Phase 3
N=512
Efficacy and Safety of Tenofovir Disoproxil Fumarate (TDF) 300mg in Chinese Subjects With Chronic Hepatitis B (CHB)
Hepatitis B
Bottom Line
View on ClinicalTrials.gov: NCT01300234 ↗Enrolled (actual)
512
Serious AEs
6.3%
Results posted
Aug 2013
Primary outcome: Primary: Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) <400 Copies/Milliliter (mL) at Week 48 — 79; 18; 149; 109 Participants — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Tenofovir disoproxil fumarate (TDF) tablets (Drug); Adefovir dipivoxil (ADV) tablets (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Oct 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) <400 Copies/Milliliter (mL) at Week 48 |
79; 18; 149; 109 | <0.0001 sig |
| SECONDARY Participants With HBV DNA <400 Copies/mL at Weeks 96, 144, 192, and 240 |
95; 92; 144; 143; 97; 95 | — |
| SECONDARY Change From Baseline of Log 10 Copies/mL HBV DNA at Weeks 48, 96, 144, 192 and 240 |
-6.4; -4.4; -4.9; -4.3; -6.5; -6.5 | — |
| SECONDARY Number of Participants With Alanine Aminotransferase (ALT) Normalization at Weeks 48, 96, 144, 192 and 240 in Participants Who Had Abnormal ALT at Baseline |
88; 83; 120; 116; 93; 88 | — |
| SECONDARY Number of Participants With Histological Improvement at Weeks 48 and 240 Who Had a Baseline Knodell Necroinflammatory Score (KNS) >=2. |
31; 39; 32; 34; 5; 2 | — |
| SECONDARY Number of HBeAg-positive Participants Achieving HBeAg Loss and HBeAg Seroconversion at Weeks 24, 48, 96, 144, 192 and 240. |
15; 4; 14; 4; 18; 10 | — |
| SECONDARY Number of HBeAg-positive Participants Achieving Hepatitis B Surface Antigen (HBsAg) Loss and HBsAg Seroconversion at Weeks 24, 48, 96, 144, 192 and 240 |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of HBeAg-negative Participants Achieving HBsAg Loss and HBsAg Seroconversion at Weeks 24, 48, 96, 144, 192, 240 |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants Achieving Durable HBsAg Loss From Weeks 24 to Week 48 |
0; 0; 0; 0 | — |
| SECONDARY Number of Participants Achieving Durable HBsAg Loss From Weeks 96 to Week 240 |
1; 0; 0; 1 | — |
| SECONDARY Number of Participants With Virological Breakthrough at Weeks 48, 96, 144, 192 and 240 |
0; 4; 0; 2; 0; 4 | — |
| SECONDARY Number of Participants With Any Serious Adverse Event (SAE) and Any Non-serious Adverse Event (AE) |
140; 121; 12; 20 | — |
| SECONDARY Number of Participants With the Indicated Grade 3 and Grade 4 Treatment-emergent (TE) Laboratory Abnormalities (LAs) |
2; 0; 2; 3; 19; 14 | — |
| SECONDARY Number of Participants With the Indicated Treatment-emergent Laboratory Abnormalities for Serum Creatinine and Serum Phosphorus |
0; 1; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants in the Indicated Category for Renal Laboratory Abnormalities |
1; 0; 0; 0; 0; 0 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01300234). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.