Study to Assess the Antiviral Activity and Safety Endpoints for the Treatment of Besifovir 150mg Compared to Tenofovir 300mg in Chronic Hepatitis B Patients Who Have Resistance to Nucleoside Analogues (HBV)
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|ClinicalTrials.gov Identifier: NCT02792088|
Recruitment Status : Recruiting
First Posted : June 7, 2016
Last Update Posted : June 8, 2016
|Condition or disease||Intervention/treatment||Phase|
|Chronic Hepatitis B||Drug: Besifovir 150mg Drug: Tenofovir 300mg||Phase 3|
- Screening Period Subject registration is conducted with confirming selection and exclusion criteria after a written consent form is obtained within 42 days before clinical trial drug administration.
- Baseline Subjects who visit on the date of starting clinical trial drug administration are randomized to a test group or a control group at a ratio of 1:1. Double blindness is applied for both groups.
- Treatment period Subjects are orally administered with a clinical trial drug q.ds.i.d. for 48 weeks and visit at the 0, 4th, 12th, 24th, 36th, and 48th week for an HBV DNA test, laboratory tests, a physical test, vital signs, and adverse events.
- Follow-up period Subjects are provided with appropriate treatment after completing the 48-week trial or dropping out. Subjects visit once at the 60th week for follow-up of adverse events, such as acute deterioration of hepatitis B, and HBV DNA test results. If any treatment is not conducted after 48-week administration, subjects visit at intervals of four weeks until a follow-up visit (60th week) and the same tests with the 24th week visit (Visit 5) are conducted. However, subjects who participate in a 48-week separate extended trial conducted after 48-week administration in this clinical trial do not have a follow-up period.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||244 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase III, Multi-center, Randomized, Double-blinded, Parallel Study to Assess the Antiviral Activity and Safety Endpoints for the Treatment of Besifovir 150mg Compared to Tenofovir 300mg in Chronic Hepatitis B Patients Who Have Resistance to Nucleoside Analogues|
|Study Start Date :||July 2015|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2017|
Besifovir 150 mg q.d.
Drug: Besifovir 150mg
Besifovir 150 mg q.d. + Placebo of Tenofovir Disoproxil Fumarate 300 mg q.d. + L-carnitine (L-Carn Tab. 330 mg) 660 mg q.d.
Other Name: Besifovir
Active Comparator: Tenofovir
Tenofovir 300 mg q.d.
Drug: Tenofovir 300mg
Placebo of Besifovir 150 mg q.d. + Tenofovir Disoproxil Fumarate 300 mg q.d. + Placebo of L-carnitine (L-Carn Tab. 330 mg) 660 mg q.d.
Other Name: Tenofovir
- The rate of subjects who showed HBV DNA undetected (less than 400 copies/mL (69 IU/mL)) at the 48th week [ Time Frame: at the 48th week ]
- The rate of subjects who showed ALT normalized at the 48th week [ Time Frame: at the 48th 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): NCT02792088
|Contact: Junghee Won, Masteremail@example.com|
|Contact: Yoan Park, Masterfirstname.lastname@example.org|
|Korea, Republic of|
|Severance Hospital of Yonsei University||Recruiting|
|Seoul, Korea, Republic of|
|Contact: Kwang-Hyub Han, M.D., Ph.D.|
|Principal Investigator: Kwang-Hyub Han, M.D., Ph.D.|
|Principal Investigator:||Kwang-Hyub Han, M.D, Ph.D.||Severance Hospital of Yonsei University|