Telbivudine Versus the Combination of Telbivudine and Valtorcitabine in Patients With Chronic Hepatitis B
Phase 2
Completed
- Conditions
- Hepatitis B
- Registration Number
- NCT00128544
- Lead Sponsor
- Novartis
- Brief Summary
This study is being conducted to compare the effectiveness of the combination of valtorcitabine and telbivudine to telbivudine alone in patients with chronic hepatitis B.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 130
Inclusion Criteria
- Clinical history compatible with compensated chronic hepatitis B
Other protocol-defined inclusion criteria may apply.
Exclusion Criteria
- Patient is pregnant or breastfeeding
- Patient is co-infected with hepatitis C virus, hepatitis D virus or HIV
- Patient has previously received lamivudine, adefovir dipivoxil or an investigational anti-hepatitis B virus (HBV) nucleoside or nucleotide at anytime.
Other protocol-defined exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms of telbivudine and valtorcitabine in treating chronic hepatitis B?
How does the combination of telbivudine and valtorcitabine compare to standard-of-care nucleos(t)ide analogs in chronic hepatitis B patients?
Which biomarkers are associated with response to telbivudine-based therapies in patients with chronic hepatitis B?
What are the potential adverse events and management strategies for telbivudine and valtorcitabine combination therapy in chronic hepatitis B?
Are there other nucleoside reverse transcriptase inhibitors (NRTIs) or combination approaches being studied by Novartis for chronic hepatitis B treatment?