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Trial record 72 of 314 for:    hepatitis b | Recruiting, Not yet recruiting, Available Studies

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

This study is currently recruiting participants.
See Contacts and Locations
Verified September 2017 by Dong-A ST Co., Ltd.
Sponsor:
Information provided by (Responsible Party):
Dong-A ST Co., Ltd.
ClinicalTrials.gov Identifier:
NCT02967939
First received: November 14, 2016
Last updated: September 12, 2017
Last verified: September 2017
  Purpose
A study demonstrates the non-inferiority of DA-2802 when compared with ㅍViread® in chronic hepatitis B patients

Condition Intervention Phase
Hepatitis B, Chronic Drug: DA-2802 Drug: Viread® Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Dong-A ST Co., Ltd.:

Primary Outcome Measures:
  • Difference of HBV DNA level(log10) [ Time Frame: Change from baseline at 48 weeks ]

Secondary Outcome Measures:
  • Percentage of subjects HBV DNA < 400 copies/ml [ Time Frame: at 24 weeks, 48 weeks ]
  • Percentage of subjects who had normal ALT levels [ Time Frame: at 24 week, 48 week ]
  • Percentage of subjects who experienced loss of HBeAg [ Time Frame: at 24 week, 48 week ]

Estimated Enrollment: 120
Actual Study Start Date: April 17, 2017
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DA-2802
DA-2802 319mg tablet qd
Drug: DA-2802
DA-2802 319mg tablet qd + placebo tablet matching to Viread® 300mg.
Other Name: tenofovir disoproxil orotate
Active Comparator: Viread®
Viread® 300mg tablet qd
Drug: Viread®
Viread® 300mg tablet qd + placebo tablet matching to DA-2802 319mg.
Other Name: tenofovir disoproxil fumarate

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02967939

Contacts
Contact: Jong eun Yeon, M.D., Ph.D +82-2-2626-3010 jeyyeon@hotmail.com

Locations
Korea, Republic of
Korea University Guro Hospital Recruiting
Seoul, Korea, Republic of, 08308
Contact: Jong Eun Yeon, Ph D.    +82-2-2626-3010    jeyyeon@hotmail.com   
Sponsors and Collaborators
Dong-A ST Co., Ltd.
Investigators
Principal Investigator: Jong eun Yeon Korea University Guro Hospital
  More Information

Responsible Party: Dong-A ST Co., Ltd.
ClinicalTrials.gov Identifier: NCT02967939     History of Changes
Other Study ID Numbers: DA2802_HB_III
Study First Received: November 14, 2016
Last Updated: September 12, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Tenofovir
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents

ClinicalTrials.gov processed this record on September 21, 2017