Trials / Completed
CompletedNCT00537537
To Evaluate Antiviral Efficacy of Telbivudine in Hepatitis B Antigen Positive (HbeAg-positive) Compensated Chronic Hepatitis B (CHB)
An Open Label, Response Adaptive Study of Telbivudine in Adults With HBeAg Positive Compensated CHB
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 100 (actual)
- Sponsor
- Novartis Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- —
Summary
This study is to evaluate the antiviral efficacy of add-on adefovir to telbivudine in non-responders to telbivudine monotherapy after 24 and 36 initial weeks. Antiviral efficacy is assessed by hepatitis B virus (HBV) DNA non-detectability (PCR \<300 copies/ml) by week 104 with CHB.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Telbivudine |
Timeline
- Start date
- 2007-08-01
- Primary completion
- 2011-06-01
- First posted
- 2007-10-01
- Last updated
- 2017-06-23
Locations
3 sites across 1 country: India
Source: ClinicalTrials.gov record NCT00537537. Inclusion in this directory is not an endorsement.