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Efficacy and Safety of Tenofovir Disoproxil Fumarate (TDF) 300mg in Chinese Subjects With Chronic Hepatitis B (CHB)

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatitis B

Intervention: Tenofovir disoproxil fumarate (TDF) tablets (Drug); Adefovir dipivoxil (ADV) tablets (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

Summary

This is a multi-centre, double blind, double dummy, randomised, controlled study to evaluate the efficacy and safety of TDF 300mg QD versus ADV 10mg QD in Chinese subjects with CHB. This study is designed to demonstrate the superiority of TDF 300mg QD over ADV 10mg QD in treating Chinese subjects with CHB (hepatitis B e antigen [HBeAg] positive subjects and HBeAg negative subjects). It will also provide long-term efficacy and safety data (up to 240 weeks) for TDF 300 mg administered once daily.

Clinical Details

Official title: A Multi-centre, Double Blind, Double Dummy, Randomised, Controlled Study to Evaluate the Efficacy and Safety of TDF 300mg Once Daily (QD) Versus Adefovir Dipivoxil (ADV) 10mg QD in Chinese Subjects With CHB

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Participants With Hepatitis B Virus (HBV) DNA <400 Copies/Milliliter (mL) at Week 48

Secondary outcome:

Participants With HBV DNA <400 Copies/mL at Weeks 96, 144, 192, and 240

Log 10 Copies/mL Reduction From Baseline HBV DNA at Week 48

Number of Participants With Alanine Aminotransferase (ALT) Normalization at Week 48 in Participants Who Had Abnormal ALT at Baseline

Number of Participants With Histological Improvement at Week 48 Who Had a Baseline Knodell Necroinflammatory Score (KNS) >=2

Number of HBeAg-positive Participants Achieving HBeAg Loss and HBeAg Seroconversion at Weeks 24 and 48

Number of HBeAg-positive Participants Achieving HBsAg Loss and HBsAg Seroconversion at Weeks 24 and 48

Number of HBeAg-negative Participants Achieving HBsAg Loss and HBsAg Seroconversion at Weeks 24 and 48

Number of Participants Achieving Durable HBsAg Loss From Weeks 24 to Week 48

Number of Participants With Virological Breakthrough at Week 48

Number of Participants With Any Serious Adverse Event (SAE) and Any Adverse Event (AE)

Number of Participants With the Indicated Grade 3 and Grade 4 Treatment-emergent (TE) Laboratory Abnormalities (LAs)

Number of Participants With the Indicated Treatment-emergent Laboratory Abnormalities for Serum Creatinine and Serum Phosphorus

Number of Participants in the Indicated Category for Hepatic Laboratory Abnormalities

Detailed description: This is a multi-centre, double-blind, double-dummy, randomised, controlled study to evaluate the efficacy and safety of TDF 300mg QD versus ADV 10mg QD in Chinese subjects with CHB. Four hundred and ninety-four subjects with CHB (200 HBeAg positive subjects and 294 HBeAg negative subjects) will be randomised (1: 1ratio) to either TDF 300mg QD or ADV 10mg QD treatment arms. The primary endpoint is the proportion of subjects with blood hepatitis B virus (HBV) deoxyribonucleic acid (DNA) <400copies/mL (Roche COBAS Taqman HBV test) at Week 48 in HBeAg positive subjects with CHB and HBeAg negative subjects with CHB. This is a two-part study. The first treatment period (baseline to Week 48) will investigate the effects of TDF and ADV on safety and efficacy endpoints; dosing will be double-blind. This period will be followed by 192 weeks in which all subjects will receive open-label TDF (Week 49 to Week 240). Subjects will undergo regular safety and efficacy assessments every 4 weeks for the first 12 weeks followed by every 12 weeks for a total of up to 5 years.

Eligibility

Minimum age: 18 Years. Maximum age: 69 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- HBeAg positive/negative CHB with blood HBVDNA≥10^5 copies/mL and elevated ALT

- Nucleoside and nucleotide naïve CHB subjects. Previous lamivudine treatment is

allowed in less than 10% of the total study population Exclusion Criteria:

- subjects with hepatocellular carcinoma (HCC) potential or decompensated liver disease

- subjects with acute liver disease due to other causes

- subjects with medication history of immunosuppressive therapy, immunomodulatory

therapy, systemic cytotoxic agents, chronic antiviral agents including Chinese herbal medicines known to have activity against HBV (e. g., lamivudine, hepatitis B immunoglobulin (HBIg)) within the previous 6 months prior to randomisation into this study

Locations and Contacts

GSK Investigational Site, Beijing 100050, China

GSK Investigational Site, Beijing 100044, China

GSK Investigational Site, Beijing 100015, China

GSK Investigational Site, Chongqing 400038, China

GSK Investigational Site, Fuzhou 350025, China

GSK Investigational Site, Jinan 250021, China

GSK Investigational Site, Shanghai 201508, China

GSK Investigational Site, Shanghai 200001, China

GSK Investigational Site, Shanghai 200025, China

GSK Investigational Site, Shanghai 200040, China

GSK Investigational Site, Guangzhou, Guangdong 510515, China

GSK Investigational Site, Guangzhou, Guangdong 510630, China

GSK Investigational Site, Guangzhou, Guangdong 510060, China

GSK Investigational Site, Wuhan, Hubei 430030, China

GSK Investigational Site, Changsha, Hunan 410008, China

GSK Investigational Site, Nanjing, Jiangsu 210029, China

GSK Investigational Site, Nanjing, Jiangsu 210003, China

GSK Investigational Site, Changchun, Jilin 130021, China

GSK Investigational Site, Chengdu, Sichuan 610041, China

GSK Investigational Site, Hangzhou, Zhejiang 310003, China

Additional Information

Starting date: March 2011
Last updated: July 23, 2015

Page last updated: August 23, 2015

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