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

NCT02967939 | Completed Phase 3 DMC

• 1 other identifier: DA2802_HB_III
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hepatitis B， Chronic

Outcome Measures

Primary Outcomes (1)

• Difference of HBV DNA level(log10)

  Change from baseline at 48 weeks

Secondary Outcomes (3)

• Percentage of subjects HBV DNA < 400 copies/ml

  at 24 weeks, 48 weeks

• Percentage of subjects who had normal ALT levels

  at 24 week, 48 week

• Percentage of subjects who experienced loss of HBeAg

  at 24 week, 48 week

Study Arms (2)

DA-2802

EXPERIMENTAL

DA-2802 319mg tablet qd

Drug: DA-2802

Viread®

ACTIVE COMPARATOR

Viread® 300mg tablet qd

Drug: Viread®

Interventions

DA-2802 DRUG

DA-2802 319mg tablet qd + placebo tablet matching to Viread® 300mg.

Also known as: tenofovir disoproxil orotate

DA-2802

Viread® DRUG

Viread® 300mg tablet qd + placebo tablet matching to DA-2802 319mg.

Also known as: tenofovir disoproxil fumarate

Viread®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Dong-A ST Co., Ltd.: lead

Study Sites (1)

Korea University Guro Hospital

Seoul, 08308, South Korea

Location

Related Publications (1)

• 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.

  PMID: 35315603 DERIVED

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

Tenofovir

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Jong eun Yeon

  Korea University Guro Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2016
• First Posted: November 18, 2016
• Study Start: March 28, 2017
• Primary Completion: January 23, 2019
• Study Completion: July 15, 2019
• Last Updated: April 14, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)