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
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis B， Chronic||Drug: DA-2802 Drug: Viread®||Phase 3|
- DA-2802 319mg Group: Administration with DA-2802 319mg tablet qd and placebo tablet matching to Viread® 300mg for 0-48 weeks.
- 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|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
DA-2802 319mg tablet qd
DA-2802 319mg tablet qd + placebo tablet matching to Viread® 300mg.
Other Name: tenofovir disoproxil orotate
Active Comparator: Viread®
Viread® 300mg tablet qd
Viread® 300mg tablet qd + placebo tablet matching to DA-2802 319mg.
Other Name: tenofovir disoproxil fumarate
- Difference of HBV DNA level(log10) [ Time Frame: Change from baseline at 48 weeks ]
- 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 ]
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
|Contact: Jong eun Yeon, M.D., Ph.Dfirstname.lastname@example.org|
|Korea, Republic of|
|Korea University Guro Hospital||Recruiting|
|Seoul, Korea, Republic of, 08308|
|Contact: Jong Eun Yeon, Ph D. +82-2-2626-3010 email@example.com|
|Principal Investigator:||Jong eun Yeon||Korea University Guro Hospital|