeks
measure: Percentage of subjects who had normal ALT levels
timeFrame: at 24 week, 48 week
measure: Percentage of subjects who experienced loss of HBeAg
timeFrame: at 24 week, 48 week
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
Study officials:
affiliation: Korea University Guro Hospital
name: Jong eun Yeon
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.