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Trial record 72 of 322 for:    hepatitis b | Recruiting, Not yet recruiting, Available Studies

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

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ClinicalTrials.gov Identifier: NCT02967939
Recruitment Status : Recruiting
First Posted : November 18, 2016
Last Update Posted : September 13, 2017
Sponsor:
Information provided by (Responsible Party):
Dong-A ST Co., Ltd.

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

Condition or disease Intervention/treatment Phase
Hepatitis B, Chronic Drug: DA-2802 Drug: Viread® Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
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
Actual Study Start Date : April 17, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



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

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


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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Dong-A ST Co., Ltd.
ClinicalTrials.gov Identifier: NCT02967939     History of Changes
Other Study ID Numbers: DA2802_HB_III
First Posted: November 18, 2016    Key Record Dates
Last Update Posted: September 13, 2017
Last Verified: September 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