Phase 3
N=46
Effects of Telbivudine and Tenofovir Disoproxil Fumarate Treatment on the Hepatitis B Virus DNA Kinetics in CHB
Hepatitis B Virus
Bottom Line
View on ClinicalTrials.gov: NCT00805675 ↗Enrolled (actual)
46
Serious AEs
0.0%
Results posted
Feb 2012
Primary outcome: Primary: Change in Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Level From Baseline to Week 12. — -3.852; -4.175; -4.374 log10 copies/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Telbivudine (Drug); Tenofovir (Drug); Telbivudine plus tenofovir (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Dec 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Level From Baseline to Week 12. |
-3.852; -4.175; -4.374 | — |
| SECONDARY Change in Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Level From Baseline to Weeks 2, 4 and 8. |
-2.657; -2.541; -2.689; -2.985; -3.060; -3.225 | — |
| SECONDARY Percentage of Patients Who Are Polymerase Chain Reaction(PCR)Negative at Week 12 |
0.0; 0.0; 0.0 | — |
| SECONDARY Percentage of Patients Who Achieve Hepatitis B "e" Antigen (HBeAg) Loss and HBeAg Seroconversion at Week 12 |
0; 0; 0 | — |
| SECONDARY Characterization of Very Early Viral Kinetics Through Estimated Viral Load |
8.9; 8.7; 8.7 | — |
| SECONDARY Characterization of Very Early Viral Kinetics Through Viral Clearance |
0.98; 1.19; 1.08 | — |
| SECONDARY Characterization of Very Early Viral Kinetics Through Rate of Infected Cell Loss |
0.04; 0.06; 0.05 | — |
| SECONDARY Characterization of Very Early Viral Kinetics Through Efficiency Factor of Blocking Virus Production. |
98.8; 99.0; 99.1 | — |
| SECONDARY Characterization of Very Early Viral Kinetics Through Half-live of Free Virus |
18.1; 16.4; 18.9 | — |
Summary
The purpose of this study is to compare the safety, tolerability and effectiveness of 12 weeks of treatment with telbivudine 600 mg daily plus tenofovir DF 300 mg one daily (OD) taken together vs. tenofovir DF 300 mg once daily (QD) or vs telbivudine 600 mg monotherapy daily (QD). This is an open labeled, active controlled, viral kinetics study which means the subjects and study doctor will know what study drug subjects have been assigned. This study is open to male and female subjects, <40 years of age, who have been infected with HBV for at least 6 months and have not received oral treatment for HBV.
Eligibility Criteria
Inclusion Criteria
- Chronic HBV infection, defined as positive serum HBsAg for at least 6 months, or HBsAg positive > 3 months and negative for IgM anti-HBc and positive for IgG anti-HBc
- Age or = to 10^7 copies/mL by Abbott real-time PCR
- ALT 1.2 × ULN, PT > 1.2 × ULN, platelets 50 ng/mL
- Evidence of hepatocellular carcinoma (HCC)
- Co-infection with HCV (by serology), or HIV,
- Significant renal, cardiovascular, pulmonary, or neurological disease.
- Received solid organ or bone marrow transplantation.
- Is currently receiving therapy with immunomodulators (e.g., corticosteroids, etc.), investigational agents, nephrotoxic agents, or agents susceptible of modifying renal excretion.
- Has proximal tubulopathy.
- Use of other investigational drugs at the time of enrollment, or within 30 days
- History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes
- Is pregnant or breastfeeding.
- Is a women of child-bearing potential (WOCBP)unless post-menopausal or using one or more acceptable method of contraception.
- Patient has any other concurrent medical or social condition likely to preclude compliance with the schedule of evaluations in the protocol, or likely to confound the efficacy or safety observations of the study.
- Patient is currently abusing alcohol or illicit drugs, or has a history of alcohol abuse or illicit substance abuse within the preceding two years.
- Patient has a medical condition that requires prolonged or frequent use of systemic acyclovir or famciclovir.
Other protocol-defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT00805675). 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.