Last updated: 07/17/2024 15:40:25
Efficacy and safety of tenofovir disoproxil fumarate (TDF) 300mg in Chinese subjects with chronic hepatitis B (CHB)TDF in CHB
GSK study ID
114648
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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
Trial 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. 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Participants with Hepatitis B Virus (HBV) deoxyribonucleic acid (DNA) <400 copies/milliliter (mL) at Week 48
Timeframe: Week 48
Secondary outcomes:
Participants with HBV DNA <400 copies/mL at Weeks 96, 144, 192, and 240
Timeframe: Weeks 96, 144, 192, and 240
Change from Baseline of Log 10 copies/mL HBV DNA at Weeks 48, 96, 144, 192 and 240
Timeframe: Baseline, Weeks 48, 96, 144, 192 and 240
Number of participants with alanine aminotransferase (ALT) normalization at Weeks 48, 96, 144, 192 and 240 in participants who had abnormal ALT at Baseline
Timeframe: Baseline; Weeks 48, 96, 144, 192 and 240
Number of participants with histological improvement at Weeks 48 and 240 who had a Baseline Knodell Necroinflammatory Score (KNS) >=2.
Timeframe: Baseline; Week 48 and Week 240
Number of HBeAg-positive participants achieving HBeAg loss and HBeAg seroconversion at Weeks 24, 48, 96, 144, 192 and 240.
Timeframe: Weeks 24, 48, 96, 144, 192 and 240
Number of HBeAg-positive participants achieving Hepatitis B surface Antigen (HBsAg) loss and HBsAg seroconversion at Weeks 24, 48, 96, 144, 192 and 240
Timeframe: Weeks 24, 48, 96, 144, 192 and 240
Number of HBeAg-negative participants achieving HBsAg loss and HBsAg seroconversion at Weeks 24, 48, 96, 144, 192, 240
Timeframe: Weeks 24, 48, 96, 144, 192 and 240
Number of participants achieving durable HBsAg loss from Weeks 24 to Week 48
Timeframe: Week 24 to Week 48
Number of participants achieving durable HBsAg loss from Weeks 96 to Week 240
Timeframe: Week 96 to Week 240
Number of participants with virological breakthrough at Weeks 48, 96, 144, 192 and 240
Timeframe: Weeks 48, 96, 144, 192 and 240
Number of participants with any Serious Adverse Event (SAE) and any non-serious adverse event (AE)
Timeframe: Up to Week 240 treatment period and 24 weeks follow-up visit off treatment
Number of participants with the indicated Grade 3 and Grade 4 treatment-emergent (TE) laboratory abnormalities (LAs)
Timeframe: Up to Week 240
Number of participants with the indicated treatment-emergent laboratory abnormalities for serum creatinine and serum phosphorus
Timeframe: Up to Week 240
Number of participants in the indicated category for renal laboratory abnormalities
Timeframe: Up to Week 240
Interventions:
Drug: Tenofovir disoproxil fumarate (TDF) tablets
Drug: Adefovir dipivoxil (ADV) tablets
Enrollment:
512
Observational study model:
Not applicable
Primary completion date:
2012-17-10
Time perspective:
Not applicable
Clinical publications:
Xieer Liang, Zhiliang Gao, Qing Xie, Jiming Zhang, Jifang Sheng, Jun Cheng, Chengwei Chen, Qing Mao, Wei Zhao, Hong Ren, Deming Tan, Junqi Niu, Shijun Chen, Chen Pan, Hong Tang, Hao Wang, Yimin Mao, Jidong Jia, Qin Ning, Min Xu, Shanming Wu, Jun Li, Xinxin Zhang, Wenyan Zhang, Cui Xiong, Jinlin Hou.Long-term efficacy and safety of tenofovir disoproxil fumarate in Chinese patients with chronic hepatitis B: 5-year results.Hepatol Intl.2019;13(3):260–269
DOI: 10.1007/s12072-019-09943-6
PMID: 30977033
Medical condition
Hepatitis B
Product
adefovir, tenofovir disoproxil fumarate
Collaborators
Not applicable
Study date(s)
March 2011 to December 2016
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18 - 69 years
Accepts healthy volunteers
No
- 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
- subjects with hepatocellular carcinoma (HCC) potential or decompensated liver disease
- subjects with acute liver disease due to other causes
Inclusion and exclusion 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
Trial location(s)
Study documents
No study documents available.
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2012-17-10
Actual study completion date
2016-06-12
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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