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Trial record 35 of 228 for:    "Hepatitis B" | "Tenofovir"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02967939
Recruitment Status : Unknown
Verified September 2017 by Dong-A ST Co., Ltd..
Recruitment status was:  Recruiting
First Posted : November 18, 2016
Last Update Posted : September 13, 2017
Sponsor:
Information provided by (Responsible Party):
Dong-A ST Co., Ltd.

Tracking Information
First Submitted Date  ICMJE November 14, 2016
First Posted Date  ICMJE November 18, 2016
Last Update Posted Date September 13, 2017
Actual Study Start Date  ICMJE April 17, 2017
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 16, 2016)
Difference of HBV DNA level(log10) [ Time Frame: Change from baseline at 48 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02967939 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 16, 2016)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of DA-2802 in Chronic Hepatitis B Patients
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Hepatitis B, Chronic
Intervention  ICMJE
  • Drug: DA-2802
    DA-2802 319mg tablet qd + placebo tablet matching to Viread® 300mg.
    Other Name: tenofovir disoproxil orotate
  • Drug: Viread®
    Viread® 300mg tablet qd + placebo tablet matching to DA-2802 319mg.
    Other Name: tenofovir disoproxil fumarate
Study Arms  ICMJE
  • Experimental: DA-2802
    DA-2802 319mg tablet qd
    Intervention: Drug: DA-2802
  • Active Comparator: Viread®
    Viread® 300mg tablet qd
    Intervention: Drug: Viread®
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 16, 2016)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02967939
Other Study ID Numbers  ICMJE DA2802_HB_III
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Dong-A ST Co., Ltd.
Study Sponsor  ICMJE Dong-A ST Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jong eun Yeon Korea University Guro Hospital
PRS Account Dong-A ST Co., Ltd.
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP