Tenofovir Disoproxil Fumarate (TDF) 300mg 3 Years RD Therapy Chinese Chronic Hepatitis B (CHN) CHB Multiple Nucleos(t)Ide Analogues (NAs) Failure Points Pts PH4 PMS Study

PHASE4CompletedINTERVENTIONAL
Enrollment

213

Participants

Timeline

Start Date

March 18, 2015

Primary Completion Date

August 14, 2018

Study Completion Date

August 14, 2018

Conditions
Hepatitis B, Chronic
Interventions
DRUG

Tenofovir disoproxil fumarate

Tenofovir disoproxil fumarate tablets supplied will be white, almond-shaped, film-coated tablets containing 300 mg of TDF. Each tablet contains the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, pregelatinised starch, croscarmellose sodium, and magnesium stearate.

Trial Locations (12)

100034

GSK Investigational Site, Beijing

100044

GSK Investigational Site, Beijing

100050

GSK Investigational Site, Beijing

100054

GSK Investigational Site, Beijing

200025

GSK Investigational Site, Shanghai

200040

GSK Investigational Site, Shanghai

310000

GSK Investigational Site, Hangzhou

510060

GSK Investigational Site, Guangzhou

510150

GSK Investigational Site, Guangzhou

610041

GSK Investigational Site, Chengdu

Unknown

GSK Investigational Site, Changchun

GSK Investigational Site, Zhengzhou

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT02195518 - Tenofovir Disoproxil Fumarate (TDF) 300mg 3 Years RD Therapy Chinese Chronic Hepatitis B (CHN) CHB Multiple Nucleos(t)Ide Analogues (NAs) Failure Points Pts PH4 PMS Study | Biotech Hunter | Biotech Hunter