Efficacy and Safety of Telbivudine in Patients With Chronic Hepatitis B
Withdrawn before enrolling · Phase 4
Conditions studied: Chronic Hepatitis B
In brief
This study is designed to evaluate the efficacy and safety of telbivudine 600mg versus adefovir dipivoxil 10mg in patients with compensated chronic hepatitis B.
Key facts
- Study ID
- NCT00606099
- Run by
- Novartis
- People needed
- 0
- Starts
- 2007-11-01
- Last updated by the study team
- 2012-05-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male or female, at least 18 years of age.
- Patients with compensated chronic hepatitis B who are currently receiving adefovir 10mg once daily.
- Patients must have received adefovir 10mg once daily for at least 48 weeks continuously and have a sub-optimal response to adefovir therapy (≥4log10 copies of HBV DNA/mL).
- Patient is willing to comply with all study requirements.
- Patient is willing and able to provide written informed consent.
You may not qualify if…
- Pregnant or nursing (lactating) women. All women must have a negative pregnancy test at the screening visit.
- Female patients of reproductive potential is unwilling to use double barrier method of contraception (condom plus spermicide or diaphragm plus spermicide).
- Patient is co-infected with hepatitis C virus or HIV.
- Patient has previously taken lamivudine.
- Patient is currently abusing illicit drugs or alcohol.
- Patient is using any investigational drugs or with in the last 30 days.
- Patient is enrolled or plans to enroll in a clinical study involving investigational drug.
- Patient has a history of pancreatitis, hepatic decompsensation, Hepatocellular Carcinoma, or a history of hypersensitivity to telbivudine or adfovir.
- Other protocol-defined inclusion/exclusion criteria may apply.
Where it is running
- Novartis — Atlanta, Georgia, United States
- Novartis — Flushing, New York, United States
- Novartis — Sterling, Virginia, United States
Full record on ClinicalTrials.gov
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