Trials / Completed
CompletedNCT02224456
Efficacy and Safety Study of Tenofovir Disoproxil Fumarate (TDF) in Chinese Chronic Hepatitis B (CHB) Subjects With Advanced Fibrosis & Compensated Cirrhosis
A Prospective, Multi-center, Cohort Study to Evaluate the Efficacy and Safety of Tenofovir Disoproxil Fumarate (TDF) Therapy in Chinese Chronic Hepatitis B (CHB) Subjects With Advanced Fibrosis & Compensated Cirrhosis
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 197 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Not accepted
Summary
Chronic Hepatitis B infection (CHB) is known as the most frequently identified cause of liver disease that predisposes patients to the development of hepatocellular carcinoma (HCC). Active hepatitis B virus (HBV) replication is the key driver of liver injury and disease progression. Majority of Chinese patients are infected with genotype B and C HBV, which is different from Caucasian counterparts. This prospective multi-center cohort open-label study is designed to investigate the long-term effect of TDF on prevention of HCC and disease progression as well as to evaluate the efficacy and safety of long-term TDF in Chinese CHB subjects with advanced liver diseases. The study will enrol 240 subjects.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tenofovir disoproxil fumarate | White, almond-shaped, film-coated tablet containing 300 mg of TDF, debossed with "GILEAD" and "4331" on one side of the tablet. |
Timeline
- Start date
- 2015-03-25
- Primary completion
- 2020-12-04
- Completion
- 2020-12-04
- First posted
- 2014-08-25
- Last updated
- 2022-02-14
- Results posted
- 2022-02-14
Locations
19 sites across 1 country: China
Source: ClinicalTrials.gov record NCT02224456. Inclusion in this directory is not an endorsement.