| December 15, 2006 |
| December 22, 2008 |
| December 2006 |
| February 2008 (final data collection date for primary outcome measure) |
| Characterize the change in mean hepatitis B virus (HBV) DNA level for telbivudine and entecavir. [ Time Frame: from baseline to week 12 ] [ Designated as safety issue: No ] |
| Characterize the change in mean hepatitis B virus (HBV) DNA level from Baseline to Week 12 for telbivudine and entecavir. |
| Complete list of historical versions of study NCT00412529 on ClinicalTrials.gov Archive Site |
- Change in mean HBV DNA level [ Time Frame: from Baseline to Weeks 2, 4, and 8 ] [ Designated as safety issue: No ]
- Characterization of very early viral kinetics through estimation of various parameters [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]
- Change in ALT (alanine aminotransferase) levels [ Time Frame: from Baseline to Week 12 ] [ Designated as safety issue: No ]
- The area under the curve (AUC) of HBV DNA change [ Time Frame: from Baseline to Week 12 ] [ Designated as safety issue: No ]
- % patients who are polymerase chain reaction (PCR) negative [ Time Frame: at Week 12 ] [ Designated as safety issue: No ]
- Safety assessed by adverse events and laboratory values [ Time Frame: Baseline to week 16 ] [ Designated as safety issue: No ]
|
- • Change in mean HBV DNA level from Baseline to Weeks 2, 4, and 8
- Characterization of very early viral kinetics through estimation of various parameters
- Change in ALT (alanine aminotransferase) levels from Baseline to Week 12
- The area under the curve (AUC) of HBV DNA change from Baseline to Week 12
- % patients who are polymerase chain reaction (PCR) negative at Week 12
- Safety assessed by adverse events and laboratory values
|
| |
| Viral Kinetics Study of Telbivudine and Entecavir in Adults With Chronic Hepatitis B |
| A Randomized, Open-Label, Controlled, Multicenter, Exploratory Trial to Characterize the Results of Daily Oral Administration of Telbivudine (LDT600) 600 mg or Entecavir (ETV) 0.5 mg Given Over 12 Weeks on the Kinetics of Hepatitis B Virus (HBV) DNA in Adults With HBeAg-Positive, Compensated Chronic Hepatitis B (CHB) |
This exploratory study is designed to determine the early viral kinetic profile during treatment with telbivudine or entecavir at multiple timepoints over 12 weeks. |
| |
| Phase III |
| Interventional |
| Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
- Hepatitis B
- Chronic Hepatitis B
|
- Drug: entecavir
- Drug: Telbivudine
|
| |
| |
| |
| Completed |
| 44 |
|
| February 2008 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Male or female, 18-70 years of age with documented compensated HBeAg-positive chronic hepatitis B
- Able to comply with study regimen and provide written informed consent
Exclusion Criteria:
- Pregnant or breastfeeding
- Unwilling to use double barrier method of contraception
- Co-infected with HCV, HDV or HIV
- Received Hepatitis B therapy in the past
- Use of immunomodulatory therapy in past 12 months
- History of or symptoms of hepatic decompensation or pancreatitis
- Frequent or prolonged use of potentially hepatotoxic or nephrotoxic drugs
- Concurrent medication likely to preclude compliance with schedule of evaluations
- Use of other investigational drugs within 30 days of enrollment
- Abnormal laboratory values during screening
Other protocol-defined inclusion/exclusion criteria may apply |
| Both |
| 18 Years to 70 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Korea, Republic of |
| |
| NCT00412529 |
| External Affairs, Novartis Pharmaceuticals |
| CLDT600A2407 |
| Novartis Pharmaceuticals |
| Idenix Pharmaceuticals |
| Study Director: |
Novartis Pharmaceuticals |
Novartis Pharmaceuticals |
|
|
| Novartis |
| December 2008 |
