Trials / Completed
CompletedNCT02967939
Efficacy and Safety of DA-2802 in Chronic Hepatitis B Patients
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 123 (actual)
- Sponsor
- Dong-A ST Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | DA-2802 | DA-2802 319mg tablet qd + placebo tablet matching to Viread® 300mg. |
| DRUG | Viread® | Viread® 300mg tablet qd + placebo tablet matching to DA-2802 319mg. |
Timeline
- Start date
- 2017-03-28
- Primary completion
- 2019-01-23
- Completion
- 2019-07-15
- First posted
- 2016-11-18
- Last updated
- 2021-04-14
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT02967939. Inclusion in this directory is not an endorsement.